RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. Name of the candidate and address Anil Kumar.S.Jaee M.Sc. Nursing 1st year, Noor college of Nursing, Bhoopasandra, Bangalore -94. 2. Name of the Institution Noor college of Nursing, Bhoopasandra, Bangalore 3. Course of study and subject M.Sc. Nursing 1st year, Medical-Surgical Nursing 4. Date of admission to the Course 01-06-2010

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Title of the Topic

A study to assess the effectiveness of self instructional module on knowledge of adverse effects of chemotherapeutic drugs and its home care remedies among patients following chemotherapy in Selected Hospital at Bangalore

6.BRIEF RESUME OF THE INTENDED WORK

6.1 INTRODUCTION
Cancer is a term used for diseases in which the abnormal cells divide without Control and are able to invade other tissues, To Many cancer implies a sentence; it implies suffering and pain Even today, despite considerable advances in treatment, cancer remains a fatal disease for number of patients. It is however, only rarely acutely fatal such that cancer can be regarded as a chronic disease Thus, the traditional aims of treatment prolongation of life and relief of suffering have largely been achieved although it must be recognized that such treatment may intrude into every area of the patients life1. The term cancer, neoplasm and tumor are more often used interchangeably by both the professionals and the lay public strictly speaking, these words are not interchangeable. The term cancer is used to refer to malignant neoplasms. Cancer is a disease of cells in which the normal mechanisms of the control of growth and proliferation have been altered. It is invasive, spreading directly to surrounding tissues as well as to new sites of the body1. Chemotherapy is a kind of treatment that uses drugs to attack cancer cell. It is called a systemic treatment since the drug, entering through the blood stream, travels throughout the body and kills cancer cells at their sites. These drugs may rarely be intended to have a local effect, but in most cases, the intention is to destroy cancer cells wherever they may exist in the body2. Chemotherapeutic drugs are chemically designed to target cells that are dividing and growing rapidly. Once they reach the cancer cells, they act to retard their growth eventually resulting in their destruction2. Since chemotherapy also affects normal actively diving cells as those in the bone marrow, the gastrointestinal tract, the reproductive system and in the hair follicles, most
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patients may experience some degree of side effects, which may include the following; pain, nausea and vomiting, fatigue, hair loss, anxiety, susceptibility to infections, decrease in blood cell count, mouth sores and ulcers, other side effects may include fluid retention, rashes, irritated bladder, swelling and numbness and aching of the joints, hands and feet etc., And may be associated with significant cognitive impairment3. As a result the cancer patient faces many adjustments not only to the disease itself but also to its treatment both of which may have significance and distressing physical effects. The National Centre for Complementary and Alternative Therapies, of USA defines that it combines conventional medical treatment and alternative and complementary treatment for which there is some high-quality scientific evidence of their safety and effectiveness. When the Person becomes aware that the he/she has serious illness such as cancer it has serious illness such as cancer it has stimulus characteristics of stresses sinister to disaster such as news of the sudden death of the loved one/passing death of sentence. The response of the individual depends upon his/her applause of the degree of threat the cancer possess and the personal life situation. The nursery attached to the cancer by the society as five Ds are death, disfigurement, dependence, and disruption of the family relationships4. Cancer can have a serious impact one patient well-being and quality of life the international literature reports a higher existence of psychosocial problems among oncologic clients primarily problems associated with difficulties in the family, duties in the household, wok and leisure, sexuality and finances and emotional distress. A considerable proportion of oncology patients experience significant levels of distress. This distressed patients also have unmet needs of psychosocial support5. Despite there being some experience in the private sector there are few reports on home chemotherapy programmers. A recent Australian study one reported the results of a randomized crossover trial where patients preferred to have their chemotherapy at home. Of the 20 patients in the trial patients preferred home treatment for reasons of convenience, avoidance of traffic and parking, a reduction in treatment associated anxiety, not burdening careers and being able to care for their dependants5.
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A home chemotherapy company was contacted and the necessary arrangements made. The home care company provided nursing care, administration of chemotherapy and blood sampling. The hospital pharmacy continued to provide the drugs to the chemotherapy suite where they were collected by the home care service each week and taken to the patients home for administration6.

