Professional Documents
Culture Documents
URL http://hdl.handle.net/10722/193054
Submitted by
in July 2013
highly associated with anticipatory nausea and vomiting (ANV). In the local
chemotherapy day ward, almost half of the cancer patients verbalize that they feel
i
anxious and are afraid of turning up for chemotherapy due to the fear of its side
effects. However, clinical measure for treating patients’ anxiety during chemotherapy
therapy, becomes a useful means for cancer patients to relieve their physical and
psychological distress. Yet, massage is not a routine CAM being integrated into the
cancer treatment in Hong Kong, including the target center. Thus, a translational
study is proposed in order to develop a massage program for cancer patients receiving
randomized controlled trials (RCTs) on the use of massage therapy for cancer patients
in relieving their anxiety. The appraisal tool developed by the Critical Appraisal Skills
Programme was used to evaluate the quality of the selected studies. The findings of
the selected studies concluded that massage therapy is effective in relieving anxiety
This translational research proposal will illustrate how such a massage program is
planned. The implementation potential has been assessed and the potential benefits of
massage do outweigh its risks and the costs of running this program. An
ii
evidence-based guideline has been developed to ensure patient safety and increase
gain their support for this massage program. Staff training will be organized and a
pilot study has been designed to test the feasibility of this program.
An evaluation plan has also been developed to assess the effectiveness of this
(STAI-S), is set as the primary patient outcome of this study. In addition, Numerical
Rating Scale (NRS), rating from 0 to 10, will be used as the secondary patient
outcome to measure the severity of nausea and vomiting. Lastly, the satisfaction level
of patients, volunteers and nurses will be measured using a 4-point Likert scale.
Therefore, the proposed massage program can be improved and refined according to
the evaluation findings. It is believed that the proposed massage program can reduce
anxiety for cancer patients receiving chemotherapy and thus improving their quality
of life.
iii
The effect of massage therapy in relieving anxiety
by
July 2013
iv
Declaration
I declare that this dissertation represents my own work, except where due
acknowledgement is made, and that it has not been previously included in a theses,
Signed _________________________________
v
Acknowledgements
I would like to express my heartfelt gratitude to my supervisor Miss Idy Fu, who
support throughout these two years has enabled me to complete this dissertation.
postgraduate studies.
Finally, I deeply thank my family and friends for their constant love and support
vi
Table of contents
Declaration .................................................................................................................. v
Acknowledgements ................................................................................................... vi
1.1Background ..................................................................................................... 1
vii
2.3.3 Dropout rate .......................................................................................... 16
viii
3.1.3.1 Potential risks ................................................................................. 31
ix
5.2 Staff training program .................................................................................. 46
References ................................................................................................................. 55
x
Appendix G: Table of evidence ............................................................................... 86
anti-emetics ......................................................................................... 97
xi
Chapter 1: Introduction
reduce their level of anxiety, decreasing the side effects of chemotherapy and
improving their quality of life. This chapter will illustrate the needs and significance
1.1 Background
Department of Health, cancer is the most leading cause of death in Hong Kong,
accounting for 31.2% of all deaths in 2009. Moreover, The Hong Kong Cancer
Registry (2007) reported that the cancer burden in our population is increasing. It is
shown by the continually rising number of new cancer cases, a rate of around 2%
every year, and the steadily increasing life expectancy for both sexes in Hong Kong in
the past 25 years. As well, the survival time for cancer patients has been lengthened
1
2004). However, the increasing number of cancer survivors also implies a longer life
target therapy, causing cancer patients to suffer for longer periods of and more severe
side effects from cancer treatments (Listing, et al., 2009). These lengthy treatments
can cause emotional distress for cancer patients such as anxiety, sense of guilt and
low self-esteem, due to the uncertainty of treatment and disease progression (Lin, et
al., 2011). Thus, such impact becomes an important issue for cancer patients’ quality
survival (Bender, et al., 2002). Chemotherapy can be classified into Curative Intent, to
eradicate tumor cells, and Palliative Intent, to decrease tumor load and symptoms so
as to prolong life. Cancer patients usually suffer from physical and psychological
et al., 2004). Undesirable side effects such as nausea, vomiting, sleep disturbance and
fatigue further increase patients’ psychological distress (Lin, et al., 2011). A study
showed that 15-40% of cancer patients suffered from psychological disorders related
to anxiety and depression during chemotherapy, and that anxiety highly contributed to
the incidence of pre-therapy and post-therapy nausea and vomiting (Molassiotis, et al.,
2002).
2
There has been an increase in cancer patients seeking complementary and
common treatment side effects and disease symptoms over the past decade (DiGianni,
et al., 2002). The National Center for Complementary and Alternative Medicine
(NCCAM) (2010) defines CAM as “a group of diverse medical and health care
systems, practices, and products that are not presently considered to be part of
and herbal medicine (Yang, et al., 2008). The Hong Kong Breast Cancer Registry
(2011) also reported that 33.5% of breast cancer patients received CAM.
Massage is one of the common CAM practices employed to relieve anxiety, pain
and nausea for cancer patients and has been widely used as a treatment for over 3000
years (Quattrin, et al., 2006). Massage is defined as ‘a rhythmic form of touch done by
In the local chemotherapy day ward, almost half of the cancer patients admitted
for receiving chemotherapy verbalize that they feel anxious and are afraid of turning
up for chemotherapy due to the fear of its side effects. Those patients manifest anxiety
3
by developing hand tremors, restlessness, nausea and vomiting before administration
ANV is defined as developing nausea and vomiting during the 24 hour period
discomfort and suffer from chemotherapy side effects despite the use of anxiolytic
agents (Billhult, et al., 2007). Eventually, these anticipatory problems and undesirable
side effects further exaggerate the level of anxiety that is already present with the
cancer diagnosis, and therefore worsening the patient’s quality of life (Lin, et al., 2011).
Some cancer patients even refuse or defer chemotherapy due to the fear of its
associated side effects. This delay in receiving treatment then lowers their chance of
Currently, patients’ anxiety and ANV can only be improved by reassurance from
4
shortage of manpower. Moreover, the choice of anxiolytic and anti-emetic drugs are
limited and not recommended since their side effects may induce drowsiness, further
worsening the patients’ fatigue and concentration (Traeger, et al., 2012). On the other
hand, the clinical psychologist will only be referred in the target clinic if the cancer
period for such a consultation is often more than two weeks once a referral is
recommended.
A local survey (Williams, et al., 2010) reported that massage becomes a useful
means for cancer patients in dealing with such physically and psychologically
stressful treatments for enhancing their quality of life. However, massage is not a
routine CAM being integrated into cancer treatment in Hong Kong, including the
target center. Discussions about massage therapy between cancer patients and health
care professions are also uncommon in the target center. To date, no study has been
receiving chemotherapy in relieving anxiety and thus reducing the severity of ANV.
5
patients undergoing chemotherapy cannot be neglected. Ineffective coping of anxiety
may cause anxiety disorders and depression, which has been estimated to be 4 times
more common in cancer patients compared to the general population (Corbin, 2005).
Anxiety may also exacerbate cancer patients’ physical symptoms such as nausea,
vomiting, insomnia, fatigue and decreased appetite, which will further impair their
quality of life (Corbin, 2005). Massage therapy is believed to help cancer patients to
interrupt the cycle of distress and induce a relaxation response, thus, improving their
quality of life (Ahles, et al., 1999). It is also believed to have a boosting effect on the
immune system and an increase in serotonin level which reduces muscle tension and
Current oncology treatment has evolved from merely cancer killing to enhancing
patients’ comfort throughout their treatment and recovery phases (Currin & Meister,
et al., 2008). There is a growing need in CAM to augment cancer care. However,
discussion on the use of massage between nurses and cancer patients remains
uncommon in most clinical settings (Ahn, et al., 2006). Health care professionals are
patients (Li, et al., 2010). With the increasing use of massage therapy within the
community, nurses have an obligation to provide information and service for cancer
6
patients to reduce their anxiety and mood disturbance, assisting them in going through
selected studies.
7
Chapter 2: Critical Appraisal
In this chapter, a literature review is performed with the detailed search strategies
recommendations are made after summarizing and synthesizing the data extracted
Both electronic and manual searches were performed from 29th July 2012 to 30th
August 2012 to identify eligible studies for a comprehensive literature review. Five
electronic databases: Medline (OvidSP) (1946 to July Week 3 2012), CINAHL Plus
Several keywords were used to limit the number of literature results related to
the chosen topic. The keywords used were grouped according to population (Cancer,
Inclusion and exclusion criteria were developed to select eligible studies. For
8
the inclusion criteria, studies must be randomized controlled trials (RCTs). RCTs
have the highest level of evidence to examine the effectiveness of the studied
intervention (Petrisor & Bhandari, 2007). Studies should be written in English since
the author is unable to translate the studies appropriately and precisely into English.
The participants of the studies should be cancer patients aged 18 or above, as the
target population is adult cancer patients. Moreover, massage therapy should be the
were not included to avoid any confounding effect. Also, the included studies had to
have at least one outcome measure relating to anxiety. Any unrelated massage such as
Details of the search history and a summary of the search results are shown in
appendix A and B respectively. After manual screening using the inclusion and
exclusion criteria and discarding duplicated ones, nine studies were identified. A
manual search from the reference list was also performed and no further studies were
All of the nine selected papers were published from 1999 to 2011. The
9
majority of these were conducted in western countries: three in the USA (Ahles, et al.,
1999; Hernandez, et al., 2004; Post-White, et al., 2003), two in the UK (Soden, et al.,
2004; Sharp, et al., 2010), one in Germany (Listing, et al., 2010), two in Sweden
(Billhult, et al., 2007; Billhult, et al., 2008) and one in Taiwan (Jane, et al., 2011).
Massage therapy was the only different treatment used between the
intervention and control groups in all studies. Participants of both the intervention and
control groups within each study (N=9) were given the service in the same
environment such as a quiet and private room to minimize any confounding factors
The quality of the studies was evaluated by the Critical Appraisal Skills
Programme (Guyatt, Sackett, & Cook, 1993, 1994). Its RCTs checklist, which
consists of 10 questions, was used as the appraisal tool to guide the review. Detail of
the RCTs checklist is shown in appendix D. Then, the level of evidence for all
selected studies was classified using the Scottish Intercollegiate Guidelines Network
(cancer patients), intervention (massage therapy) and the outcomes related to anxiety.
