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 Psychological interventions for women with non-metastatic
breast cancer (Protocol)

Jassim GA, Whitford DL, Grey IM

This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane
Library 2010, Issue 10
http://www.thecochranelibrary.com

Psychological interventions for women with non-metastatic breast cancer (Protocol)

Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Psychological interventions for women with non-metastatic breast cancer (Protocol) i

Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Protocol]

Psychological interventions for women with non-metastatic

breast cancer

Ghufran A Jassim1 , David L Whitford2 , Ian M Grey3

1 Family
and Community Department, Royal College of Surgeons in Ireland, Medical University of Bahrain, Adliya-Bahrain, Bahrain.
2 Family
and Community Health, Royal College of Surgeons in Ireland, Medical University of Bahrain, Adliya, Bahrain. 3 Psychology,
Royal College of Surgeons in Ireland, Medical University of Bahrain, Manama, Bahrain

Contact address: Ghufran A Jassim, Family and Community Department, Royal College of Surgeons in Ireland, Medical University
of Bahrain, Adliya-Bahrain, Bahrain. gjassim@rcsi-mub.com.

Editorial group: Cochrane Breast Cancer Group.

Publication status and date: New, published in Issue 10, 2010.

Citation: Jassim GA, Whitford DL, Grey IM. Psychological interventions for women with non-metastatic breast cancer. Cochrane
Database of Systematic Reviews 2010, Issue 10. Art. No.: CD008729. DOI: 10.1002/14651858.CD008729.

Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
To determine the effectiveness of psychological interventions on psychological morbidities, QoL and survival among women with non-
metastatic breast cancer.

Psychological interventions for women with non-metastatic breast cancer (Protocol) 1

Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
BACKGROUND
A review of 37 studies on the epidemiology of major depression
in women with breast cancer suggested a rate of 10% to 25%
Description of the condition (Fann 2008). In a large cohort of 4496 patients with cancer, the
prevalence of depression in breast cancer was estimated to be
Breast cancer is the most common cancer in women of all ages.
around 52% (Zabora 2001). This wide variation in rates of psy-
About 1.3 million women will be diagnosed with breast cancer
chological disorders may be attributed to methodological differ-
every year worldwide and about 465,000 will die from the disease
ences across studies, different characteristics of the groups studied,
making it the third leading cause of death in women, after heart
heterogeneous tumour stage and stage at which assessment took
disease and lung cancer (ACS 2009). Improved prevention and
place in relation to diagnosis or treatment. Moreover, the use of
detection methods, as well as advances in medical treatment, have
different diagnostic criteria for depression and anxiety may have
resulted in a trend toward increasing numbers of cancer survivors (
contributed to the different rates reported in the above studies
ACS 2009). Survival gains achieved in breast cancer have produced
(Chochinov 1994). Predictors of psychological morbidity follow-
a growing acceptance of breast cancer as a long term illness and
ing breast cancer diagnosis and treatment were primarily related
have led to a greater emphasis on rehabilitation and subsequently
to the patient (namely younger age, previous psychological prob-
the quality of life (QoL) of these women (Reynolds 2000).
lems and a lack of social support) rather than to the disease or
However, breast cancer is still a distressing diagnosis and, as a
treatment (Burgess 2005). Socio-economically deprived patients
result, considerable research has examined the psychological se-
were also at risk of depression at three to four months after surgery
quelae of being diagnosed and treated for breast cancer. In line
(Christensen 2009). Adujuvant chemotherapy was found to in-
with the increasing adoption of a bio-psychosocial model of health
crease the risk of depression, anxiety or both during but not after
care, one focus of interest has been to determine whether a di-
treatment (Burgess 2005). These side-effects varied depending on
agnosis of breast cancer is associated with specific psychologi-
the specific agents used in the adjuvant regimen as well as the dose
cal disorders and what course these take in patients (Fann 2008;
and duration of treatment (Boehmke 2005).
Okamura 2005; Reich 2008). Psychological morbidities such as
One quarter of women maintained clinically significant levels of
anxiety, depression, stress, distress, difficulty in adjustment and
distress over a 12-month period (Millar 2005). Distress emerged
decreased social interactions (Vos 2006) are common responses
or intensified when women expected symptoms to disappear but
to the diagnosis and treatment of breast cancer. Such responses
they continued to persist (Rosedale 2010). However, what is the
may arise from pain (Reddick 2005), fear of recurrence, treatment
most intense or frequently occurring symptom is not necessarily
side-effects, life stresses (Low 2006) and lymphedema (McWayne
the most distressing to patients (Bárez 2009; Henselmans 2009).
2005). Many women consider chemotherapy as the most distress-
Most research has focused on the identification of predictive vari-
ing aspect of treatment as it is usually associated with unpleasant
ables related to higher levels of symptom distress such as age (Baider
symptoms such as nausea, emesis, fatigue and alopecia (Boehmke
2003), coping style (Ben-Zur 2001), base-line anxiety and depres-
2005; Partridge 2001). This debilitating effect is more profound
sion, and fear of recurrence (Lebel 2009). When compared to a co-
in younger women who also experience the sudden onset of early
hort of matched women free of disease, women with breast cancer
menopause with the attendant symptoms of hot flashes, decreased
exhibited significantly higher distress and different coping styles
sexual desire and vaginal dryness (Baucom 2005; Partridge 2004).
from their counterparts in the control group (Amir 2002).
Notably, younger women may have specific fertility needs and
In addition to specific psychological disorders such as anxiety and
concerns (Peate 2009).
depression, over the last two decades QoL outcomes have been
The considerable data available in relation to psychological condi-
increasingly used as an outcome variable in breast cancer research
tions associated with breast cancer suggest that depression and anx-
(Hewitt 2004). These studies have collectively examined QoL out-
iety are the most commonly studied mood disorders (Fann 2008).
comes for women diagnosed at different ages, various stages of
Rates of major depression or anxiety in breast cancer patients have
the disease and at different time intervals between diagnosis and
been estimated to range from 20% to 30% in the initial six months
treatment (Ganz 2002). Most, but not all, data suggest that a
following breast cancer diagnosis in women with early stage breast
younger age and shorter duration of time from diagnosis are asso-
cancer (Akechi 2001; Fallowfield 1990). However, a recent study
ciated with poorer QoL (Ganz 2002; Mols 2005). Social support
suggests that the number of patients approaching threshold for de-
from family members and friends helps to decrease the negative
pressive and anxiety disorders (including borderline cases) is close
effects of symptoms on QoL (Ashing-Giwa 2009; Kulik 2005;
to 50% in the first year after diagnosis, dropping rapidly in the
Manning-Walsh 2005) and improve women’s adjustment and abil-
second year to 25% and sustaining a further gradual decrease over
ity to cope (Bloom 1982). Social deprivation was also related to
the five-year study period to 15% in the fifth year (Burgess 2005).
poor breast cancer prognosis (Vona-Davis 2009).
On the other hand, results from the UK Standardisation of Radia-
In addition to the impact on psychological disorders and QoL,
tion Therapy Trials (START) showed that about one third (35%)
it has been suggested that psychological distress following breast
of women reported anxiety or depression, or both; which did not
cancer diagnosis and treatment may also adversely affect sur-
significantly change over five years of follow up (Hopwood 2010).

Psychological interventions for women with non-metastatic breast cancer (Protocol) 2

Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
vival (Spiegel 1989), although this latter outcome is controversial sources and coping skills are reinforced in order to avoid relapse
(Smedslund 2004). Moreover, fighting spirit was linked to recur- and for them to contribute to their own health and wellness on a
rence-free survival in one of the pioneering studies in this field long term basis. The theory considers that the better knowledge
(Greer 1979). the patient has of her illness, the better the patient can live with
As a consequence of the effects of breast cancer on depression, her condition.
anxiety and QoL, various psychological interventions have been
utilised to help address the psychological distress experienced after
a diagnosis of breast cancer. This systematic review seeks to assess
the effectiveness of those therapies which have thus far been sub- How the intervention might work
jected to controlled trials. The purpose of psychological support programmes in breast can-
cer is to promote awareness and education, provide emotional
support and assist women with problem solving so that they can
Description of the intervention go through the processes and cope better with cancer (Sandgren
2000). It has been suggested that understanding the uncertainty
Psychological intervention includes a wide range of therapeutic
experienced plays a key role in positively influencing future be-
techniques and is poorly defined in the literature.
haviours (Montgomery 2010). For example, CBT was the most
Cognitive behavioural therapy (CBT) is a psychotherapeutic ap-
frequently used approach in studying the effect of psychological
proach that aims to solve problems concerning dysfunctional cog-
intervention in cancer patients (Moyer 2009; Redd 2001) and has
nition, emotions and behaviours through a goal-oriented system-
been shown to be a valuable tool in relieving distress in various
atic procedure. CBT includes a variety of approaches and therapeu-
cancer populations (Mundy 2003), particularly amongst breast
tic systems; some of the most well known include cognitive ther-
cancer patients (Tatrow 2006).
apy, rational emotive behaviour therapy and multimodal therapy.
CBT focuses on changing specific thoughts or behaviours or on
learning specific coping skills (Hopko 2008), such as progressive
muscle relaxation training, meditation, hypnotherapy, systematic Why it is important to do this review
desensitisation, biofeedback, behaviour modification or reinforce-
There is a cumulating amount of research concerned with the
ment and cognitive therapy. In the past decade, research has sup-
effects of psychological interventions on QoL and psychological
ported mindfulness-based therapies such as meditation for a num-
morbidity in women with non-metastatic or early stage breast can-
ber of medical and psychiatric conditions accompanying breast
cer. Yet the strength of this relationship is unknown because stud-
cancer diagnosis and treatment (Carlson 2003; Lengacher 2009).
ies have not been combined into a systematic review. Several items
In recent years, CBT therapists have witnessed a shift towards fo-
pertaining to psychological interventions in early stage breast can-
cused therapies such as Acceptance and Commitment Therapy
cer remain unresolved; for instance which interventions work the
(ACT) (Dahl 2004).
best, for which patient and other items related to the therapy (for
Psychotherapy, or personal counselling with a psychotherapist,
example duration, dose, type and optimal time to start therapy).
is an intentional interpersonal relationship used by trained psy-
Hence, the true effect of psychological interventions on the QoL
chotherapists to aid a client or patient in problems of living. It in-
of women with non-metastatic breast cancer remains unclear.
cludes non-directive, psychodynamic, existential, supportive, gen-
A previous review of psychological intervention was conducted
eral or crisis intervention; no specific behavioural or coping skills
on women with metastatic breast cancer, which limited the ap-
are taught (Barsevick 2002).
plicability of the review to a larger entity of women with non-
Group psychotherapy or group therapy is a form of psychotherapy
metastatic breast cancer (Edwards 2008). Indeed one might ques-
in which one or more therapists treat a small group of clients. The
tion whether women with non-metastatic breast cancer have dif-
term can legitimately refer to any form of psychotherapy when
ferent outcomes to those women with metastatic breast cancer,
delivered to a group, including CBT or interpersonal therapy, but
especially as early detection and treatment continues to improve
it is usually applied in the context of psychodynamic group therapy
and patients continue to live longer.
where the group process explicitly uses mechanisms of change by
developing, exploring and examining interpersonal relationships
within the group.
Psycho-educational intervention is the education offered to people
who live with a psychological disturbance. Frequently, psycho-ed- OBJECTIVES
ucational training involves patient training courses in the context
of treating a physical illness. Family members are also included in To determine the effectiveness of psychological interventions on
the education. A goal is for the patient to understand and deal psychological morbidities, QoL and survival among women with
with the presenting illness. Also, the patients’ own strengths, re- non-metastatic breast cancer.