6.2 NEED FOR STUDY

The 10 million new cancer cases seen each year worldwide, 4.7 million are in the more developed countries and nearly 5.5. million are in the less developed of the developed world, more than half of all cancers occur in the developing countries. In developed countries, cancer id the 2nd most common cause of death and epidemiological evidence points to the emergence of a similar trend in developing countries7. Cancer prevalence in India is estimated to be around 2.5 million, with over 8,00,000 new cases and 5,50,000 breaths occurring each year to this disease in the country. The goal of the cancer treatment is cure, control or palliation. Factors that determine the treatment modality are the cell type of the cancer, the location and size of the tumor, and the extent of the disease, the physiological and psychological status and the expressed needs of the patient also have an important part in determining the treatment plan, Theses factory influence the modalities chosen for treatment and the length of time the treatment is administered8. The goal of cure, control and palliation are achieved through the use of four treatment modalities for cancer; Surgery, Radiation therapy, Chemotherapy, Biologic therapy,5 and every treatment has got its own merits and demerits for the cancer patient who are at the receiving end9. Being nurse one should be able to understand the condition of cancer patients who are undergoing the chemotherapy. As this treatment has an effect on both the physiological and psychological aspects of human life viz. pain, sleep disturbances, nausea, vomiting, stress, anxiety, gastrointestinal disturbances etc10.

A descriptive study was conducted at UK to describe the side effects experienced by patients receiving CMF chemotherapy with breast cancer, for 52 women receiving chemotherapy. The instrument used for data collection was self-report questionnaire. The results reported a total 94 different side effects and among them the commonly reported side effect were alopecia (mean incidence=91%), fatigue (mean incidence=89%) and weight gain (68%) and Nausea ranked 12th in terms of incidence, but to open questions patients judged nausea and fatigue as the most troublesome problem experienced followed by difficulty in sleeping and sore eyes10. In the population of India it is estimated number of new 1.5 million cases of cancer diagnosed per year. The population of U.S is 295 million and yet. 1.5 million Cancer will be diagnosed. The estimated new cases of cancer in India per year are nearly 7 lacks and the start of the next millennium estimated 806.000. In Karnataka state in the southern part of India, it is estimated that annually there are 35,000 incident cancers, where at the prevalent cancer accounts to about 1,50,000. More than one third of these cancer cases are seen and attended to kidwai memorial institute of oncology10. The researcher has personally witnessed the diagnosis of cancer in many cases provokes a crisis resulting in an increase of regression and defense mechanism. The most of the oncologic clients undergone the psychological problems and social problems. The psychological problems are depression, anxiety, thought of death, insomnia, hopelessness. The social problems are social isolation financial crisis, dependency on family members. This motivated the researcher to assess the selected psychosocial problems among oncologic clients11.

6.3 REVIEW OF LITERATURE

Review of literature is a research process. It is essential for the researcher to analyze the existing knowledge before going into a new research study. The review of literature is considered essential to all types of the research process. Review of literature is a process of familiarizing oneself with the knowledge collected and assimilated, which will generate a picture of what is known and what is unknown12.

Cancer and its prevalence, the face of health care including scientific knowledge and care delivery systems, is ever changing, likewise the experience of cancer is changing for the clients and familys. Today a person confronted with a new diagnosis often knows someone who has survived cancer; yet cancer remains a frightening unknown for many. Some clients, especially older ones, still associate the word cancer with death13.

A survey was conducted in Netherland, to evaluate the impact of 5HT3 antagonist on patients perception of the side effects of chemotherapy. The data was collected for a sample of 197 patient using survey method on physical and non physical side effects of chemotherapy the results revealed that 80% of nausea and 57% vomiting was experienced by the patients and hair loss was found to be more distressing among women (p<0.01). The study reported that patients perceived nausea and vomiting to be the first and third most distressing side effects of chemotherapy14.

For the present study an extensive review of research and non-research literature relevant to the study was undertaken to develop deeper insight into the problem and to build the foundation of the study and is presented under following sub-headings15.

A cross sectional descriptive co relational study was conducted in Taiwan, to understand the co relation of symptom distress and coping strategies of patients with lung cancer. A survey was performed for a sample of 73 lung cancer patients in with 42 receiving chemotherapy and 31 receiving radiation therapy. The instrument used for data collection was physical distress scale, profile of the mood state and coping strategies scale and the results revealed that patients experienced 7.32, slight to moderate psychological symptom distress. Coping strategies high usage of problem focused coping strategy was evident among inpatients receiving chemotherapy. Women in age group of 41-50 used emotional focused approach strategy and adaptive behavior. There was significant correlation between physical symptom distress and coping strategies especially for fatigue, lack of appetite, insomnia and difficulty in breathing at 0.05 level. It also found, distress of tension-anxiety and age explained 39.4% of variance in physical symptom. Coping strategies frequency was 48.8% of variance in psychological distress symptom16.