All studies are RCTs which was considered to have the most powerful and convincing
10
evidence on the causal effect between interventions and study outcomes (Petrisor &
Bhandari, 2007).
their method used for randomization. Four studies were using sealed opaque
envelopes (Soden, et al., 2004; Bullhult, et al., 2007; Billhult, et al., 2008; Sharp, et
al., 2010); one study used a computer program (Jane, et al., 2011); one study used a
simple randomization list (Listing, et al., 2010) and one study used the flip of a coin
between intervention and control groups at the entry of the trials. Only one study
showed significantly more women in the control group than the intervention group
It was not feasible to ‘blind’ participants for the group assignments. They
would know whether they were in the control group receiving usual care, or the
obtained from the participants prior to the treatment allocation. Concealment was
achieved. Three studies had enough participants to have a statistical power of 80%
11
(Hernandez-Reif, et al., 2004; Post-White, et al., 2003; Billhult, et al., 2008), and two
studies had enough participants to reach the power of 95% (Sharp, et al., 2010; Jane,
et al., 2011). However, one study’s sample size was less than expected (Soden, et al.,
2004), and three studies did not set minimum sample size to achieve certain statistical
power (Ahles, et al., 1999; Listing, et al., 2010; Bullhult, et al., 2007). Those with
whether the outcome was a real effect from massage therapy or due to some
characteristic of the participants, causing a risk for inducing type II errors (Soden, et
al., 2004).
All nine studies used self-assessment tools for primary outcome data
collection. Some studies (N=5) used one-dimensional tools such as State Trait
Anxiety Inventory (STAI), visual analogue scale (VAS) on relaxation, mood and
nausea (Ahles, et al., 1999; Hernandez-Reif, et al., 2004; Billhult, et al., 2007;
Billhult, et al., 2008; Jane, et al., 2011). The reliability and validity of these tools are
tool, the Hospital Anxiety and Depression Scale (HADS) was also used to measure
the change in anxiety and depression level for the participants (Soden, et al., 2004;
Sharp, et al., 2010; Billhult, et al., 2007; Billhult, et al., 2008). Its validity was also
verified (Zigmond & Snaith, 1983). Furthermore, some multi-dimensional tools, the
12
Profile of Mood States (POMS), the Mood Rating Scales (MRS) and the Berlin Mood
Questionnaire (BMQ) had been used to measure participants’ mood states and quality
of life in 3 studies (Post-White, et al., 2003; Listing, et al., 2010; Sharp, et al., 2010).
These tools consist of several subscales measuring participants’ anxiety level and
their reliability was also well established (Redd, et al., 1991; Anderson, et al., 2000;
Hoerhold & Klapp, 1993). All of the assessment tools used were self reported
All nine studies present their results precisely using mean change, percentage
change and effect size of the scores by different well established measuring tools. All
studies set 5% as the level of significance. Six studies showed the baseline scores and
change in post intervention scores in the form of tables, while the other three studies
(Post-White, et al., 2003; Listing, et al., 2010; Jane, et al., 2011) presented the results
in the form of both tables and graphs of mean score over time. All tables and graphs
were clearly presented with the p-value provided so that the effect of massage therapy
According to the above critical appraisal, three studies (Sharp, et al., 2010;
Hernandez-Rief, et al., 2004; Jane, et al., 2011) were graded as the highest quality
13
RCTs with a very low risk of bias (1++) while four studies (Ahles, et al., 1999;
Post-White, et al., 2003; Listing, et al., 2010; Billhult, et al., 2007) were rated 1+ with
a low risk of bias. The remaining two studies (Soden, et al., 2004; Billhult, et al.,
2008) were labeled as high risk of bias (1- ). A detailed quality assessment of each
The contents of the selected studies were reviewed and data were extracted
using tables of evidence. The tables of evidence for each study are itemized in
appendix G and the summary is briefly described. Appendix H clearly shows a table
All participants in the nine studies were cancer patients and five of them were
breast cancer female patients (Sharp, et al., 2010; Hernandez-Reif, et al., 2004;
Listing, et al., 2010; Billhult, et al., 2007; Billhult, et al., 2008). Also, participants in
five studies were receiving chemotherapy during the study period (Ahles, et al., 1999;
Sharp, et al., 2010; Post-White, et al., 2003; Billhult, et al., 2007; Jane, et al., 2011).
This population is the same as that in the local setting, a chemotherapy day ward,
where breast cancer patients are the majority in the population. These patients require
a relatively longer treatment period, about one and a half years to receive target and
14
conventional chemotherapy. In addition, women with breast cancer are a vulnerable
group among cancer patients since they are at higher risk for depression, elevated
The mean age of participants ranged from 41 to 62.5 in eight studies except
one study with a median age of 73 (Soden, et al., 2004). This is similar to the peak age
group among the prevalence of cancer in Hong Kong, aged 45-64 (Hong Kong Cancer
Registry, 2009). Therefore, the results of the studies should be applicable to the local
clinical setting.
Although no adverse effect was reported in all the selected studies, some
literature showed that massage might increase the risk of fractures and dislocation,
(Corbin, 2005). Participants in all the studies required doctor approval before entering
the studies. In addition, assessment had been done in some studies to exclude cases
with underlying medical conditions such as lymphoedema, inflamed skin in the area
syndrome and deep vein thrombosis (Hernandez-Reif, et al., 2004; Listing, et al.,
2010; Jane, et al., 2011). Moreover, Post-White, et al. (2010) stated that the massage
technique and the area of massage should be modified and adjusted to avoid tumor or
15
surgical sites. The study also suggested that the depth of touch should be limited
ensure that participants understand the purpose of the program and the risk of the
intervention, even though the adverse effect of massage therapy reported to be very
The dropout rate among the selected studies ranged from 0-29%. Eight studies
had a dropout rate less than 20%. Some studies tried to minimize the possibility of
(Hernandez-Rief, et al., 2004; Jane, et al., 2011) and progressive muscle relaxation
(Listing, et al., 2010) after completion of the studies. Eventually their dropout rates
were lowered to 0% (Hernandez-Rief, et al., 2004), 6.9% (Jane, et al., 2011) and
14.7% (Listing, et al., 2010). One study (Post-White, et al., 2003) had a dropout rate
of 29% and it explained that the participants left the study due to their advancing
disease causing a subsequent change in their treatment plan or the participants died
before completion of the study. Nevertheless, no differences had been detected from
16
In addition, all dropout participants in all the studies were included to which
they were originally allocated for intention-to-treat analysis so that all participants
were accounted for at the conclusion to ensure the validity of the results (Montori &
Guyatt, 2001).
2.3.4 Intervention
patients has been demonstrated among the selected studies. After implementing
massage therapy for cancer patients, two of them found that the mean STAI-S scores
Hernandez-Reif, et al., 2004). One study had significant decrease in median HAD
scores by 2 after massage therapy (P≦0.05) (Soden, et al., 2004). Sharp, et al. (2010)
also found that the mean difference of MRS relaxation subscale had significantly
reduced by ≧18 (P≦0.02). Post-White,et al. (2003) showed that the mean difference
(P≦0.02). In addition, Listing, et al.’s study (2010) calculated the effect size of
BMQ-anxious depression as 0.9 (P<0.05) in the study while Jane, et al.’s study (2011)
got a significant improvement in VAS- relaxation in their study with effect size ≧
0.45 (P≦0.03). Only 2 studies failed to prove the effect of massage in reducing
anxiety (Billhult, et al., 2007; Billhult, et al., 2008). However, the mean change of
17
VAS nausea in Billhult, et al. study (2007) had significantly improved (P=0.025).
Although the STAI-S score in Billhult, et al.’s study (2008) was not significantly
improved, this score from their intervention group had still been greatly reduced.
Small sample size was the major cause for these diverse results, recruiting only 19
(Billhult, et al., 2007) and 11 (Billhult, et al., 2008) participants into each treatment
group in their studies. Small sample size might alter the results caused by
confounding factors such as age and disease prognosis of the participants other than
the effect of the interventions (Gurusamy, et al., 2009). Nevertheless, none of the
massage therapy and five of them showed significant effect in anxiety reduction
(Ahles, et al., 1999; Hernandez-Reif, et al., 2004; Post-White, et al., 2003; Listing, et
al., 2010; Jane, et al., 2011). Swedish massage is the technique of using smooth, long,
rhythmical strokes and gentle kneading of the body. This type of massage is soft and
Five studies applied massage over the participants’ whole body and upper part
al., 2004; Ahles, et al., 1999; Post-White, et al., 2003; Listing, et al., 2010; Jane, et al.,
18
2011). However, only one study was conducted in a Chinese country, Taiwan (Jane,
et al., 2011).
Majority of the studies (N=6) set the duration of the massage therapy as 20-30
minutes (Soden, et al., 2004; Ahles, et al., 1999; Hernandez-Reif, et al., 2004; Listing,
et al., 2010; Billhult, et al., 2007; Billhult, et al., 2008). Three of the studies (Ahles, et
al., 1999; Hernandez-Reif, et al., 2004; Listing, et al., 2010) showed significant
improvement in anxiety and one of them showed a reduction in the sense of nausea
The frequency of massage sessions among the studies was discrete. Some
studies performed massages weekly over 4 to 8 weeks (Soden, et al., 2004; Sharp, et
al., 2010; Post-White, et al., 2003) while some studies performed massages two to
three times weekly over 3 to 5 weeks (Ahles, et al., 1999; Hernandez-Reif, et al.,
2004; Listing, et al., 2010; Billhult, et al., 2008). One study implemented massage
therapy concurrently with chemotherapy for 5 cycles (Billhult, et al., 2007); and one
After summarizing and synthesizing the data from the selected studies, it can
19
cancer patients. As such, it is proposed to implement a massage program in the target
western countries. They might feel as though they are being violated by others due to
excessive physical contact. The studies of Billhult, et al. (2007) and Billhult, et al.
(2008) also stated that participants preferred to receive massage on their foot and
lower leg rather than hand and lower arm if choice was provided. Moreover, patients
in the target center will receive chemotherapy via peripheral vein over their hands and
lower arms. Therefore, foot and lower leg massage is preferred to avoid cancer
20-30 minutes is seen as suitable for the target population since the
massage therapy as 20-30 minutes can minimize a prolonged stay in the day ward for
the target participants. In addition, frequent hospital visits may cause fatigue for
participants and thus affect the outcomes and dropout rate of a massage program.
Therefore, the frequency of massage proposed for the target chemotherapy day ward
20
every 3 weeks.
Although all of the studies used self reported questionnaires to measure the
subjective feeling of anxiety for cancer patients, the measuring tools used amongst the
tool is preferred to provide a simple, reliable and direct measure for the proposed
innovation (Seligman, et al., 2001). The STAI consists of two 20-items instrument
with a four point Likert Scale to measure current anxiety level (state anxiety), and the
tendency to experience anxiety (trait anxiety) (Spielberger, 1983). The higher score in
STAI indicates the high level of anxiety. The STAI-state portion (STAI-S) is
recommended to measure the current change in anxiety level before and after the
proposed massage therapy. Its reliability and validity have been well proven and the
internal consistency alpha coefficients of the state portion ranged from 0.82 to 0.92
appendix N, is readily available and its reliability and validity has been well
established (Shek, 1993). Thus, it will be used for the proposed massage program as
the target participants are all Chinese. A detailed evaluation plan will be elaborated in
chapter 4.
