RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BENGALURU, KARNATAKA

SYNOPSIS PROFORMA FOR REGISTRATION OF SUBJECT FOR

DISSERTATION

1 Name Of The Candidate

And Address

Ms. RENCY ACHANKUNJU

S J B COLLEGE OF NURSING,BGS HEALTH AND EDUCATION

CITY,

KENGERI, BENGALURU 60.

2 NAME OF THE

INSTITUTION

S J B COLLEGE OF NURSING, BGS HEALTH AND EDUCATION

CITY,

KENGERI, BENGALURU 60.

3 COURSE OF STUDY &

SUBJECT

I YEAR M.Sc. NURSING ,

CHILD HEALTH NURSING.

4 DATE OF ADMISSION

25-06-2012.

5 TITLE OF THE TOPIC “A Study To Evaluate The

Effectiveness Of Self Instructional

Module on Knowledge Regarding

Bone Marrow Transplantation In

Children With Leukemia Among Staff

Nurses In Selected Hospitals,

Bengaluru”.

1

6. BRIEF RESUME OF THE INTENDED

WORK

6.1 Need for the study “Children are the world’s most valuable

resource and its best hope for the future”

John F. Kennedy

Cancer was recognized in ancient times, by skilled

observers who gave it the name “Cancer” derived from

Latin word Canceri meaning crab, because it stretched out

in many directions like the legs of the crab. The term

cancer is an “umbrella” word used to describe a group of

more than 270 disease in which cells multiply without

restraints, destroy healthy tissue endangering life. The

psychological and physiological impact of cancer on

patients and their families results in profound changes in

their life styles .Cancer is synonymous with the terms

“malignant neoplasm”, carcinoma. Cancer may result in

death in some and mutation for others.1

Childhood cancer is the second leading cause of

death in children under ages 5 to 14 years. Based on global

data it is estimated that 10–12 children less than 15 years

of age per 1, 00,000 populations per year develop cancer.

According to Population Based Cancer Registries (PBCR),

the age adjusted incidence of childhood cancer in India

varies from 3.2 per lakh to 14.1 per lakh. In India with

children forming 36% population, approximately 30,000 –

40,000 new cases of cancer constitutes 2.1 – 6.2% of all

cancers compared to 2 % in developed countries. The risk

2

of cancer appears to be slightly higher in male children

compared to female.2

Leukemia is a type of cancer that affects the blood

and bone marrow, the spongy center of bones where our

blood cells are formed. The disease develops when blood

cells produced in the bone marrow grow out of control. In

the United States, there were approximately 43,050 new

cases of leukemia, and 21,840 deaths in 2010. An

estimated 44,600 new cases of leukemia are expected to be

diagnosed in the United States in 2011. Worldwide, an

estimated 350,000 people are diagnosed with leukemia

each year, with approximately 257,000 deaths annually.3

The incidence of different types of leukemia varies

with the age in different parts of India. The data of cases

diagnosed as leukemia, during a span of 10 years (1975 to

1984) were analyzed to evaluate its incidence at National

Marrow Donor Program (NMDP) and to compare these

observations with those reported by other workers from

India and abroad. Out of total 242 cases, 64 cases

(26.45%) were children and 178 were adults (73.55%).

Among the children, 41 were males and 23 were females

(M:F ratio of 1.7: 1). In the adults, 136 were males and 42

females and thus the ratio was 3.2: l. The overall M: F

ratio was 2.7:1.4

When a child has leukemia, the bone marrow, for

an unknown reason, begins to make white blood cells that

do not mature correctly, but continue to reproduce

themselves. These abnormal cells reproduce very quickly

and do not function as healthy white blood cells to help

fight infection. When the immature white blood cells,

called blasts, begin to crowd out other healthy cells in the

3

bone marrow, the child experiences the symptoms of

leukemia i.e., infections, anemia, bleeding.4

Chemotherapy and radiotherapy are essential

component along with surgery and other modality of

treatment in cancer therapy. In the event a child's bone

marrow is too severely damaged or weakened by the

leukemia, the transplant may be accomplished. A bone

marrow transplant(BMT) introduces new marrow into the

child's system in order to produce healthy blood cells to

fight infections and to repair the body. Healthy bone

marrow produces red blood cells, white blood cells and

platelets. This is a new area that is receiving increasing

attention in the medical profession. The decision by a

parent for a BMT is one of the most emotional decisions

in a fight against leukemia.5

Today, over 3,000 people receive allogenic BMTs

(bone marrow from a third party). The number of

autologous BMTs (the patient's own bone marrow) for

children is increasing at this time. The National Marrow

Donor Program established at US and Canada estimates

that the number of allogenic transplants would triple if

available donors could be found6. A number of the side

effects are temporary, such as hair loss, mouth sores,

diarrhea, vomiting, and other side effects due to the

chemotherapy, radiation and BMT. Although the side

effects could not be minimized, they normally are

temporary and will pass as the child recovers.6

The National Marrow Donor Program ("NMDP")

was established in 1986 at US and Canada which has

approximately 1.2 million registered potential donors in

1997. The NMPD generally estimates 120 days from the

4

first request before bone marrow can be delivered. The

goals of NMPD are honorable in attempting to expand the

list of donors and thus improve the odds of finding

matches, and to shorten the 120 day search time7.