A cross sectional descriptive study examined anxiety and depression and their effect on the quality of life of 218 patients with breast cancer undergoing chemotherapy of radiotherapy. The data was collected through self report survey derived from the hospital anxiety and depression scale; functional assessment of cancer therapy for breast cancer and from demographic and clinical characteristics the results showed that participants from chemotherapy group had higher percentage of anxiety17.

A prospective observational study in Singapore conducted among 108 breast cancer patients, to assess the incidence of nausea and vomiting in patients who receives adjuvant doxyrubicin and cyclophosmide bolus chemotherapy delayed anti emetics and CINV revealed that 14.3% of patients had the incidence of severe nausea on 3 rd day of chemotherapy. Anxiety and history of chemotherapy induced nausea were found to be associated with both acute and delayed nausea and history of motion sickness has association with delayed vomiting18.
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Patient reported side effects among 3 chemotherapy regimens for breast cancer viz. cyclophosphamode and fluorouracil combined with methotrexate (CMF), doxorubicin(CAF) or miloxantrone (CNF) were compared among 86 women with breast cancer. The instrument used for data collection was self care diary (SCD) recorded by patients. The outcome of the study reported, a mean of 3.2 -4.9 side effects at each point time. The most frequently reported side effects were fatigue, nausea, anorexia, taste changes and head ache. Severe nausea was reported more with women receiving CAF than receiving CMF or CNF (p>0.05) and moderate disruption in ADL was reported with those with CAF19.

A prospective observational study was conducted to determine chemotherapy induced nausea and vomiting in breast cancer patients at cancer center at northeastern Ontario. The data were collected through a daily dairy to record the nausea and vomiting for first 5 days of chemotherapy for 143 patients and results of the study reported that for 24hrs the prevalence of nausea and vomiting was 37% and 13% and 70% 15% during 2-5 days and severe emesis was reported by very few 10%20.

The fatigue levels and Coping strategies in 101Taiwanese lung cancer patients receiving chemotherapy were explored. The data were collected on demographic and disease related characteristics were collected from medical records: data on fatigue and coping were gathered from questionnaire. The results revealed that the Fatigue levels were significantly higher in patients receiving a third course of chemotherapy than in those receiving a first course (F = 3.7, p = 0.03). The most commonly used management category was energy conservation (n = 659), and the most commonly used strategy was sitting (n = 101) and lying down (n = 98). However participants rated exercise (mean = 3.9), sleep (mean = 3.8) and walking (mean = 3.6) as the most effective strategies21.

A study was conducted to assess the characteristics and correlates fatigue after adjuvant chemotherapy for breast cancer among women who has completed chemotherapy and compare group of 61 women no history of cancer. Standardized selfreport measures of fatigue sleep quality, menopausal symptoms, and coping as well as structured clinical interview to identify current and past psychiatric disorder were completed by all the participants. The results revealed that women with adjuvant chemotherapy reported more severe fatigue (P < .01) and worse quality of life because of fatigue )P <.05). Severe fatigue among patients was significantly )P < .05) related to poorer sleep quality, more menopausal symptoms, greater use of catastrophizing as a coping strategy, and current presence of a psychiatric disorder22.

The prevalence, severity and distress from physical symptoms and the prevalence of anxiety and depression in 192 patients with either breast or GI cancer or lymphoma about to undergo chemotherapy were assessed through hospital anxiety and depression scale and chemotherapy symptom assessment scale . The results of study revealed that among 192 subjects the prevalence of anxiety was 45%, depression was 25%physical symptoms like pain (48%), feeling of unusual tiredness (45%) and difficulty in sleeping (45%) were the most prevalent physical symptoms rated as most sever were pain (28%) difficulty in sleeping (26%) and feeling unusually tired (19%). Symptoms causing the most distress were pain (39%), constipation (18%) and nausea (16%). The gastro intestinal cancer with regression analysis indicated that symptom distress for malaise22.

A survey was conducted on the impact of cancer related fatigue on the lives of Cancer patients. The data were collected using a 25 min telephone interview technique for 379 cancer patient having prior history of chemotherapy. The results revealed that the 76% patients had fatigue with normal life and 88% indicated that fatigue caused an alteration in their daily routine22.