21
30-minute Swedish massage on foot and lower legs for cancer patients undergoing
each cycle of chemotherapy in a local chemotherapy day ward to relieve their anxiety
22
Chapter 3: Translation and Application
translated and applied to the target local setting (Polit & Beck, 2008).
In this chapter, the transferability and the feasibility of the massage innovation
are examined. The potential risks, benefits and the cost of the proposed program are
public hospital. Cancer patients must be seen and reviewed by oncologists during
each follow-up to ensure their suitability for each cycle of chemotherapy. Cancer
patients will then be admitted to the day ward on the same day or the day after the
innovation will be implemented on those chairs since massage can be applied to the
23
cancer patient in a seated position, as was the case in three reviewed studies (Billhult,
chemotherapy day ward. Due to their heavy workload, it might not be feasible for
them to perform the massage in the proposed program. The cancer patient resource
centre of the target hospital will allocate a total of 25 volunteers. Five volunteers will
stay in the day ward each day to provide counseling for the cancer patients. These
volunteers are also cancer patients who have completely recovered. They are well
trained and qualified with more than 3 years experience on communicating and taking
care of cancer patients. Some of the reviewed studies (Ahles, et al., 1999; Billhult, et
al., 2007; Hernandez-Reif, et al., 2004) recruited self-trained nurse’s aides to perform
train volunteers to perform the massage to cancer patients who are waiting for their
Patients from both the reviewed studies and the target setting are cancer patients
According to the annual statistics in the target setting, there were 11,692 cancer
24
patients admitted to the target setting with the mean age of 58 last year. This is similar
to those from the reviewed studies that the mean age ranged from 41 to 62.5 years old.
One reviewed study (Jane, et al., 2011) was conducted in Taiwan in which all
participants were Chinese with 76% believed in Buddhism or Taoism. This is also
comparable to the target patients as the majority of them are Chinese and also believe
massage is one of the complimentary methods for adult cancer patients in Hong Kong
involved participants that were currently receiving chemotherapy (Ahles, et al., 1999;
Billhult, et al., 2007; Jane, et al., 2011; Post-White, et al., 2003). Therefore, the target
patients in the proposed setting have similar characteristics as the patients in the
reviewed studies.
healthcare professionals should not only give patients life-saving treatment but also
empower them to regain their health, optimizing their quality of life. Cancer patients
are not merely facing physical distress but they also experience psychological distress
such as anxiety during their chemotherapy treatment (Ahles, et al., 1999; Bullhult, et
al., 2008).
25
The massage innovation falls within this prevailing philosophy of care. As
cancer patients are seeking alternative ways to improve their quality of life, oncology
nurses have an obligation to ensure cancer patient’s quality of life in their cancer
trajectory. Therefore, both reviewed studies and the target hospital share the same
philosophy of care.
Billhult, et al., 2007; Hernandez-Reif, et al., 2004; Jane, et al., 2011; Listing, et al.,
2010; Post-White, et al., 2003). They believed that Swedish massage with its light
strokes and kneading technique is soft and gentle enough for cancer patients.
Therefore, Swedish massage will be used as the massage technique in the proposed
program.
The waiting time for cancer patients to start chemotherapy infusion after
admission is about 30 minutes to 1 hour in the day ward. Therefore, the duration of
In the target setting, the total sessions for a majority of chemotherapy treatments
are 4 to 6 sessions. As massage therapy will be given to cancer patients during their
26
second chemotherapy session, a maximum of 5 sessions will be given to each eligible
last for one year. A pilot study will be conducted to assess the feasibility and examine
any difficulties encountered during implementing the program. Details of the pilot
Manager of Clinical Oncology, Nurse Consultant, Ward Manager and the Project
Manager of the cancer patient resource center who supervises the volunteers. The
Nurse Consultant and the Ward Manager always offer opportunities for staff to attend
conferences to update their professional knowledge. They share the latest research
findings with colleagues and develop evidence-based guidelines for clinical use. As
27
cancer treatment and service for patients. It is foreseeable that such a supporting and
experienced team will give positive support for implementing the proposed program.
nurses and enrolled nurses, being rotated in the outpatient clinics within the
department. These frontline staff have already noted that anxiety is one of the most
chemotherapy after their admission. The proposed massage program can reduce
anxiety and thus comfort anxious patients. This will then shorten nurses’ time spent
evidence-based practices and its benefits for patients. The APN of the target setting
arranges lessons for nurses to update their clinical knowledge and practices related to
oncology care based on literature evidences. For example, she has illustrated the best
practice of central venous catheter care in order to reduce risk of infection last year.
28
All frontline nurses demonstrate supportive attitudes to change of current practices
However, there are two possible factors that may undermine efforts to implement
the proposed massage program. Firstly, nurses need to spend time to attend training
sessions for the massage program during their working hours. It may increase the
workload of the other nurses who remain in the clinic during the training session.
Secondly, the change in current practice may cause stress to nurses because of the
In order to avoid disturbing the daily operation of the out-patient clinics and
chemotherapy day ward during the training sessions, two identical two-hour training
sessions will be held in the conference room of the department. All nurses and the
volunteers recruited will be invited to attend one of the training sessions. Also, the
training sessions will be held on Friday from 3:30 pm to 5:30pm when it is less busy
in all clinics and chemotherapy day ward. The Advanced Practice Nurse, experienced
responsible for the trainings. Patient benefits, program logistics, nursing assessment,
evaluation method of the innovation and the massage guideline will all be introduced
that they are only required to perform the assessment, using a self-designed
29
assessment form, and supervise the volunteers who perform the massage. Details of
registered nurses (RNs) will be established to organize, implement and evaluate the
massage program. The working group will supervise nurses and the trained volunteers,
and monitor the progress of the massage program. All nurses will be welcome to
consult the working group if they have any query during the implementation period to
Massagists for the proposed program will be chosen from the volunteer staff at
the Patient Resource Center. The goal of the center is to ensure the best-possible
service towards optimizing cancer patients’ quality of life. The center’s manager and
groups and role playing for cancer patients. This is intended to provide psychological
support and to strengthen their self care ability. They are also familiar with
30
One element of concern stems from the fact that these volunteers are all cancer
patients who have completely recovered. Acting as the massagists in this program
held with the project manager to invite eligible volunteers to join the massage
program. Ten volunteers will be recruited and trained. During the implementation
period, volunteers will only need to perform not more than 2 massages each day to
Chapter 4.
A further source of potential stress for volunteers may result from being
unfamiliar with the massage technique. Therefore, it will be guaranteed that training
will be given before implementing the program and that nurses will supervise them
during the massage intervention. Furthermore, regular meetings with nurses and
volunteers will be conducted for sharing opinions and raising concerns so that any
All nine reviewed studies claimed that massage therapy is a safe treatment with
no adverse effects reported. Moreover, there is no evidence that massage therapy can
spread cancer from its local region to distal body area (Corbin, 2005). Swedish
31
massage is relatively safe when compared to other vigorous massages such as deep
body massage which might cause fracture, haematoma and pulmonary embolism
(Ernst, 2003). Even though complications related to Swedish massage is rare, the
patients with contraindication such as coagulation disorder and deep vein thrombosis
from participating in the program (Billhult, et al., 2007; Post-White, et al., 2003). The
evidence-based guideline for massages will act as a reference for implementing the
program. Trained volunteers are also required to report to the core members promptly
essential to minimize risks for cancer patients receiving massage. The Oncologist’s
approval for patients to receive massage therapy should be obtained during the
patient’s follow-up for the second cycle of chemotherapy. Medical support from
the implementation period. Therefore, a meeting will be arranged with all oncologists
32
necessary for identifying eligible patients for this program and managing patients with
As previously stated, massage therapy can greatly improve both physical and
reported that even a 10 minute leg massage immediately improved pain, nausea and
anxiety in cancer patients. Physiologically, Field (1998) found that massage can
in mood, severity of nausea and sleeping quality. With improvement in these physical
symptoms, and hence quality of life, cancer patients are likely to complete
(Corbin, 2005).
enrich nurse’s professional knowledge about massage and by doing so nurses can
provide a means for cancer patients to consider the information. With the target
setting being able to provide a qualified massage service for cancer patients, this will
33
As massage therapy can be performed by nurses, volunteers and family members
(Reaves & McManis, 2010). If this program can be proved as effective in reducing
anxiety, nurses can teach patient’s families to perform massage for cancer patients
frequently and therefore, better control the patient’s discomfort. Rapport between
nurses, patients and their family members can also be enhanced from this interaction.
Although implementing the program may induce extra workload for nurses, their
effort in managing patients with anticipatory nausea and vomiting will then be
From observation, there are approximately half of the cancer patients admitted to
the day ward behave anxiously. Considering 20% of these patients are eligible and
willing to participate in this program, it is estimated that there will be 1,169 cancer
3.1.3.3 Cost
It may lead to not only delaying their chemotherapy treatment but also being admitted
to the day ward or even to the in-patient unit for rehydration or electrolyte supplement.
This causes extra admission and medical treatments for the patients during their
34
treatment period, increasing medical expenses for cancer patients. As cancer patients
are required to pay an additional $150 for every extra admission, this may increase the
nausea and vomiting was poorly controlled in the previous admission, doctors may
add a potent anti-emetic, i.e. the 5-HT3-receptor antagonist on top of the usual
anti-emetics. Yet, these strong anti-emetics such as Navoban are relatively expensive
($63.5/tablet) when compared with the commonly used anti-emetics such as Maxolon,
($0.08/tablet). These potent anti-emetics also carry more side effects. If implementing
the massage program reduces patient’s anxiety and decreases their severity of nausea
and vomiting, then the use of such costly anti-emetics will be lowered. If the use of
those potent anti-emetics can even be reduced by 20% among the patients in the
massage program, the medication expense can be greatly reduced. The estimated
expense that can be saved is calculated in appendix I. It is estimated that $57,000 will
be saved on the use of potent anti-emetics after cancer patients join the massage
program.
On the other hand, implementing the massage program will bear some material
costs. However, these costs will be limited to stationery and massage oil since
audio-visual aids and the conference venue are already available at the target setting.
35
Assuming that there will be 1,100 cancer patients joining the massage program a year,
the estimated annual budget for running the program will be $12,000. A detailed
The necessary training and preparation for this massage program will require
extra expenditures from the department. However, considering the patient benefits
and the long term cost saved from using costly anti-emetics, it is worth to implement
36
Chapter 4: Evidence-Based Practice Guideline
review conducted in the previous chapter. It provides structural and clear information
for nurses on the use of massage on adult cancer patients receiving chemotherapy to
reduce anxiety in the target hospital. The level of evidence and recommendations
extracted from the nine RCTs are graded according to the Scottish Intercollegiate
working group will be formed to include Clinical Oncologists, the Nurse Consultant
and the Ward Manager to develop and review the guideline regularly to ensure its
quality and applicability. The aim, objectives, target population and recommendations
are extracted and shown below. A detailed EBP guideline is available in appendix L.
