Download PROTOCOL FOR DISSERTATION SUBMITTED BY, JERIN SARAH

PROTOCOL
FOR
DISSERTATION
SUBMITTED BY,
JERIN SARAH NINAN,
M.SC., NURSING-1ST YEAR.
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA.
PERFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION.
1.NAME OF THE STUDENT &
Jerin Sarah Ninan
ADDRESS
M.Sc., Nursing – Ist Year
St. John's College Of Nursing
Bangalore- 560 034.
2.NAME OF THE INSTITUTION
St. John's College Of Nursing
3.COURSE OF STUDY & SUBJECT
Master's Degree In Nursing
Medical Surgical Nursing.
4.DATE OF ADMISSION
May 5, 2008
5.TITLE OF THE TOPIC
Knowledge of family member of patients receiving cancer chemotherapy regarding
the home management of its side effects at St. Johns Medical College Hospital, Bangalore
with a view to develop an information booklet.
6. BRIEF RESUME OF THE INTENDED WORK
6.1. Need for study:
Cancer, a term that elicits a shock in the nerve endings of every individual
touches every country in the world. Cancer is one of the commonest diseases affecting
around 10 million new cases per year worldwide. In India, cancer prevalence is estimated
to be around 2.5 million, with 8,00,000 new cases and 5,50,000 deaths per year1.
Cancer chemotherapy is the corner stone of cancer treatment in the domain
of medical oncology which can prolong the life of cancer patient .Chemotherapy is one of
the many weapons that injure the enemy of cancer cells and sometimes it is so potent that
the cancer completely
retreats2.More than half of all people diagnosed with cancer
receive chemotherapy which helps treat their cancer effectively, enabling them to enjoy
full productive lives3.
Chemotherapy is generally not painful, that is, it does not directly cause
pain, but the side effects of chemotherapy can initiate the pain experience. Most of the
chemotherapy drugs administered have some or the other side effects which can even
initiate the pain experience4.
The side effects from cancer chemotherapy depend on the type of drug,
dosage, frequency and its duration of administration. According to American Cancer
Society the most common side effects include: nausea, vomiting, hair loss, fatigue,
increased chance of bruising & bleeding, anemia and infection. However today most of
the side effects associated with chemotherapy can be prevented or minimized3.
Each individual experiences life through relationship with others.
Family members and close friends are often the people who provide assistance in the dayto-day lives of cancer patients and they are the major source of social support for cancer
patients. All our patients had been discharged to the care of their family5. Family
members can influence the patient’s response to all cancer treatment including
chemotherapy. Care by the family members become increasingly important during the
terminal phase of illness. Thus caring for an individual cannot occur in isolation from that
person’s family.
The American Cancer Society states that patient education should include
information on drugs given, dosage schedule, side effects and interventions to alleviate
the side effects. The National Institute of Clinical Excellence [NICE] guidance advises
that the cancer services for adults should make sure that patients and their families are
informed, cared for and supported.
Majority of cancer chemotherapy is given on an out-patient basis6.
Moreover, most of the side effects of chemotherapy are delayed predisposing the patients
to experience them at home after discharge. Hence it becomes important for the nurses to
equip the family members with certain amount of knowledge that would help them in the
early identification and prevention of those side effects.
Very few studies have been done related to the assessment of knowledge of
the family members of patients undergoing chemotherapy on the management of side
effects of chemotherapy.
The investigator, during her experience also found that the
family members are provided with only minimal amount of information regarding the
after-effects of chemotherapy, when and how to seek professional assistance. In the
investigator’s personal experience also the lack of proper information on the diagnosis
had a negative impact on the patient and family. Such reports motivated the investigator
to carry out this research work.
6.2. Review of literature
A thorough literature review focusing on prior researches related to the topic of
the study gives a strong foundation on which to base knowledge thus the survey of
literature is one of the vital parts of any research endeavor7.
The investigator has organized the related literature under the following
headings after reviewing various research studies and non research literature.
Studies relevant to side effects of chemotherapy
A study on the occurrence of alopecia in patients on combination chemotherapy at
Kasturba Medical College Hospital among 56 confirmed cases of malignancy showed
alopecia was seen in 42 patients , amongst whom 31 manifested alopecia after the first or
second cycle of chemotherapy8.
A study on perception of chemotherapy side effects among cancer verses non
cancer patients on 146 patients with cancer and 224 patients without cancer revealed the
following findings: For cancer patients, loss of hair{50%}, changes in taste{46%},
constantly being
tired{42%}, affects work duties{39%}, changes in smell
perception{35%} were most frequently perceived as bothering very much. Nausea and
vomiting were ranked 11th & 22 respectively. The 5 side effects perceived as most
troublesome in decreasing order: nausea, loss of hair, constantly vomiting and changes in
the way things taste. For non-cancer patients, those factors potentially bothersome
included financial hardship {82%}, hardship on family {78%}, vomiting {73%},
dyspnoea {70%} and inability to perform work {69%}9.
A study on ‘Recalled side effects and self care actions of patients receiving
inpatient chemotherapy’ among 59 adult patients on chemotherapy showed that more
than 50% reported having alopecia, fatigue, nausea, taste changes, appetite loss, sleeping
difficulties and constipation during the post hospitalization period10.