6.4 STATEMENT OF THE PROBLEM

A study to assess the effectiveness of self instructional module on knowledge of adverse affects of chemotherapeutic drugs and its home care remedies among patients following chemotherapy in Selected Hospital at Bangalore

6.5 OBJECTIVE OF THE STUDY

1. To assess the level of knowledge on adverse effects of affects of chemotherapeutic drugs and its home care remedies among patients following chemotherapy 2. To determine effectiveness of self instructional module on knowledge of adverse affects of chemotherapeutic drugs and its home care remedies among patients following chemotherapy 3. To find out the association between level of knowledge and selected demographic variables among patients following chemotherapy

6.6 OPERATIONAL DEFINITION

Assess
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It refers to gathering the information on knowledge of adverse effects chemotherapeutic patients.

Effectiveness
It refresh out form of self instructional module in improving the knowledge of adverse effects chemotherapy

SELF INSTRUCTIONAL MODULE

It refers an informational booklet which include the information on the knowledge of adverse effects chemotherapeutic dugs and its home care remedies.

PATIENTS
The person who are Diagnosed to have cancer and following chemotherapy.

CANCER
It is defined as the various diseases characterized by malignant tumors or other tissue by malignant tumors or other tissue degeneration that can spread locally or through the lymph or blood systems.

CHEMOTHERAPY
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It is defined the Science or practice of destroying disease causing microorganisms or malignant tissue by the use of chemicals, especially, Toxic ones.

ADVERSE EFFECTS OF CHEMOTHERAPY

The adverse affects are as follows. Gastrointestinal toxicity, myclosuppression like neutropenia and thrombocytopenia and other effects are alimentary lymphoma, cuteneous lymphoma, tumor lyses syndrome and CNS are renal lymphoma

6.7 HYPOTHESIS:
There will be significant not. difference in the knowledge of adverse effects of

chemotherapeutic among patients who receives self instructional module than who do

6.8 ASSUMPTION: Oncological patients may have inadequate knowledge regarding adverse effects in following chemotherapy. Knowledge enhances the practice of quality of living.

6.9 DELIMITATION: The study is limited to patients following chemotherapy. The period of study is limited to 6 weeks.

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7.0 RESEARCH METHODOLOGY

7.1 Source of Data

Patient admitted with cancer following adverse effects of chemotherapy at selected hospital Bangalore.

Research approach
Evaluate research approach

Research design
The research design for this study is quasi experimental design.

Setting for study

The study will be conducted in selected hospital at Bangalore.

Description of study Independent variable:-

In this study self instructional module is the independent Variable.

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Dependent variable:-

Knowledge of cancer patients undergoing chemotherapy adverse effects are the dependent variable in the study.

Population:The population included in the study in patients will oncological undergoing chemotherapy, both the males and females admitted in selected hospital at Bangalore during the period of study.

Sample:
In this study the sample consists of patients oncologic following chemotherapy.

Sampling technique:
Convenience sampling technique

Sample size:
The Sample Size in the study will be 40 patients with cancer. In that 20 will be control group and 20 will be experimental group.

Inclusion criteria
1. Patient between the age group of 20-70 years. 2. Both male & Female 3. Patients who are willing to participate in the study 4. Who can understand and read, and speak kannada or English
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Exclusion criteria
1. Patients who are not co-operative 2. Patients with serious complications

7.2 DESCRIPTION OF THE TOOL

It consist of two parts i.e. Part A and Part B Part A :- It consists of demographic variables such as age, sex, education, religion, income, duration of illness, etc. Part B:- It Consists of well structured questionairre on knowledge of adverse effects of chemotherapeutic drugs and its home care remedies.

7.3 Method of data collection

The formal concern will be obtained from the hospital authority and patients. The purpose of the study will be explained to the study participants. Data collection tool will be utilized to collect data from the study participants. Followed pre test self instructional module will be distributed to the study samples. After seven days post test will be conducted.

7.4 PLAN FOR DATA ANALYSIS

The data obtained from samples will be analysed in term of objectives of study, by using descriptive and inferential statatics.

7.5

DOES

THE

STUDY

REQUIRE

ANY

INVESTIGATION

OR

INTERVENTION ON PATIENTS OR OTHER HUMANS OR ANIMALS. IF SO PLEASE DESCRIBE BRIEFLY.

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NO
Self instructional module will be administered and knowledge level will be conducted on subject.

7.6 ETHICAL CONSIDERATION TOWARDS SAMPLE RELATED To Study

Permission will be obtained from the concerned authority in the hospital to conduct study. A written consent will be obtained from the participants for their willingness to participate in the study.