4.1 Aim
4.2 Objectives
37
4.3 Target population
The massage therapy is applicable to both male and female adult cancer patients
Inclusive criteria
- Aged 18 or above
- Cognitively competent
Exclusive criteria
- Coagulation disorder
- Venous thrombosis
- Bone metastasis
- Peripheral neuropathy
- Radiation dermatitis
38
4.4 Recommendations
Recommendation 1.0
open wound over lower limbs are excluded from receiving massage in four of the
reviewed RCTs(Hernandez-Reif, et al., 2004; Jane, et al., 2011; Sharp, et al., 2010;
Listing, et al., 2010). This is necessary as these conditions may heighten the risk of
2004; Jane, et al., 2011; Sharp, et al., 2010; Listing, et al., 2010) (1++; 1++; 1++;
1+).
Recommendation 2.0
(Grade of recommendation: A)
embolism were reported from participants in seven reviewed RCTs which used
Swedish massage as their intervention. (Ahles, et al., 1999; Billhult, et al., 2007;
39
Billhult, et al., 2008; Hernandez-Reif, et al., 2004; Jane, et al., 2011; Listing, et al.,
2010; Post-White, et al., 2003). (1+; 1+; 1-; 1++; 1++; 1+; 1+)
Recommendation 3.0
recommendation: A)
Six reviewed studies used 20-30 minute massage and five of them reported to
have positive effects in reducing level of anxiety and sense of nausea for cancer
patients (Ahles, et al., Billhult, et al., 2007; Billhult, et al., 2008; Hernandez-Reif,
et al., 2004; Listing, et al., 2010; Soden, et al., 2004). The immediate short-term (30
min) benefits of massage therapy is well proved to reduce anxiety for cancer
patients (Hernandez-Reif, et al., 2004; Listing, et al., 2010; Soden et al., 2004).
(1++; 1+; 1- )
Recommendation 4.0
measure the patient’s level of anxiety before and after the massage so as to
recommendation: A)
Five reviewed RCTs used one-dimensional self assessment tools to measure the
subjective feeling of anxiety for cancer patients (Ahles, et al., 1999; Billhult, et al.,
40
2007; Bullhult, et al., 2008; Hernandez-Reif, et al., 2004; Jane, et al., 2011). Three
of them used STAI-S assessment tool to measure anxiety level for cancer patients
and resulted in decrease in their anxiety level (Ahles, et al., 1999; Billhult, et al.,
one-dimensional assessment tool that is short and easy for cancer patients to
41
Chapter 5: Implementation Plan
realization of the massage innovation into the target setting. This chapter will
illustrate a detailed communication, execution and evaluation plan for the massage
innovation among the stakeholders who are the key persons affecting the success of
the program (Burns and Grove, 2005). A good communication plan is needed in order
to give stakeholders a better understanding of and support for the innovation. The
nurses, cancer patients, and volunteers and the manager from the patient resource
centre.
(DOM), the Nurse Consultant and the Ward Manager are the key administrators. They
have the authority to endorse guidelines and interventions used in the target setting.
Therefore, the aims, benefits and costs of this program will be explained to them
42
through meetings and emails to gain their support. In addition, they will be consulted
for opinions to revise the guidelines as necessary, given their rich experiences in
ensure the appropriate patients are selected to receive massage therapy. They will also
provide medical support if patients develop any adverse effects due to massage
therapy such as muscular pain and shortness of breath. Therefore, a meeting with all
10 oncologists will be held to explain the aims and benefits of this massage program.
The frontline nurses will conduct and supervise this massage program while the
volunteers, supervised by their manager from the patient resource centre will perform
the massage interventions. Briefing sessions will be held to explain the purpose of this
innovation to the nurses, manager and the volunteers of the resource centre in order to
gain their support. Training will be provided for the nurses and volunteers with
regards to the knowledge and skills about massage. Details of the briefing and the
about this massage program to different stakeholders effectively. The group will be
comprised of an advanced practice nurse (APN), who is familiar with massage and
43
responsible for the training sessions, and six senior registered nurses, including the
program coordinator. This group will be responsible for organizing, executing and
evaluating the massage program. They will develop and help revising the EBP
massage guidelines. They will monitor and provide knowledge and skills support for
frontline nurses and volunteers when needed during the implementation period.
The communication process will begin with the Ward Manager and the Nurse
Consultant, who are responsible to review new nursing guidelines and innovations
within the department. A meeting will be held with them so that their concern can be
considered and tackled in advance. The working group will convey that anxiety is the
minimize anxiety in those cancer patients. Training of the nurses and volunteers will
also be discussed. The ward manager and nurse consultant will then be invited to give
their advice about the innovation, and the working group will revise the logistics of
the program accordingly. After gaining the initial support from these key personnel,
the idea of this innovation can then be further disseminated to other stakeholders.
to others administrators including the Chief of Service, DOM and oncologists. The
44
presentation will clearly elaborate the current situation of patients’ anxiety during
provided. Their concerns and comments will be used to refine the innovation further.
Communication with the frontline nurses is essential as they are the key persons
who will conduct and monitor the massage program. A briefing session will be held to
disseminate the details of the innovation by the program coordinator in the conference
room of the department. The aim and benefits of the proposed program will be
explained. Its workflow will be elaborated and their concerns will be considered in
The manager of the patient resource centre will also be invited to join the nurses
meeting. This will promote communication between them and assist in selecting
eligible volunteers to join the program. As the volunteers are all cancer survivors, the
selection of eligible volunteers will be based on their medical conditions. This is done
selected volunteers will then join other nurses in the training sessions to learn the
details of the massage program. Ten volunteers will then be recruited into this
(appendix M) is stipulated.
45
5.2 Staff training program
will be held in the conference room of the department every Friday from 3:30 pm to
5:30pm. All nurses working in the chemotherapy day ward and the volunteers
recruited will need to attend one of the training sessions. The APN, having rich
clinical experience and knowledge in performing massage to cancer patients, will hold
the training sessions. Theory, technique and benefits of massage will be explained.
The logistics of the program, nursing assessment, evaluation plan and the massage
guidelines will also be elaborated upon. At the end of the training session, both nurses
and volunteers will be asked to demonstrate the massage technique to the APN. A
checklist designed by the working group will be used for assessing their skills in order
Posters about the program will be placed on the notice board in the
chemotherapy day ward. A leaflet with details of the massage program will be given
to every patient during their admission. If the patients wish to join this program, nurse
will check their eligibility according to the inclusion criteria documented in the
evidence-based guideline. If the patients are eligible, nurse will fill in part 1 of the
assessment form (Appendix N) and file it in the patient’s kardex. Further assessment
46
for eligibility will be performed by oncologists during their second follow up. This is
to ensure no hidden or recently developed illnesses such as venous thrombosis that are
contraindicated to the massage program. Patients will join the massage program only
after getting approval from the oncologists. Then, a 30-minute massage session will
be performed every 3 weeks on the same day when patients return for chemotherapy.
After getting approval from the oncologists, nurses will complete part 3 of the
assessment form when the patients are admitted to the chemotherapy day ward. They
will explain the procedure of massage to the patients and obtain their informed
consent. Patients will be asked to complete the pre-massage form on measuring their
level of anxiety, nausea and vomiting. Nurses will then supervise the trained
volunteers to perform massage and monitor the patient’s condition during the
intervention. Immediately following the massage therapy, the same measurement will
be collected from patients again. Nurses will document on patients’ kardex if they
A pilot study should be conducted to test the feasibility and the logistics of this
program. It is proposed to conduct a pilot test in the chemotherapy day ward with 10
47
cancer patients or setting the pilot period for one month, whichever is achieved first.
The trained nurses and volunteers who will work in the day ward during the pilot
period will be responsible for conducting the pilot test. Meetings with the nurses and
volunteers will be conducted to share their opinions and difficulties encountered at the
end of the pilot study period. Revision and refinement of the program will then be
The working group will monitor the entire innovation process continuously to
ensure the massage program is properly implemented in the target setting. Meetings
with nurses and volunteers will be arranged every 3 months to share their insights on
primary patient outcome of this massage program. Patients’ pre and post-massage
anxiety level will be measured by using the Chinese version of State Trait Anxiety
48
change in anxiety level (Spieberger, 1983). STAI-S was also used by the reviewed
studies to verify the effect of massage in reducing anxiety among cancer patients
The secondary patient outcome will be the change in severity of nausea and
vomiting for patients during the course of massage therapy. A Numerical rating scale
(NRS), rating from 0 to 10, will be used to measure both the severity of nausea and
subjective feelings with established reliability and validity (Ahles,et al., 1999;
anticipatory nausea and vomiting, measuring the severity of nausea and vomiting can
also determine whether the massage program achieves its intended effect (Morrow, et
al., 1998).
nurses to accept and participate in this so that it can be developed and implemented
effectively. Therefore, their satisfaction will be measured after the last session of
massage using a 4-point Likert Scale survey. For the patients who have discontinued
treatment prior to the fifth massage session, the survey will be mailed to them in order
49
5.6.2 Nature and number of clients to be involved
Target patients of this program are adult cancer patients including hematology
malignancy and solid tumor with or without metastasis. The eligibility criteria will be
able to read Chinese; and cognitively competent and being admitted to the
such as coagulation disorder and bone metastasis will be excluded from the massage
program (Hernandez, et al., 2004; Jane, et al., 2011; Sharp, et al., 2010).
In order to determine whether the anxiety level of cancer patients will be reduced
or not after receiving the massage interventions, an adequate sample size is required.
The number of patients is calculated using the one-sample t test analysis (Russ Lenth,
2009). Taking references from the reviewed studies, a mean difference of 5 between
pre- and post-test on the STAI-S score and a standard deviation of 13 will be used to
calculate the sample size required (Ahles, et al., 1999; Hernandez, et al., 2004). A
paired t test with alpha as 0.05 and power 80% are used. It is assumed that there will
Therefore, the number of patients required for joining the program is 60. It is
50
estimated to take six months to recruit 60 cancer patients and have them completed a
STAI-S will be obtained. STAI-S form is a 20-item inventory with each item
measured on a 1-4 numeric rating scale scored from 20-80. The higher the STAI-S
score means the higher the anxiety level of the patients. Since the reviewed studies
reported that massage has an immediate effect on reducing anxiety for cancer patients,
STAI-S scores will be measured immediately before and after each session of
massage (Ahles, et al., 1999; Hernandez, et al., 2004; Listing, et al., 2010; Post-White,
The Statistical Package for Social Sciences (SPSS) version 17.0 will be used to
demographic data. The mean STAI-S scores will be generated at each time of
measurement. Two-tailed paired t-test will be used to analyze the STAI-S scores
51
To evaluate the change in severity of nausea and vomiting during the course of
massage, patients will be asked to grade their feeling of nausea and vomiting by using
NRS (0-10) at 0, 15 and 30 minutes after starting the massage intervention. The mean
respectively and presented by mean, mean difference and standard deviation using
delivering the intervention will be measured using a 4-point Likert scale survey
Moreover, if the mean scores of the satisfaction level among patients, volunteers
and nurses are greater than 2, the massage program will be considered successful.