A study on expectations of cancer patients regarding treatment related side
effects in Bhopal among 160 newly diagnosed cancer patients planning to undergo either
chemotherapy or radiotherapy found out that nearly 77.5% expected hair loss, 59% sleep
disorders and 92% fatigue. It was also found that most of the cancer patient expected high
number of side effects related to cancer treatment11.
Studies relevant to knowledge regarding side effects of chemotherapy
A study on “out patient chemo: patients and family members concerns and
coping strategies” among 64 adult patients and 69 family members on chemotherapy
found that patients reported fewer concerns than their families, but both had similar
concerns and rated them as high in intensity6.
A study on “Cancer patients & home care: Extent to which required services
are not received” among 37 patients using secondary analysis design identified that
41% of patients who did not receive home care had complex problems, indicating that
health care professional need to continue efforts to identify & eliminate barriers to the
receipt of required ongoing home nursing services for patients with cancer & their
families12.
A study on measuring the informational intervention for chemotherapy
knowledge and self care behavior among 48 patients on chemotherapy indicated that
patients who received information on side effect management techniques performed more
self care behaviors than the patients who received combined information on drug and side
effect management13.
6.3. Statement of the problem
A study to assess the knowledge of family member of patients receiving
chemotherapy regarding home management of its side effects at St. John's Medical
College Hospital, Bangalore with a view to develop an information booklet.
6.4. Objectives of the study
1. To assess the knowledge of family member of patients receiving cancer
chemotherapy regarding its side effects.
2. To assess the knowledge of family member of patients receiving cancer
chemotherapy regarding home management of its side effects.
3. To find the association of knowledge of family member with selected
demographic variables such as age, gender, education, income, previous
experience, duration of patient’s illness, and number of chemotherapy cycle.
4. To develop an information booklet on home management of cancer chemotherapy
side effects.
6.5. Operational definition
1. Knowledge:
In this study 'knowledge' refers to the level of understanding of family member
of patients receiving cancer chemotherapy regarding home management of its
side effects as measured by the response scores to the items in the structured
knowledge questionnaire.
2. Family Member:
In this study 'family member' refers to the first degree relative [Parents /Spouse
/ older children] taking care of the patient and accompanying him/her at the time
of chemotherapy.
3. Cancer Chemotherapy:
In this study 'cancer chemotherapy' refers to the use of drugs to kill
cancer cells either in the form of injection or oral tablets.
[American Cancer Society]
4. Side effects:
In this study, 'side effects' refer to the common adverse effects caused
by chemotherapy treatment which include G.I symptoms like nausea, vomiting,
diarrhea, oral mucositis, general manifestations like hair loss, fatigue, pallor, dry
skin , and upper respiratory infection.
5. Home Management:
In this study, 'home management' refers to the ability of the family
member to recognize manifestation of cancer chemotherapy side effects and
measures taken to manage the side effects.
6. Demographic variable:
In this study, 'demographic variable' refers to age, gender, education, and
income, duration of illness, previous experience and number of chemotherapy
cycles.
7. Informational booklet:
In this study, ‘information booklet’ refers to a set of information related
to ways of managing the side-effects of cancer chemotherapy at home.
6.6. Assumption
The family member of the patients receiving cancer chemotherapy will have
some knowledge about home management of its side effects.
6.7. Delimitations
The study is limited to the family member of patients receiving only cancer
chemotherapy treatment at St. John's Medical College Hospital, Bangalore.
6.8. Projected outcome
The findings of this study will reveal the existing knowledge of the family
member regarding home management of chemotherapy side effects. This will help to
develop an information booklet on home management of chemotherapy side effects and
also enhance the health personnel to impart health education on ways of preventing and
managing the common side effects of chemotherapy. This protocol will help to improve
the quality of life of cancer patients on chemotherapy and also help them to accept the
treatment positively.
6.9. Hypothesis
There will be a significant association between the knowledge and selected
baseline variables [age, gender, education, income, previous experience, duration of
patient’s illness] at 0.05 level of significance.
7. Material & method:
7.1. Sources of data:
7.1.1. Research Design:
Descriptive design will be used for this study.
7.1.2. Setting:
The study will be conducted in the male and female medicine and surgery
wards, gynec ward, pain & palliative center and day care ward of St. John's Medical
College Hospital which is a tertiary care teaching institute. It is a 1200 bedded
multi specialty hospital receiving 5to10 patients daily for chemotherapy in medicine,
surgery and gynec wards, pain and palliative center, and day care ward.
7.1.3. Population:
Population in this study will comprise the first degree relative [parent/
spouse / son or daughter>18 years] of patients receiving cancer chemotherapy in the
wards & day care centre of St. John's Medical College Hospital, Bangalore.
7.2. Methods of data collection
7.2.1. Sampling procedure:
Purposive sampling technique will be used.
7.2.2. Sample size:
The sample size for this study will consist of 100 family members of
patients receiving cancer chemotherapy St. John's Medical College Hospital,
Bangalore.
7.2.3. Inclusion criteria for sampling:

Family member of patients receiving only chemotherapy.