8. REFERENCES
1. Black Joyce.M,Jacob Esther Matassari. Medical Surgical Nursing : Clinical management and positive outcomes ;7th ed.Elesiver publications, pg no : 2171,217,335389 & 390 .2004. 2. Jaypee Brothers, Medical Surgical Nursing, B.T. Bhasavanthappa, medical Publishers, New Dehli 1st ed. Pg no 111,160 & 123, 2003. 3. Joyce.M. Black, Jane, Hokanson hawks Medical Surgical Nursing 7th ed, pg no 351 395 365 & 375, 2005 4. Linda.S. Williams.paula.D.Hopper. Medical Surgical Nursing 2nd ed pg no 123, 133, 135 & 137, 1999. 5. Vincent. T. Devita, Journal. Samuel hellman steven A. Rosenberg, principles and practice of oncology. 7th ed. Lippincat pg no 2139, 2799, 49 & 50, 2005 6. Mehlesen MY, Jensun AB, Zachariae B. Psychocial problems and needs among cancerclients. Ugeskr Laeger2007 Apr; 169(18): 1682-7. 7. Charistine, Miaskowski, Patriciabuchsel. Oncology nursing assessment ad clinical care. I ed. Mosby publication; 1999; 305-306.
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8. Stewart BS ,Kleihues P,eds.Cancer of female reproductive tract; In world Cancer Report.World Helth Organiza .Interanational agency for research in cancer ,Lyon ,France : IARC 2003 9. Dinshaw KA,Rao DN,Ganesh B.Tata Memorial hospital cancer Regestry Annual Report,Mumbai,India:1999. 10. Lewis Sharon ,Heitemper ,Dirksen .Medical Surgical Nursing: Assessment and management of clinical problems.6th ed. Washigton: Mosby ; 2004. Pg 301 & 306,307,316. 11. Holmes.S and Edurn.E. Patients and nurses perception of symptom distress in cancer. Journal of Advanced of Advanced Nursing .1989;14:840-846. 12. Babu N, Bhatnagar S. Fighting cancer is half the battle living life is the other half Cancer Res Ther.2005 Apr-Jun; 1(2): 98-102 13. Babu N, Bhatnagar S. Fighting cancer is half the battle living life is the other half Cancer Res Ther.2005 Apr-Jun; 1(2): 98-102 14. Mehnet A, Lehmannc. Assessment of psychosocial distress and resources in oncology. Psychother psychosom med psycho 2006 Dec; 56(12): 462-79. 15. Sibiliab J breen, Carl M Baraveli, Penelope Schofied, Michael Jefford, Patsy M Yates Et.Al. Is symptom bureden a predictor of anxiety and depression in patients with cancer about to commence chemotherapy. Medical Journal of Australia.2009; 190 (7): S99-S104. 16. Black Joyce. M. Jacob Esther Matassari. Medical Surgical Nursing : Clinical management and positive outcomes ;7th ed. Elesiver publications .2004.pg no :333 & 378. 17. Black Joyce.M,Jacob Esther Matassari. Medical Surgical Nursing : Clinical management and positive outcomes ;7th ed.Elesiver publications .2004.pg no :333 & 378.
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18.

Ting-Ting Kuo, Fung-Chima.Symptom distenss and coping stratergies in patients with non-small cell lung cancer. Cancer Nursing,2002; 25(4):309-317

19. De Boer-Dennet M,De Wit R,Schmitz P,Djotono J,ones Is .A comparison of patient perceptions of side effects of chemotherapy:the influence of 5HT3 antagonist. British Journal of Cancer.1997;76(8):1055-61. 20. Sitzia J, Huggins 1.Side effects of cyclophosphamide,methotrexate and 5 flurorouracil (CMF) chemotherapy for breast cancer. Cancer Practitioner .1998 JanFeb ; 6(1) :13-21. 21. Greene .D, Nail im, Fieler VK, Dudgeon Jones is .A comparison of patients reported side effects among three chemotherapy regimens for breast cancer. Cancer Practice.1994:Jan-Feb,2(1);57-62. 22. Vivianne Shis, Hee Siew Wanm, Alexander Chan. Clinical predictors of chemotherapy induced nausea and vomiting in breast cancer patients receiving abjuvant Doxorubicin and cyclophosphamide. http/www.theannals.com.

ELECTRONIC SOURCE
www.pumed.gov www.google.com www.yahoo.com www.medline.com

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Signature of the candidate Remarks of the Guide Name and Designation

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11.1 Guide 11.2 Signature 11.3 Co-guide 11.4 Signature 11.5 Head of the Department 11.6 Signature 12.1 Remarks of the Chairman / Principal

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