Psychological interventions for women with non-metastatic breast cancer (Protocol) 3

Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
METHODS
Criteria for considering studies for this review
Types of studies
Randomised controlled trials which compare any form of psycho-
logical or behavioural intervention with placebo, waiting list con-
trol or an alternative form of psychological intervention.
Types of participants
Women with a histologically confirmed diagnosis of breast car-
cinoma of early non-metastatic stage (Grade I-III) as defined by
the American Joint Committee on Cancer (AJCC) TNM system
(American Joint Committee 2009).
The following studies will be excluded:
• studies including women with distant metastasis (grade IV)
unless there are subgroup analyses.
• studies including patients with other types of cancer unless
there are subgroup analyses of breast cancer groups.
• studies about psychological intervention in caregivers of
women with breast cancer as they represent a different entity.
Types of interventions
A range of psychological interventions to prevent or treat psycho-
logical distress will be eligible for inclusion:
• cognitive behavioral techniques;
• psychotherapy or counselling; and
• psycho-educational interventions.
We will compare these interventions to an inactive control inter-
vention (that is placebo, standard care or waiting list control) or
with an active control intervention (for example another form of
psychological intervention).
Studies with multi-interventions will be excluded unless data are
extractable.
Types of outcome measures
Primary outcomes
• Quality of life (QoL) following psychological intervention
(assessed using any validated generic or disease-specific
questionnaire).
• Rates of depression and anxiety following psychological
intervention (assessed using any validated generic or disease
specific tool).
• Stress, distress, coping and adjustment (assessed using any
validated generic or disease specific tool).
• Survival.
Psychological interventions for women with non-metastatic breast cancer (Protocol)
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
For some people psychological intervention may be overwhelming
and these people may suffer initial adverse effects such as increased
stress following therapy (Bisson 2007). Therefore, we will also
record any reported adverse events related to the psychological
intervention.
Search methods for identification of studies
See: Breast Cancer Group methods used in reviews.
There are no language limits. Articles in all languages will be
searched and relevant abstracts will be translated.
Electronic searches
We will search the following databases.
(a) The Cochrane Breast Cancer Specialised Register main-
tained by the Cochrane Breast Cancer Group (CBCG). De-
tails of the search strategies used by the CBCG for the iden-
tification of studies and the procedure used to code references
are outlined in their module (www.mrw.interscience.wiley.com/
cochrane/clabout/articles/BREASTCA/frame.html). Trials coded
with the key words ’psychological intervention’ and ’early breast
cancer’ will be extracted for consideration.
(b) The Cochrane Central Register of Controlled Trials (CEN-
TRAL) (The Cochrane Library, current Issue).
(c) MEDLINE (via PubMed) (July 2008 to 2010).
(d) EMBASE (via embase.com) (2008 to 2010).
(e) PsycINFO (1960 to 2010)
(f ) IndMED (1985 to 2010)
(g) Iranmedex (1989 to 2010)
(h) PsycLit (1973 to 2010).
(i) CancerLit (1975 to 2010).
(j) CINAHL (1982 to 2010).
(k) The WHO International Clinical Trials Registry Platform (IC-
TRP) search portal (http://apps.who.int/trialsearch/Default.aspx)
for all prospectively registered and ongoing trials.
Searches will be initially undertaken using key words then fol-
lowed by searches of related articles until previously selected papers
are obtained. Key words to be used are: breast cancer, breast neo-
plasm, quality of life, well-being, depression, anxiety, stress, dis-
tress, adjustment, coping, mental health, health-related quality of
life, psychological intervention, psychological morbidity, psychi-
atric morbidity, cognitive behavioral therapy, group psychother-
apy, relaxation, supportive therapy, visual imagery and psychoso-
cial intervention.
Searching other resources
Searches will also include the following.
(a) Bibliography searching. The bibliographies of all included stud-
ies and review papers will be searched in order to identify other
potentially suitable studies. Articles cited by relevant studies will
4
be reviewed. Language restrictions will not be imposed. Full trans-
lations of all non-English language papers will be conducted using
local resources.
(b) Unpublished literature. Experts in this field will be contacted.
Letters will be sent to all authors of included studies requesting
information on unpublished data or ongoing studies.
(c) Handsearching of journals. A list of journals currently be-
ing handsearched by The Cochrane Collaboration is available at
the US Cochrane Center Handsearch master list page (http://
apps1.jhsph.edu/cochrane/masterlist.asp).