First degree family member>18 years seeking health care
services in the OPD and wards of St. John's Medical College
Hospital.

Family member who can understand English, Kannada, Tamil
or Hindi

Family member who are willing to participate in the study.

Family member who are available during the study period.
7.2.4. Exclusion criteria

Family member of patients receiving other modalities of
treatment.

Family member<18 years and who are not first degree
relatives.

Family member of patient who is a health professional.

Family member of patients on chemotherapy and radiotherapy.

Family member of patients on first cycle of chemotherapy.
7.2.5. Instrument used:
Section 1: Demographic data.
Section 2: Structured questionnaire to assess knowledge regarding side
effects of chemotherapy.
Section 3: Structured questionnaire to assess knowledge regarding
management of chemotherapy side effects.
7.2.6. Data collection method:
After
obtaining
a
formal
permission
from
the
Hospital
administration, Institutional ethical committee, Medical superintendent, Nursing
superintendent and Head of the departments of medicine and surgery, pain & palliative
care, family member of the patient receiving chemotherapy will be selected from wards
and day care ward using purposive sampling technique. The purpose of the study will be
explained before collecting the demographic variable followed by assessment of their
knowledge using 'knowledge questionnaire'. Each questionnaire would take 15-20 min
for answering. Data will be collected from the family members during chemotherapy
session.
7.2.7. Data analysis plan:
Data analysis will be done by using descriptive methods such as
frequency, percentage, mean and standard deviation and inferential methods such as chisquare test. The findings will be presented in the form of tables and figures.
7.3. Does the study require any investigations or interventions to be conducted on
patients or other humans or animals?
No.
7.4. Has ethical clearance been obtained from your institution?
Administrative permission and ethical clearance with regard to the study will be
obtained from the research committee of St. John's Medical College Hospital, Bangalore
prior to conducting the study.
BIBLIOGRAPHY
1. National Cancer Registry Programme: Annual Report. ICMR. New Delhi. 87.
2. Bullock BA, Henze RL. Focus on Pathophysiology. Philadelphia: Lippincott
Publishers; 2000.69-70.
3. http.//www.tour2india4health.com/ accessed on 03-11-2008.
4. Lewis SL, Heitkemper MM, Dirksen SR, O’brien PG, Bucher l. Medical Surgical
Nursing –Assessment and Management of Clinical Problems. 7th ed. St. Louis:
Mosby Publishers; 2007. 271 -72, 285-301.
5. Potter PA, Perry GA. Fundamentals of Nursing. 5th ed. St.Louis: Mosby
publishers; 2001.17, 145.
6. Dodd JM, Dibble SL, Thomas ML. Outpatient chemo: patient’s and family
members’ concerns and coping strategies. Public Health Nursing 2007; 9(1): 3744.
7. Polit DF, Beck CT. Nursing Research- Generating & Assessing Evidence for
Nursing Practice. 8th ed. Philadelphia: Lippimcott Williams & Wilkins Publishers;
2008.343-344.
8. Ganesh SP, Dinesh M . Occurrence and Severity of Alopecia in Patients on
Chemotherapy. Indian Journal of Cancer 2000 June- Sept; Vol. 37 (2 & 3): 95103.
9. www.google.com; accessed on 20-10-2008.
10. Foltz AT, Gainer G, Gullate M. Recalled side effects and self care actions of
patients receiving inpatient chemotherapy. Oncology Nursing Forum 1996 May;
23 (4) : 678-83.
11. Tiwari SL. Expectations of cancer patients regarding treatment related side effects
.Indian Journal of Community Medicine 2007; 32(1).
12. Yost IS. Cancer patients and home care: Extent to which required services are not
received. Cancer Nursing 1997 April; 20 (2): 105-14.
13 Dodd MJ. Measuring the informational intervention for chemotherapy knowledge
and self care behavior. Research Nurse Health 1984 Mar; 7 (1): 43-50.
8
SIGNATURE OF CANDIDATE
9
REMARKS OF THE GUIDE
10 NAME AND DESCRIPTION OF [IN
BLOCK LETTERS]
10.1 GUIDE
10.2 SIGNATURE
10.3 CO-GUIDE [IF ANY]
10.4 SIGNATURE
11 11.1 HEAD OF THE
DEPARTMENT
11.2 SIGNATURE
12 12.1 REMARKS OF THE
CHAIRMAN PRINCIPAL
12.2 SIGNATURE