Nursing the child with cancer is

challenging .Nurses have a significant supportive role in

identifying and meeting the possible needs in the

management of children with cancer and helping them and

their parents to understand various therapies. They play a

vital role in the prevention and the management of

expected side effects of treatment, to assist the children to

maintain quality of life, maintaining optimum nutrition

status, remaining free from infection and achieving

appropriate growth and development. Thus helping the

child and family to live a normal life as possible and cope

with the emotional aspects.8

As a result of vital programs provided by the

leukemia research foundation, countless lives are saved.

Childhood cancers are rare, but are an important cause of

morbidity and mortality in children younger than 15 years.

Leukemia can occur at any age, although it is most

commonly seen in children between 2 and 6 years of age.

The disease occurs slightly more frequently in males than

in females.9

In the past few decades, bone marrow

transplants have become an established and successful

treatment for children with cancer and certain genetic

diseases. Transplants can be a scary prospect for families

considering the procedure, there are great risks, and it

takes a long time to recover. But transplants are often a

lifeline for children with no other treatment options.10

5

When normal levels of treatment for a child with

cancer aren’t enough, more extreme measures may be

necessary. Higher levels of radiation, used to kill

cancerous cells, can also threaten important bone marrow

and necessitate a bone marrow transplant, a complicated

but lifesaving procedure.11

The transplant itself is simple; the marrow is

infused into the blood like a blood transfusion. However,

before the transplant, the child has typically been treated

with up to two weeks of high doses of potentially lethal

chemotherapy or radiation therapy or both that cause side

effects for one to three months afterwards.12

During this time, the child experiences many

complications, is at high risk for developing a serious or

fatal infection, and must be hospitalized in an isolation

unit. Cells from the transplant begin to grow after about

one month, but full recovery takes one to two years.

Children undergoing the procedure cannot go to school,

church, malls, movies, or other group activities for

approximately one year.13

Today bone marrow transplantation is performed

only in children with very serious and life-threatening

conditions. The majority of children going through the

procedure have a life expectancy of less than one year

without treatment. About half of the children who have a

transplant are cured of their underlying disease. The others

die from relapses of their disease or complications from

the procedure. Younger children and infants with genetic

diseases and children who have only had one relapse of

their cancer have the best prognosis. In these cases 70 to

90 percent of children do well.14

6

Boulad F, Steinherz P (1999) conducted a

retrospective analysis of the treatment of childhood acute

lymphoblastic leukemia in second remission was

undertaken to compare the outcome and prognostic factors

of seventy five children treated with chemotherapy or

allogeneic bone marrow transplantation (BMT). The

disease-free survival rate was 62% and 26% at 5 years,

respectively for the BMT and the chemotherapy. There

was an overall advantage for the BMT therapeutic

approach as compared with chemotherapy for patients

with ALL in second remission.15

Mark Weinblatt , Joseph , Indira Sahdev (1990)

suggested that "bone marrow transplant in its current state

may be neither ethical nor imperative as a therapy for

dying children." Bone marrow transplantation has been

found effective for a variety of otherwise incurable

diseases As a pediatric resident "her eyes were opened"

and she commented at great length about the difficult

ordeal that children go through, including pain, isolation,

mucositis, and long-term side effects. Additional questions

were raised about parents' ability to understand enough

about transplantation to make a decision "that is truly in

the child's best interest."16

From the available literature reviewed, it is found

that Bone marrow transplantation is a key component in

the treatment of childhood malignancies. Children who

undergo bone marrow transplantation need special nursing

care that is dependent on growth and developmental

issues. It also leads to many side effects that create

discomfort and stress to the child and family members.

Nurses play an important role in the care and education of

families and children undergoing Bone marrow

transplantation. Hence investigator found it relevant to

7

conduct a study on the effectiveness of a self instructional

module on bone marrow transplantation in children with

leukemia among staff nurses.17

6.2 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 unknown18.

A literature review is a written summary of the

state of existing knowledge on a research problem. The

talk of reviewing research literature involves the

identification, selection, critical analysis and written

description of existing information on a topic10 (Polit and

Hungler, 2003).

In order to accomplish this goal in the present study,

an attempt has been made to review and discuss the related

literature.

The review of literature of the present study was

collected, organized and has been presented under

following headings.