52
Chapter 6: Conclusion
most commonly reported symptom from the target population in a local chemotherapy
day ward. It has also been demonstrated that elevated anxiety increases the severity of
chemotherapy side effects, anticipatory nausea and vomiting, thus, impairing cancer
patients’ quality of life to a greater extent. Massage is one of the common CAM that
After summarizing and synthesizing the data from the 9 reviewed studies, a 30
patients undergoing chemotherapy was set to ensure patient safety and increase
developed to gain support from the stakeholders in the target chemotherapy day ward.
Also, an evaluation plan was designed to assess the effectiveness of this program.
patients, volunteers and nurses will also be measured to determine whether the
53
It is hoped that this massage program can be realized and implemented in the
target clinical setting in the future. If so, this program should lead to a significant
Ultimately, this can result in a better quality of life for cancer patients in Hong Kong.
54
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63
Appendix A: Search history
Results
64
Database 2: CINAHL PLUS (EBSCOHost) (1967 to 2012)
S1 Cancer 27396
S2 Neoplasms 33609
S3 Oncology 4411
S4 Carcinoma 5225
S5 Malignancy 958
S6 Chemotherapy 4320
S7 Massage 731
S8 Complementary therapies 316
S9 Alternative therapies 3953
S10 Alternative medicine 921
S11 Anxiety 9437
S12 Anxiety disorders 2029
S13 Psychological discomfort 17
S14 Relaxation 1331
S15 Mood disturbance 101
S16 Anticipatory nausea 12
S17 Anticipatory vomiting 11
S18 S16 or S17 14
S19 S1 or S2 or S3 or S4 or S5 45559
S20 S7 or S8 or S9 or S10 4741
S21 S11 or S12 or S13 or S14 or S15 or S18 12701
S22 S19 and S6 and S20 and S21 14
Results
65
Database 3: British Nursing Index (ProQuest)
S1 Cancer 12441
S2 Neoplasms 11
S3 Oncology 3153
S4 Carcinoma 148
S5 Malignancy 104
S6 Chemotherapy 1332
S7 Massage 436
S8 Complementary therapies 1536
S9 Alternative therapies 2788
S10 Alternative medicine 1092
S11 Anxiety 1925
S12 Anxiety disorders 512
S13 Psychological discomfort 8
S14 Relaxation 282
S15 Mood disturbance 24
S16 Anticipatory nausea 9
S17 Anticipatory vomiting 5
S18 16 or 17 9
S19 1 or 2 or 3 or 4 or 5 12627
S20 S7 or S8 or S9 or S10 2437
S21 S11 or S12 or S13 or S14 or S15 or S18 2649
S22 S19 and S6 and S20 and S21 13
Results
66
Database 4: The Cochrane Library (ProQuest)
ID Search Hits
#1 (Cancer): ti,ab,kw 5732
#2 (Neoplasms): ti,ab,kw 38865
#3 (Oncology): ti,ab,kw 813
#4 (Carcinoma): ti,ab,kw 8898
#5 (Malignancy): ti,ab,kw 26
#6 (Chemotherapy): ti,ab,kw 13891
#7 (Massage): ti,ab,kw 909
#8 (Complementary therapies): ti,ab,kw 359
#9 (Alternative therapies): ti,ab,kw 63
#10 (Alternative medicine): ti,ab,kw 78
#11 (Anxiety) : ti,ab,kw 9584
#12 (Anxiety disorders): ti,ab,kw 3588
#13 (Psychological discomfort): ti,ab,kw 0
#14 (Relaxation): ti,ab,kw 2289
#15 (Mood disturbance): ti,ab,kw 2
#16 (Anticipatory nausea): ti,ab,kw 121
#17 (Anticipatory vomiting): ti,ab,kw 138
#18 (#16 OR #17) 187
#19 (#1 OR #2 OR #3 OR #4 OR #5) 68502
#20 (#7 OR #8 OR #9 OR #10) 1112
#21 (#11 OR #12 OR #13 OR #14 OR #15 OR #18) 19434
#22 (#6 AND #19 AND #20 AND #21) 54
Results
67
Database 5: The PsycINFO database (1800s to 2012)
S1 Cancer 46704
S2 Neoplasms 27785
S3 Oncology 10658
S4 Carcinoma 1051
S5 Malignancy 1108
S6 Chemotherapy 3418
S7 Massage 1010
S8 Complementary therapies 2681
S9 Alternative therapies 11995
S10 Alternative medicine 10578
S11 Anxiety 157408
S12 Anxiety disorders 88889
S13 Psychological discomfort 1798
S14 Relaxation 13090
S15 Mood disturbance 3741
S16 Anticipatory nausea 137
S17 Anticipatory vomiting 108
S18 16 or 17 145
S19 1 or 2 or 3 or 4 or 5 52757
S20 S7 or S8 or S9 or S10 21200
S21 S11 or S12 or S13 or S14 or S15 or S18 179486
S22 S19 and S6 and S20 and S21 33
Results
68
Appendix B: Summary of search results
Electronic search by 49 14 13 54 33
keywords
Limited electronically to 13 10 1 20 20
criteria
RCTs identified 8 0 0 0 1
69
Appendix C: List of selected studies
1. Ahles, T. A., Tope, D. M., Pinkson, B., Walch, S., Hann, D., Whedon, M., Dain,
B., Weiss, J. E., Mills, L.& Silberfarb, P. M. (1999). Massage Therapy for
in Women with Breast Cancer Who Are Undergoing Chemotherapy. The Journal
4. Hernandez-Reif, M., Ironson, G., Field, T., Hurley, J., Katz, G., Diego, M., Weiss,
S., Fletcher, M. A., Schanberg, S., Kuhn, C. & Burman, I. (2004). Breast cancer
5. Jane, S. W., Chen, S. L., Wilkie, D. J., Lin, Y. C., Foreman, S. W., Beaton, R. D.,
Fan, J. Y., Lu, M. Y., Wang, Y. Y., Lin, Y. H. & Liao, M. N. (2011). Effects of
massage on pain, mood status, relaxation, and sleep in Taiwese patients with
70
metastatic bone pain: A randomized clinical trial. The Journal of the
6. Listing, M., Krohn, M., Liezmann, C., Kim, I., Reisshauer, A., Peters, E., Klapp,
7. Post-White, J., Kinney, M. E., Savik, K., Gau, J. B., Wilcox, C. & Lerner, I.
8. Sharp, D. M., Walker, M. B., Chaturvedi, A., Upadhyay, S., Hamid, A., Walker,
A. A., Bateman, J., Braid, F., Ellwood, K., Hebblewhite, C., Hope, T., Lines, M.
312-322.
9. Soden, K., Vincent, K., Craske, S., Lucas, C. & Ashley, S. (2004). A randomized
18, 87-92.
71
Appendix D: RCTs checklist
CRITICAL APPRAISAL SKILLS PROGRAMME (CASP)
Making sense of evidence
10 questions to help you make sense of a
randomised controlled trial
General comments
The questions on the following pages are designed to help you think
about these issues systematically.
The first two questions are screening questions and can be answered
quickly. If the answer to both is "yes", it is worth proceeding with the
remaining questions.
You are asked to record a "yes", "no" or "can't tell" to most of the
questions.
A number of italicised hints are given after each question. These are
designed to remind you why the question is important.
These questions are adapted from: Guyatt GH, Sackett DL and Cook
DJ. Users’ guide to the medical literature II. How to use an article about
therapy or prevention. JAMA; 1993; 270(21): 2598-2601 and JAMA
1994; 271(1): 59-63
72
A. Are the results of the study valid?
Screening Questions
Is it worth continuing?
------------------------------------------------------------------------------------------------------
Detailed questions
73
- If you think it matters in this study
5. Were all of the participants who entered the trial accounted for at its
conclusion?
Consider:
- If, for example, they were reviewed at the same time intervals and if they
received the same amount of attention from researchers and health
workers. Any differences may introduce performance bias.
7. Did the study have enough participants to minimise the play of chance?
Consider:
- Is there a power calculation. This will estimate how many participants
are needed to be reasonably sure of finding something important (if it
really exists and for a given level of uncertainty about the final result)
74
8. How are the results presented and what is the main result?
Consider:
75
Appendix E: Level of evidence
4 Expert opinion
http://www.sign.ac.uk/guidelines/fulltext/50/annexb.html
76
Appendix F: Quality assessment
1) Bibliographic citation: Ahles, et al., 1999 RCT
3. Were participants appropriately Yes. But the randomization method was not
allocation to intervention and described. There was no significant
control groups? difference between groups.
4. Were participants, staff and study No. Blinding was impossible to the study
personnel ‘blind’ to participants’ participants.
study group?
5. Were all of the participants who Yes. Dropout rate was 2.9%. All participants
entered the trial accounted for at its were included in the intent-to-treat analysis.
conclusion?
6. Were the participants in all groups Yes. Same measurement tools were used to
followed up and data collected in collect data for all groups.
the same way?
7. Did the study have enough Can’t tell. The study did not set minimum
participants to minimize the play of sample size to achieve certain statistical
chance? power. The number of patients was n=16 &
18 each group.
8. How are the results presented, and State-Trait Anxiety Inventory-state (STAI-s)
what is the main result? (Higher the score, higher level of anxiety.)
Anxiety level decrease after first and fifth
massage.
9. How precise are these results? Mean change and P value were showed.
10. Were all important outcomes Yes. The result can be applied as the studies
considered so the results can be and target population were the same.
applied?
Level of evidence 1+
77
2) Bibliographic citation: Billhult, et al., 2007 RCT
4. Were participants, staff and study No. Blinding was impossible to the study
personnel ‘blind’ to participants’ participants.
study group?
5. Were all of the participants who Yes. All patients were involved and provided
entered the trial accounted for at data throughout the study period.
its conclusion?
6. Were the participants in all Yes Same measurement tools were used to
groups followed up and data collect data for all groups.
collected in the same way?
7. Did the study have enough Can’t tell. The study did not set minimum
participants to minimize the play sample size to achieve certain statistical power.
of chance? The number of patients was n=19 & 20 each
group.
8. How are the results presented, HADS; VAS-nausea (Higher the score, higher
and what is the main result? the sense of nausea.) no statistically difference
between groups in HADS.
Massage group statistically reduced sense of
nausea than control group.
9. How precise are these results? Mean change, SD, percentage change and P
value were showed.
10. Were all important outcomes Yes. The result can be applied as the studies and
considered so the results can be target population were the same.
applied?
Level of evidence 1+
78
3) Bibliographic citation: Billhult, et al., 2008 RCT
4. Were participants, staff and study No. Blinding was impossible to the study
personnel ‘blind’ to participants’ participants.
study group?
5. Were all of the participants who Yes. All participants were involved and
entered the trial accounted for at provided data throughout the study period.
its conclusion?