Data collection and analysis
Selection of studies
Two authors (GJ and DW) will independently assess the titles and
abstracts of each identified trial for inclusion into the review. After
the initial assessment, we will obtain full versions of all potentially
relevant articles. A third author (IG) will be approached to resolve
any discrepancies regarding eligibility.
If the results of a randomised controlled trial (RCT) have not
been published and three authors (GJ, DW and IG) are satisfied
with the quality of the data, data will be included (where possible)
and disclosed in the discussion section. Trials will be included if
randomisation and patient preference allocation arms analysis are
performed. If this analysis is not completed, the trials will be dealt
with separately because of the risk of allocation bias.
Additional data or information will be sought from the principal
investigator of the trial concerned, where necessary.
Data extraction and management
Data from all relevant studies will be extracted and entered into the
’Characteristics of included studies’ table in RevMan 5 (RevMan
2008). All studies will be appraised independently by all review
authors (GJ, DW, IG). Any disagreement will be resolved by dis-
cussion. Extracted data will include the following.
(a) Participants: country of origin, sample size, setting, diagnostic
criteria, age, ethnicity, date of study and data on baseline psycho-
logical morbidity for assessment of effect modifiers.
(b) Methods: study design, methods of allocation, allocation se-
quence concealment, blinding, exclusion of participants after ran-
domisation, proportion and reasons for loss at follow up.
(c) Interventions: type, dose, length and frequency of intervention
(for each intervention and comparison group).
(d) Outcomes: primary and secondary outcomes using validated
instruments will be reported as explained in the ’Types of outcome
measures’ section of the protocol.
If mentioned, sources of funding will be recorded in the ’Charac-
teristics of included studies’.
Psychological interventions for women with non-metastatic breast cancer (Protocol)
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Assessment of risk of bias in included studies
All review authors will grade and assess each selected trial using
a simple contingency form, addressing the six specific domains
discussed in the Cochrane Handbook for Systematic Reviews of In-
terventions 5.0.0 (Higgins 2008). Grades given by all authors will
be compared and any inconsistencies and disagreements will be
resolved by discussion. Each domain will be assigned a judgment
related to the risk of bias in that domain. A judgment of ’Yes’ indi-
cates a low risk of bias, ’No’ indicates a high risk of bias, and ’un-
clear’ indicates unclear or an unknown risk of bias. The domains
are:
1. sequence generation;
2. allocation concealment;
3. blinding of participants, personnel and outcome assessors;
4. incomplete outcome data;
5. selective outcome reporting; and
6. other sources of bias.
Assessment of these domains for each trial will be reported in the
’Risk of bias in included studies’ table.
Measures of treatment effect
The data could be continuous (for example changes in depres-
sion scales), dichotomous (for example either depressed or not
depressed), ordinal (for example categories on a QoL scale such
as mild, moderate and severe) or time-to-event data (for example
survival data).
Decisions regarding if and how to combine these outcomes will be
made depending on how the the data are collected by each trial.
This decision will be guided by section 9.2 ’Types of data and
effect measures’ in the Cochrane Handbook for Systematic Reviews
of Interventions 5.0.0 (Higgins 2008).
If presented with continuous data, the mean and standard devia-
tion will be reported if possible (that is when the outcome mea-
surements in all studies are made on the same scale). Data from
studies that assess the same outcome but measure it in a variety of
ways using different scales will be meta-analysed using the stan-
dardised mean difference.
If presented with dichotomous data and the authors have specified
a cut-off point for determining clinical effectiveness, we will use
this where appropriate. Otherwise, cut-off points on rating scales
will be identified and participants will be divided on the basis of
whether they are clinically improved or not clinically improved.
For dichotomous outcomes, a Mentel-Haenszel odd ratio with its
associated 95% confidence interval (CI) will be estimated.
If presented with ordinal data, longer ordinal scales will be analysed
as continuous data while shorter ordinal scales will be made into
dichotomous data by combining adjacent categories. The latter
is especially appropriate if an established, defensible cut-point is
available (Higgins 2008).
In the case of time-to-event data, intervention effects will be ex-
pressed as hazard ratios.
5
Unit of analysis issues
We expect that some studies may present their results at several
time periods for follow up (for example six months, one year and