6. Were the participants in all Yes Same measurement tools were used to
groups followed up and data collect data for all groups.
collected in the same way?
7. Did the study have enough Yes. The number of participants was enough to
participants to minimize the play achieve a power of 80%. However, the number
of chance? of patients was small (n=11/group).
8. How are the results presented, Number of cells in blood specimen; HADS;
and what is the main result? STAI-s.
No significant change of number of cells,
anxiety and depression identified between
groups.
9. How precise are these results? Median, 25th-75th percentile and P value were
showed.
10. Were all important outcomes Yes. The result can be applied as the studies and
considered so the results can be target population were the same.
applied?
Level of evidence 1-
79
4) Bibliographic citation: Hernandez-Reif, et al., 2004 RCT
4. Were participants, staff and study No. Blinding was impossible to the study
personnel ‘blind’ to participants’ participants.
study group?
5. Were all of the participants who Yes. All participants followed up until the end
entered the trial accounted for at of study.
its conclusion?
6. Were the participants in all Yes Same measurement tools were used to
groups followed up and data collect data for all groups.
collected in the same way?
7. Did the study have enough Yes. The number of patients was enough (N=34)
participants to minimize the play to have power of 80%. But the sample size was
of chance? small (n=18 & 16 on massage and control
group).
8. How are the results presented, STAI-s (Higher the score, higher level of
and what is the main result? anxiety.)
The anxiety level of massage group statistically
lower than the control group.
9. How precise are these results? Mean, percentage change and P value were
showed.
10. Were all important outcomes Yes. The result can be applied as the studies and
considered so the results can be target population were the same.
applied?
80
5) Bibliographic citation: Jane, et al., 2011 RCT
4. Were participants, staff and study No. Blinding was impossible to the study
personnel ‘blind’ to participants’ participants.
study group?
5. Were all of the participants who Yes. Dropout rate was 6.9%. Reasons for the
entered the trial accounted for at its dropout rate were explained. All participants
conclusion? were included for the intent-to-treat analysis.
6. Were the participants in all groups Yes. Same measurement tools were used to
followed up and data collected in collect data for all groups.
the same way?
7. Did the study have enough Yes. The number of patients was enough
participants to minimize the play of (n=36/group) to have power of 95%.
chance?
8. How are the results presented, and Present pain intensity (PPI-VAS); Mood-VAS;
what is the main result? Relaxation-VAS; Sleep-VAS (Higher the score,
higher level of the outcome measures.)
The level of pain, mood and relaxation reduced
in massage group than in control group.
9. How precise are these results? Mean, SD, ES, P value and the graphic results
of means scores for the outcome measures over
time were showed.
10. Were all important outcomes Yes. The result can be applied as the studies and
considered so the results can be target population were the same.
applied?
81
6) Bibliographic citation: Listing, et al., 2010 RCT
4. Were participants, staff and study No. Blinding was impossible to the study
personnel ‘blind’ to participants’ participants.
study group?
5. Were all of the participants who Yes. Dropout rate was 14.7%. All participants were
entered the trial accounted for at included for the intent-to-treat analysis. Difference
its conclusion? of dropouts and completers was compared.
6. Were the participants in all Yes. Same measurement tools were used to collect
groups followed up and data data for all groups.
collected in the same way?
7. Did the study have enough Can’t tell. The study did not set minimum sample
participants to minimize the play size to achieve certain statistical power. The
of chance? number of patients was n= 17/group.
8. How are the results presented, Berlin Mood Questionnaire (BMQ)- subscale
and what is the main result? anxious depression.
The effect size (ES) of anxious depression in
massage group statistically improved at the end of
the 5 weeks intervention period.
9. How precise are these results? Mean, SD, 95% CI, ES and P value were showed.
10. Were all important outcomes Yes. The result can be applied as the studies and
considered so the results can be target population were the same.
applied?
Level of evidence 1+
82
7) Bibliographic citation: Post-White, et al., 2003 RCT
4. Were participants, staff and study No. Blinding was impossible to the study
personnel ‘blind’ to participants’ participants.
study group?
5. Were all of the participants who Yes. Dropout rate was 29%. All participants
entered the trial accounted for at its were included in the intent-to-treat analysis. The
conclusion? reasons for the dropout rate were discussed.
6. Were the participants in all groups Yes Same measurement tools were used to
followed up and data collected in collect data for all groups.
the same way?
7. Did the study have enough No. The number of patients was enough
participants to minimize the play (>32/group) to have power of 80%.
of chance?
8. How are the results presented, and Brief Profile of Mood States (POMS)-anxiety
what is the main result? subscale.
The mean change of anxiety level in massage
group statistically greater than the control
group.
9. How precise are these results? Mean, standard deviation (SD) and P value were
showed.
10. Were all important outcomes Yes. The result can be applied as the studies and
considered so the results can be target population were the same.
applied?
Level of evidence 1+
83
8) Bibliographic citation: Sharp, et al., 2010 RCT
4. Were participants, staff and study No. Blinding was impossible to the study
personnel ‘blind’ to participants’ study participants.
group?
5. Were all of the participants who Yes. Dropout rate was 9.3%. All participants
entered the trial accounted for at its were included in the intent-to-treat analysis.
conclusion? Reasons for the dropout rate were explained.
6. Were the participants in all groups Yes. Same measurement tools were used for
followed up and data collected in the data collection in all groups.
same way?
7. Did the study have enough participants Yes. The number of patients was enough
to minimize the play of chance? (>60/group) to provide power of 95%.
8. How are the results presented, and HADS; Mood Rating Scale (MRS)-relaxation
what is the main result? subscale. (Higher the score, higher level of
anxiety, depression and relaxation.)
MRS-relaxation score in both reflexology
group and massage group was statistically
higher than control group.
9. How precise are these results? Mean, 95% confidence intervals (CI) and P
value were showed.
10. Were all important outcomes Yes. The population of studies’ patients and
considered so the results can be target patients were the same.
applied?
84
9) Bibliographic citation: Soden, et al., 2004 RCT
4. Were participants, staff and No. blinding was impossible to the study
study personnel ‘blind’ to participants. Researchers were blind to the
participants’ study group? interventions.
5. Were all of the participants who Yes. Dropout rate was 14.3%. All participants were
entered the trial accounted for at included in the intent-to-treat analysis. Reasons for
its conclusion? the dropout rate were explained.
6. Were the participants in all Yes. Same measurement tools were used to collect
groups followed up and data data for all groups.
collected in the same way?
7. Did the study have enough No. The number of patients was small (total N=42)
participants to minimize the (<45) and the power of 80% did not reached.
play of chance?
8. How are the results presented, The Hospital Anxiety and Depression Scale (HADS)
and what is the main result? (Higher the score, higher level of anxiety and
depression)
nd
Depression score in HADS decreased after 2 and
th
4 massage.
9. How precise are these results? Mean change, median change and P value were
showed.
10. Were all important outcomes Yes. The result can be applied as the studies and
considered so the results can be target population were the same.
applied?
Level of evidence 1-
85
Appendix G: Table of evidence 1
Study, No. of patients & Interventions Compariso Length of Outcome measures Result/Effect size
Design, Patients n/control follow up
Evidenc characteristic
e level,
Country
1. N=34 n=16 n=18 -First massage 1. State-Trait Mean changes after first massage:
Ahles, et Mean age (SD) Dropout =0 Dropout=1 Anxiety 1. STAI-state: -13.57 (P≦0.0001)
al., 1999 =41(9.3) - 20 minutes - Fifth massage Inventory-state 2. NS
- Swedish receive (mid-treatment (STAI-s) 3. NS
RCT Diagnosed breast massage usual care ) 4. Distress scale: -1.6 (P=0.002)
1+ cancer, lymphoma Area: in the 2. Beck Depression Fatigue scale: -1.94 (P=0.02)
and leukemia shoulders, autologous -Final massage Inventory (BDI) Nausea scale: -1.94 (P=0.01)
USA admitted for bone neck, face and BMT (predischarge) Mean changes after fifth massage (mid-treatment):
marrow transplant scalp program 3. Brief Profile of 1. STAI-state: -7.94 (P=0.02)
(BMT) requiring - 3 massages Mood States 2. NS
high dose per week (POMS) 3: NS
chemotherapy - 3 weeks 4. NS
4. Numerical scales Mean changes after last massage (predischarge):
Massager: trained (0-10) of emotional 1. NS
healing-arts distress, fatigue, 2. NS
specialists nausea and pain 3. NS
4. Fatigue scale: -1.71 (P=0.03)
86
Table of evidence 2
Study, No. of Interventions Comparison/contr Length of follow Outcome Result/Effect size
Design, patients & ol up measures
Evidence Patients
level, characteristic
Country
2. N=39 n=19 n=20 -VAS scores of 1. VAS of 1. Mean change of VAS nausea in
Billhult, Mean age Dropout=0 Dropout=0 nausea and nausea and massage group vs mean change in control
et al., (SD)=51.8 anxiety before anxiety group:
2007 (9.3) -20 minutes -Visited by a and immediate 73.2% vs 49.5% (P=0.025)
-Sweden massage hospital staff for after each 2. The
RCT Women with with soft strokes 20 minutes with intervention Hospital No statistically significant differences in
1+ breast cancer - Either foot/lower leg unstructured Anxiety and anxiety between 2 groups.
undergoing or hand/lower arm conversation -HADS assessed Depression
Sweden chemotherap -A cold-press about any subject, before the first scale (HADS) 2. No statistically differences between
y which vegetable oil used but did not and the last groups in changed in HAD anxiety and
would be -Total 5 massage receive massage intervention depression.
given every 3 given during
weeks chemotherapy cycle 3
to 7
Massager:
nurses and
nurse’s aids
87
Table of evidence 3
Study, No. of patients & Interventions Comparison Length of follow Outcome measures Result/Effect size
Design, Patients /control up
Evidence characteristic
level,
Country
3. N=22 n=11 n=11 -Blood samples 1. Peripheral blood 1. No statistically differences on
Billhult, Mean age (SD) Dropout=0 Dropout=0 taken before the sample on the number peripheral blood concentration of NK cell
et al., =62.5 (7) first and last of NK cell and T helper and T helper cell between groups
2008 -20 minutes -20 minutes massage/control cell
Women with effleurage visit by visit 2. No statistically differences on HADS
RCT breast cancer massage hospital 2. HADS between groups
1- undergoing -either staff with -HADS and STAI
radiation therapy foot/lower leg unstructured taken prior the 3. STAI 3. No statistically differences on STAI
Sweden or hand/lower conversatio first and last between groups
Massager: trained arm n about any massage/control
registered nurses -10 times topic visit
during 3 to 4
weeks
88
Table of evidence 4
Study, No. of patients Intervention Comparison Length of Outcome Result
Design, & Patients s /control follow up measures
Evidenc characteristic (Pre/post % change in intervention vs control)
e level,
Country
4. N=34 n=18 n=16 -First day of 1. STAI 1. Significant improvement in STAI at the first and the
Hernand Mean age Dropout=0 Dropout=0 massage 2. POMS last day of massage.
ez-Reif, (SD)=53(10.4) First day : ↓ 27% vs ↓6% (P<0.01)
et al., -Swedish Receive -Last day of 3. Symptom Last day: ↓ 29% vs ↓6% (P<0.01)
2004 Women with massage standard massage Checklist-90-R
stage 1 or 2 medical (pretest of (SCL-90-R) 2. Significantly decrease at the first day of massage:
RCT breast cancer -head/neck, care outcome POMS-Depression: ↓75% vs ↓25% (P<0.01)
1++ after surgery shoulder, measures 3, 4. Urinary And POMS-Anger: ↓80% vs ↓17% (P<0.01)
back, arms 4, 5 were biochemistry
USA Massager: and performed on dopamine % change from means difference of first-last day measures
trained legs/feet before the 1st and serotonin in intervention group for the longer term effect:
massage -30 minutes day of 3. Depression ↓46% (P<0.05), Hostility ↓50% (P<0.05)
therapist -3 times per massage and 5. Serum level 4. Urine level of dopamine: ↑26% (P<0.05), serotonin ↑60%
week posttest of natural (P<0.05)
-5 weeks performed killer (NK) cell 5. Serum NK cells↑12% (P<0.05), lymphocytes ↑10%
after last day and (P<0.05)
of massage) lymphocytes
89
Table of evidence 5
Study, No. of Interventions Comparison Length of follow up Outcome measures Effect size between massage group and
Design, patients & /control control group
Evidence Patients
level, characteristic
Country
5. N= 72 n= 36 n= 36 -Baseline 1. Present pain intensity All outcome measures showed significant
Jane, et Mean age Dropout= 2 Dropout= 3 assessment on Day (PPI-VAS) improvement at measurement time points
al., 2011 (SD) = 50 1 (T0) T1, T2 and T3.
(10.6) -45 minutes -Presence of 2. Mood-VAS
RCT Female: 58% full body a caring -Pre & posttest 1. PPI-VAS: ES > 0.69 (P= 0.01)
1++ massage therapist for taken on Day 2 3. Relaxation-VAS
Cancer -3 45 minutes (T1), Day 3 (T2) 2. Mood-VAS: ES > 0.49 (P < 0.04)
Taiwan patients who consecutive (social and Day 4 (T3)
were able to sessions attention) 3. Relaxation-VAS: ES > 0.45 (P < 0.03)
speak and -Last measures on
read Chinese Relaxation-VAS &
with bone Sleep-VAS done
metastases on Day 5 (T4)
Massager:
nurses
90
Table of evidence 6
Study, No. of patients & Interventions Comparison Length of Outcome measures Result/Effect size
Design, Patients /control follow up
Evidence characteristic
level,
Country
6. N=34 n=17 n=17 T1: baseline 1. Perceived Stress 1. PSQ-worries decreased significantly in
Listing, et Mean age(SD)= Dropout=1 Dropout=4 Questionnaire (PSQ) intervention group from 37.5 (T1)to 31.3(T2)
al., 2010 59.7(11.8) -Biweekly T2: at the (P=0.047) and remain low 28.3(T3) (P=0.003)
-30 minutes Routine end of the 5 2. Berlin Mood 2. At T2, BMQ-Anger Effect size(ES) =0.82
RCT Women with Swedish health care week Questionnaire (BMQ) (P<0.05)
1+ primary breast massage to the intervention At T2, BMQ-anxious depression ES=0.90
cancer back, neck and 3. Serum cortisol and (P<0.05)
Germany head T3: 6 weeks serotonin measure At T3, BMQ-Tiredness mean difference
Massager: -5 weeks after T2 between massage and control group= -15.73
licensed, trained (P<0.05)
female massage
therapist 3. Serum cortisol level decreased significantly at
T2 (P=0.03). NS in serum serotonin level.
91
Table of evidence 7
Study, No. of Interventions Compariso Length of follow Outcome Result/Effect size
Design, patients & n/control up measures
Evidence Patients
level, characteris
Country tic
7. N=230 -4 weekly Standard - Outcome 1. Heart rate, 1. MT and HT reduced respiratory rate (P<0.001),
Post-White, Mean age -45 minutes care measures 1& 2 respiratory rate heart rate (P<0.001) and systolic (P<0.001) and
et al., 2003 (SD) = A: Therapeutic were measure and blood diastolic pressure (P<0.001)
54.7(11.7) massage (MT) (crossover before and after pressure 2. MT (P<0.001) and HT (P<0.011) have
RCT n=78 from each significantly lower in pain level. There is no
(crossover) Female: -Swedish massage interventio intervention. 2. 0-10 scale of significantly different in nausea scale in MT and HT.
1+ 86.1% on whole body n groups) - Outcome current pain and 3. NS
Adult with massage gel measures 3, 4, 5 current nausea 4. NS
USA out-patient B: Healing touch measures before Mean of MT at session 1→4 vs control at session
s receiving (HT) session 1 and 3. Brief Pain 1→4:
chemother n=77 each 4-week Index (BPI) 5. POMS-Mood disturbance: 32.9→17.8 vs
apy C: Caring crossover period 31.0→29.6 (P=0.004)
Massager: presence (P) session 4, 5, 8. 4. Brief Nausea POMS-Anxiety: 11.1→7.6 vs 10.8→9.6 (P=0.02)
Registered n=75 Index (BNI) HT reduced total mood disturbance (P=0.003) and
nurses fatigue (P=0.028)
5. POMS Presence had no different than control in POMS
measures.
92
Table of evidence 8
Study, No. of Interventions Compari Length of Outcome measures Result/Effect size
Design, patients & son/contr follow up
Evidenc Patients ol
e level, characteristi
Country c
8. N=183 Intervention Intervent - Primary 1st outcome: Means difference at primary end-point:
Sharp, et A: n=60 ion C: end-point: 18 1. The Trial Outcome 1. Intervention B has significant improvement on
al., 2010 Mean age Dropout=3 n=62 weeks after Index (TOI): TOI: 4.01 (P=0.03)
(SD)= reflexology dropout= surgery (4 composed of the sum 2. Both intervention A and B have significant
RCT 58.78 on foot plus 11 week after of scores on the improvement in MRS-relaxation:
1++ (10.31) usual care Usual last massage) physical, functional Intervention A-C: 26.92 (P≦0.0005)
Breast Intervention care and breast cancer Intervention B-C: 26.21 (P≦0.0005)
UK cancer B: n=61 Secondary concern subscales. Intervention B has significant improvement in
nd
female 6 Dropout=3 end-point: 24 2 outcome: MRS-easy goingness:
weeks post Scalp weeks after 2. Mood Rating Scale Intervention B-control: 24.8 (P≦0.0005)
breast massage plus surgery (10 (MRS) 3. NS
surgery usual care week after 3. HADS Means difference at secondary end-point:
last massage) 1. Intervention A has significant improvement on
Massager: -1 hour TOI: 5.4 (P=0.02)
not mention session 2. Intervention A has significant improvement on
- Weekly MRS-relaxation: 18.23 (P=0.02)
-8 weeks 3. NS
93
Table of evidence 9
Study, No. of Interventions Comparison Length of Outcome measures Result/
Design, patients & / control follow up Effect size
Evidence Patients
level, characteristic
Country
9. N=42 - 30 minutes Usual care Weekly 1st outcome: 1. Statistically improvement on the mean
Soden, et Aged:44-85 - Back N=13 after every 1. Visual Analogue Scale change in pain VAS scores compared
al., 2004 years massage massage (VAS) of pain intensity with baseline in second massage: AT:
Median: 73 - Weekly Did not -1.15 (P=0.01)
RCT years - 4 week receive any 2nd outcome:
1- Female: 76% Aromatherapy massage 2. HADS 2. MT have significant improvement on
Dropout: 6 group: (AT) n= during the median HAD scores in second and fourth
UK 16 massage study period treatments:
All kind of with lavender 2nd week: -2.0 (P≦0.05)
cancer essential oil 4th week: -1.5 (P≦0.01)
diagnosis Massage
Metastatic group: (MT)
disease: 55% n= 13 massage
with inert
Massager: carrier oil
not Massager: not
mentioned mentioned.
94
Appendix H: Table of summary for the studies’ results
Citations Level of Participants Mean age Area of massage Duration Frequency Massager Follow-up Outcome Results
evidence (Sample size) (SD) measures
1. Ahles, et al., 1+ BMT 41 Swedish on 20 min 3/week, Trained healing arts 1st, 5th & final STAI-s Improve STAI-s
st th
1999 USA N=34 (9.3) shoulders, neck, face 3 wks specialists massage after 1 and 5
and scalp massage
2. Billhult, et 1+ Breast cancer 51.8 Swedish on either 20 min Q3wks, Nurses VAS: Before and after HADS Improve in
al., 2007 Sweden female on (9.3) foot/lower leg or on cycle 3-7 each massage Anxiety and VAS-nausea
chemo hand/lower arm HADS: before the 1st Nausea-VAS
N=39 and after last massage
3. Bullhult, et 1- Breast cancer 62.5 Swedish on either 20 min 10 time Nurses Before the 1st and after HADS No significant
al., 2008 Sweden female in RT (7) foot/lower leg or during 3-4 the last massage STAI improvement
N=22 hand/lower arm wks
4. Hernandez, 1++ Breast cancer 53 Swedish on head/ 30 min 3/week, Trained massage 1st and last day of STAI-s Improve STAI-s in
et al., 2004 USA female (10.4) neck, shoulder, back, 5 wks therapists massage both follow up
N=34 arms, leg/feet
95
Citations Level of Participants Mean age Area of massage Duration Frequency Massager Follow-up Outcome Results
evidence (Sample size) (SD) measures
5. Jane, et al., 1++ Cancer patient 50 Swedish on whole 45min 3 consecutive Nurses Baseline: day 1 VAS-Mood Improve mood and
2011 Taiwan with bone met (10.6) body session Mood-VAS: Day 2, 3, 4 VAS-Relaxation relaxation on day 2,
N=72 Relaxation-VAS: Day 5 3, 4.