two years). Therefore, three periods of follow up will be identified.
Time frames are defined to reflect short term (up to six months),
medium term (six to 12 months) and long term follow up (more
than 12 months).
Dealing with missing data
Every effort will be made to retrieve missing data for all included
trials from the investigators and if unsuccessful, a narrative syn-
thesis of the data will be provided and discussed in the context of
the findings.
Assessment of heterogeneity
To check for statistical heterogeneity between studies, both the I2
statistic and Chi2 test of heterogeneity as well as visual inspection
of the forest plots will be used. The graphical representation of
the data will be inspected; if confidence intervals for the results
of individual studies have poor overlap, it generally indicates the
presence of statistical heterogeneity. In addition, the Chi2 test will
be performed to check for differences between the results of each
included trial. A P value of 0.10, rather than the conventional
level of 0.05, will be used to determine the statistical significance.
A low P value provides evidence of heterogeneity of intervention
effects (Higgins 2008). The I2 statistic will be used to quantify
inconsistency across studies.
Assessment of reporting biases
We will follow the recommendations on testing for funnel plot
asymmetry as described in section 10.4.3.1 of the Cochrane Hand-
book for Systematic Reviews of Interventions 5.0.0 (Higgins 2008).
Funnel plot asymmetry may be due to reporting bias and we will
address this possibility in the ’Discussion’, if appropriate.
Data synthesis
We will seek statistical support from the Cochrane Breast Cancer
Review Group. One review author (GJ) will analyse the extracted
data and report them as mentioned in Chapter 9 of the Cochrane
Psychological interventions for women with non-metastatic breast cancer (Protocol)
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Handbook for Systematic Reviews of Interventions 5.0.0 (Higgins
2008). For the synthesis and meta-analysis of any quantitative
data, it is likely that heterogeneity will exist in the studies (that
is the psychological interventions and types of participants) so we
intend to use a random-effects model (which gives a conservative
confidence interval for the estimate of effect size). In the cases
where there are insufficient clinically homogeneous trials for any
specific intervention or insufficient study data that can be pooled,
a narrative synthesis will be presented.
Subgroup analysis and investigation of heterogeneity
Subgroup analyses will be conducted to test the interaction be-
tween the variables determined a priori and overall treatment ef-
fect. These will include the following.
• Age of participants (≤ 50 years versus > 50 years).
• Dose of psychological intervention (≤ 20 hours versus > 20
hours).
• Duration of psychological intervention (≤ 8 weeks versus >
8 weeks).
• Type of psychological intervention (individual versus
group).
• Type of therapy received (total mastectomy versus
conservative surgery, chemotherapy, radiotherapy and hormonal
therapy).
• Time point at which the outcome of the intervention was
assessed (≤ 4 months after surgery versus > 4 months) (Vos
2006).
Sensitivity analysis
The impact of the methodological quality on overall effect size
will be determined by sensitivity analyses. Sensitivity analyses will
be conducted to assess the robustness of our review results by
repeating the analysis with exclusion of studies of lower quality
and including only studies of higher quality.
ACKNOWLEDGEMENTS
We would like to thank Mr Fergus Tai for all his help throughout
the process of writing the protocol.
6
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∗
Indicates the major publication for the study

HISTORY
Protocol first published: Issue 10, 2010

CONTRIBUTIONS OF AUTHORS
Ghufran Jassimi (GJ) will be responsible for:

• organising the retrieval of papers;

• writing to authors of papers for additional information;
• screening search results; and
• entering any extracted data on RevMan.

All review authors (GJ, David Whitford (DW) and Ian Grey (IG)) will be responsible for:

• screening retrieved papers against inclusion criteria;

• appraising quality of papers;
• data collection for the review;
• extracting data from papers;
• screening data on unpublished studies;
• designing and writing the review; and
• analysis and interpretation of data.

Psychological interventions for women with non-metastatic breast cancer (Protocol) 9

Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
DECLARATIONS OF INTEREST
There are no financial conflicts of interest and the authors declare no association with any parties who may have vested interests in the
results of this review.

SOURCES OF SUPPORT

Internal sources
• New source of support, Not specified.
• Nil, Not specified.

External sources
• Nil, Not specified.

Psychological interventions for women with non-metastatic breast cancer (Protocol) 10

Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.