6. Listing, et 1+ Breast cancer 59.7 Swedish on back, 30 min Biweekly, Licensed trained Baseline, at the end BMQ-anxious Improve BMQ-
al., 2010 Germany female (11.8) neck and hand 5 wks massage therapists and 6 wk after final depression anxious depression at
N=34 massage the end of massage
7. Post-White, 1+ Chemo pt 54.7 Swedish on whole 45 min Weekly, Nurses Before 1st and after POMS-anxiety Improve POMS-
et al., 2003 USA N=230 (11.7) body 4 wks 4th massage subscale anxiety
8. Sharp, et al., 1++ Breast cancer 58.78 Scalp 1 hr Weekly, Not mentioned 4 week and 10 week HADS Improve MRS-
2010 UK female (10.31) 8 wks after last massage MRS-relaxation relaxation score after
N=183 subscale 4 weeks
9. Soden, et al., 1- All cancer Median: Back 30 min Weekly, Not mentioned Weekly HADS Improve in
2004 UK N=42 73 4 wks HADS-depression on
nd th
2 & 4 week
96
Appendix I:
anti-emetics
Anti-emetics Dosage Frequency #Cost for 1 day Duration Cost for 3 days per patient
day = $142.8
day = $40
# the price of medication is based on the Drug formulary at the Hospital Authority.
The average costs of taking these drugs for 3 days per patient:
($190.5+$428.4+$120)/3 = $246.3
Assuming 20% of total patients (233 patients) joining the program per year do
not require the use of these potent anti-emetics after receiving massage,
97
Appendix J
Training
Running cost
Printed materials:
Consent
Total patients admitted to the day ward in the past year 11,692
98
Appendix K: Grade of recommendation
99
Appendix L
Introduction
side effects including nausea, anxiety, impairing their quality of life. A study
(Molassiotis, et al., 2002) showed that there were 15-40% cancer patients suffering
The use of massage for cancer patients receiving chemotherapy can greatly improve
their anxiety, mood status and severity of nausea and vomiting, hence, improving
their quality of life (Corbin, 2005). The following evidence-based practice (EBP)
guideline is developed for the use of massage on adult cancer patients receiving
chemotherapy to reduce anxiety in the chemotherapy day ward. This EBP guideline is
developed based on the evidence generated from nine RCTs. The recommendation
and the level of evidence are graded according to the Scottish Intercollegiate
Aim
Objectives
100
Target population
The massage therapy is applicable to both male and female adult cancer patients
Inclusive criteria
- Aged 18 or above
- Cognitively competent
Exclusive criteria
- Coagulation disorder
- Venous thrombosis
- Bone metastasis
- Peripheral neuropathy
- Radiation dermatitis
(Recommendation 1.0)
1. Introduce and explain the massage program to potential patients and give a
2. Seek oncologist’s approval for the selected patient to receive massage therapy
3. Reconfirm eligibility of patient during the next admission to day ward for
101
4. Ask patient to complete the State-Trait Anxiety Inventory (STAI) assessment
form on admission and after receiving the massage to measure patient’s level of
5. Check patient’s vital signs including blood pressure, pulse, respiratory rate and
oxygen saturation and document in the assessment form before and after the
massage intervention.
massage therapy.
9. Monitor and manage patients with massage-induced complications (see Table 1).
I. Strokes from the ventral side of the foot up around the knee and back to the
foot.
II. Small circular movements and kneading on the side of the calf from the foot
to the knee.
102
III. Circular stroking around the sides of the knee and the ankle.
VI. Strokes from the ventral side of the foot up around the knee and back to the
foot.
103
Evidence of the recommendations
Recommendation 1.0
open wound over lower limbs are excluded from receiving massage in four of the
reviewed RCTs(Hernandez-Reif, et al., 2004; Jane, et al., 2011; Sharp, et al., 2010;
Listing, et al., 2010). This is necessary as these conditions may heighten the risk of
Jane, et al., 2011; Sharp, et al., 2010; Listing, et al., 2010) (1++; 1++; 1++; 1+).
Recommendation 2.0
recommendation: A)
embolism were reported from participants in seven reviewed RCTs which used
Swedish massage as their interventions. (Ahles, et al., 1999; Billhult, et al., 2007;
Billhult, et al., 2008; Hernandez-Reif, et al., 2004; Jane, et al., 2011; Listing, et al.,
2010; Post-White, et al., 2003). (1+; 1+; 1-; 1++; 1++; 1+; 1+)
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Recommendation 3.0
recommendation: A)
Six reviewed studies used 20-30 minute massage and five of them reported to
have positive effects in reducing level of anxiety and sense of nausea for cancer
patients (Ahles, et al., Billhult, et al., 2007; Billhult, et al., 2008; Hernandez-Reif, et
al., 2004; Listing, et al., 2010; Soden, et al., 2004). The immediate short-term (30 min)
benefits of massage therapy is well proved to reduce anxiety for cancer patients
(Hernandez-Reif, et al., 2004; Listing, et al., 2010; Soden et al., 2004). (1++; 1+; 1- )
Recommendation 4.0
measure the patient’s level of anxiety before and after the massage so as to
A)
Five reviewed RCTs used one-dimensional self assessment tools to measure the
subjective feeling of anxiety for cancer patients (Ahles, et al., 1999; Billhult, et al.,
2007; Bullhult, et al., 2008; Hernandez-Reif, et al., 2004; Jane, et al., 2011). Three of
them used STAI-S assessment tool to measure anxiety level for cancer patients and
resulted in decrease in their anxiety level (Ahles, et al., 1999; Billhult, et al., 2008;
assessment tool that is short and easy for cancer patients to complete. (1+; 1-; 1++)
105
Table 1. Potential massage-induced complications, manifestations and
management
106
Table 2. Step of massage
knee.
107
Reference of the guideline:
1. Ahles, T. A., Tope, D. M., Pinkson, B., Walch, S., Hann, D., Whedon, M., Dain,
B., Weiss, J. E., Mills, L.& Silberfarb, P. M. (1999). Massage Therapy for
in Women with Breast Cancer Who Are Undergoing Chemotherapy. The Journal
4. Hernandez-Reif, M., Ironson, G., Field, T., Hurley, J., Katz, G., Diego, M., Weiss,
S., Fletcher, M. A., Schanberg, S., Kuhn, C. & Burman, I. (2004). Breast cancer
5. Jane, S. W., Chen, S. L., Wilkie, D. J., Lin, Y. C., Foreman, S. W., Beaton, R. D.,
Fan, J. Y., Lu, M. Y., Wang, Y. Y., Lin, Y. H. & Liao, M. N. (2011). Effects of
massage on pain, mood status, relaxation, and sleep in Taiwese patients with
6. Listing, M., Krohn, M., Liezmann, C., Kim, I., Reisshauer, A., Peters, E., Klapp,
108
7. Post-White, J., Kinney, M. E., Savik, K., Gau, J. B., Wilcox, C. & Lerner, I.
8. Sharp, D. M., Walker, M. B., Chaturvedi, A., Upadhyay, S., Hamid, A., Walker,
A. A., Bateman, J., Braid, F., Ellwood, K., Hebblewhite, C., Hope, T., Lines, M.
312-322.
9. Soden, K., Vincent, K., Craske, S., Lucas, C. & Ashley, S. (2004). A randomized
18, 87-92.
109
Appendix M: Timetable for implementation of the massage program
Sep 2013 Oct 2013 Nov 2013 Dec 2013 Jan 2014 to Jun 2014 Jul 2014 Aug 2014
1. Forming a team of core members
2. Seeking administrator’s approval
3. Refining the guideline
4. Training to nurses and volunteers
5. Pilot study
6. Amending guideline and logistics of
the program
7. Implementing the program
8. Evaluating the outcome
9. Generating report and disseminating
the finding
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Appendix N
Gum label
Assessment form for the massage program
Part 1
*********************************************************************
Part 2
Medical assessment
(Completed by oncologists during patient’s follow-up)
No Yes Remarks
1. Does the patient have coagulation disorder?
2. Does the patient have history of spinal cord injury?
3. Does the patient have history of thrombosis?
4. Does the patient have bone metastasis?
5. Does the patient experience chemotherapy-induced
peripheral neuropathy?
*********************************************************************
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Assessment form for massage program Page. 2
**********************************************************
Part 3
Nursing integrated assessment
(Complete by nurses on the same day of massage)
Blood Result:
Platelet count:
Clotting:
以下是一般人常用來描述自己感受的句子,請仔細閱讀每一句,然後根據你現在的感受 (即此時
此刻的感受),圈選一個最適當的答案。
完 有 頗 極
全 些 為 為
不
符 符 符 符
合 合 合 合
1 我現在覺得心裡平靜 # 1 2 3 4
2 我現在覺得安全 # 1 2 3 4
3 我現在是緊繃的 1 2 3 4
4 我現在覺得很緊張 1 2 3 4
5 我現在覺得很放鬆 # 1 2 3 4
6 我感到困擾 1 2 3 4
7 我現在正擔心可能將有不幸的事會發生 1 2 3 4
8 我現在覺醒很滿意 # 1 2 3 4
9 我現在覺得害怕 1 2 3 4
10 我現在覺得心裡舒適 # 1 2 3 4
11 我覺得我是自信的 # 1 2 3 4
12 我覺得我很神經質 1 2 3 4
13 我常常是戰戰兢兢的 1 2 3 4
14 我覺得自己優柔寡斷 1 2 3 4
15 我現在是放鬆的 # 1 2 3 4
16 我現在覺得很滿足 # 1 2 3 4
17 我現在是憂慮的 1 2 3 4
18 我現在覺得困惑 1 2 3 4
19 我現在覺得穩定 # 1 2 3 4
20 我現在覺得很愉快 # 1 2 3 4
# 為反向計分
********************************************************************
113
Assessment form for massage program Part 5 Page. 4
按摩後評估 Post-massage measurement form(由病人填寫)
(一) 情景特質焦慮量表-情境焦慮部分 (STAI-S)
以下是一般人常用來描述自己感受的句子,請仔細閱讀每一句,然後根據你現在的感受 (即此時
此刻的感受),圈選一個最適當的答案。
完 有 頗 極
全 些 為 為
不
符 符 符 符
合 合 合 合
1 我現在覺得心裡平靜 # 1 2 3 4
2 我現在覺得安全 # 1 2 3 4
3 我現在是緊繃的 1 2 3 4
4 我現在覺得很緊張 1 2 3 4
5 我現在覺得很放鬆 # 1 2 3 4
6 我感到困擾 1 2 3 4
7 我現在正擔心可能將有不幸的事會發生 1 2 3 4
8 我現在覺醒很滿意 # 1 2 3 4
9 我現在覺得害怕 1 2 3 4
10 我現在覺得心裡舒適 # 1 2 3 4
11 我覺得我是自信的 # 1 2 3 4
12 我覺得我很神經質 1 2 3 4
13 我常常是戰戰兢兢的 1 2 3 4
14 我覺得自己優柔寡斷 1 2 3 4
15 我現在是放鬆的 # 1 2 3 4
16 我現在覺得很滿足 # 1 2 3 4
17 我現在是憂慮的 1 2 3 4
18 我現在覺得困惑 1 2 3 4
19 我現在覺得穩定 # 1 2 3 4
20 我現在覺得很愉快 # 1 2 3 4
# 為反向計分
********************************************************************
114
Assessment form for massage program Part 5 Page. 5
按摩前 (0 分鐘):
開始按摩後 (15 分鐘):
開始按摩後 (30 分鐘):
按摩前 (0 分鐘):
開始按摩後 (15 分鐘):
開始按摩後 (30 分鐘):
~問卷完~
~多謝參與~
115