8

1. Literature related to bone marrow transplantation

in children with Leukemia.

2. Literature related to knowledge of among staff

nurses regarding bone marrow transplantation in

children with Leukemia

3. Literature related to effectiveness of self

instructional module.

1. Literature related to bone marrow transplantation

in children with Leukemia.

A cohort study was conducted to identify

the advantage of allogeneic transplant from compatible

related donors versus chemotherapy in children with

very-high-risk acute lymphoblastic leukemia. This

study quantified the impact of time elapsed in first

remission in the same cohort. The samples were 357

pediatric patients with very-high-risk acute

lymphoblastic leukemia, 259 received chemotherapy,

55 transplantation from compatible related and 43

from unrelated donors. The 5-year disease-free

survival was 44.2% overall and 42.5% for

chemotherapy only patients. The chemotherapy

conditional 5-year disease-free survival increased to

44.4%, 47.6%, 51.7%, and 60.4% in patients who

maintained their first remission for at least 3, 6, 9, and

12 months respectively. The overall outcome was

superior to that obtained with chemotherapy-only at

any time-point. The study concluded that the relative

advantage of transplant from compatible related

donors in very-high-risk childhood acute

9

lymphoblastic leukemia was consistent for any time

elapsed in first remission.28

A retrospective study was conducted to know the

impact of remission status, graft source, and imatinib

use on transplant outcomes for 37 children with Acute

lymphocytic leukemia(ALL) who received an

allogeneic HCT .Thirty seven children with all who

received ALL HCT were selected as study samples.

The study was conducted at the University of

Minnesota between 1990 and 2006. Thirteen patients

received imatinib therapy pre- and/or post-HCT

(imatinib group) and 24 patients, received either no

imatinib (n = 23) or only post-HCT relapse (n = 1)

(non-imatinib group).the result was no difference in

disease-free survival (DFS) or relapse between the

imatinib and non-imatinib groups at 3 years (62%/15%

vs. 53%/26%; P = 0.99; 0.81, respectively). There was

no significant difference in transplant outcomes

between matched related donor or unrelated donor

recipients whereas patients receiving allogeneic HCT

in first remission (CR1) had superior DFS and less

relapse compared to patients transplanted in >or=CR2

(71%/16% vs. 29%/36%; P = 0.01; P = 0.05).Based on

this retrospective analysis at a single institution, the

use of imatinib either pre- and/or post-transplant does

not appear to significantly impact outcomes for

children with ALL and allogeneic HCT with the best

available donor should be encouraged. 29

A study was conducted to determine the

difference in outcome among 35 consecutive children

with ALL in third complete remission (CR3)

underwent stem cell transplantation (SCT) from

10

unrelated donors (UD). There was no significant

difference in outcome between mismatched unrelated

donor stem cell transplantation (MMUD-SCT) and

matched unrelated donor stem cell transplantation

(MUD-SCT). We conclude that MUD-SCT is an

effective treatment of ALL in CR3. Short duration of

CR1 and of CR2 and extramedullary site at first

relapse are particularly adverse. MMUD should also

be considered in high-risk patients, since the outcome

of MMUD appears similar to MUD.30

A study conducted to analyze the Role of

Hematopoietic Stem-Cell Transplantation in Infants

with Acute Lymphoblastic Leukemia in First

Remission and MLL Gene Rearrangements

results .Forty infants diagnosed Acute Lymphoblastic

Leukemia before age 12 months who received a

hematopoietic cell transplant (HCT) between July

1982 and February 2003 in first complete remission

(CR1; n = 17), CR2/3 (n = 7), or relapse (n = 16) were

selected. Patients were conditioned with

cyclophosphamide with total body irradiation (n = 39)

or busulfan (n = 1). Donors were matched related (n =

8), mismatched related (n = 16), or unrelated (n = 16).

Graft-versus-host disease (GVHD) prophylaxis was

methotrexate or cyclosporine (n = 7) or methotrexate

plus cyclosporine (n = 33). Thirty-nine patients

engrafted, 20 developed acute GVHD, and 7

developed chronic GVHD. Sixteen patients relapsed

and 7 died of other causes. Patients in CR1 had

disease-free survival (DFS) of 76% compared with

45% for CR2/CR3 and 8% for relapse (P < .001). Of

33 patients with cytogenetic data, 26 (79%) had MLL

gene rearrangement. Fourteen of these 26 were in CR1

11

and 11 survive in remission. Outcome was associated

with phase of disease, but having the MLL gene was

not a factor predictive of outcome. Late effects

included growth and other hormone deficiencies. The

study concluded that infants with ALL and MLL gene

have excellent DFS when they received transplants in

CR1, and consideration for transplantation in CR1 is

warranted.31

2. Literature related to knowledge of among staff

nurses regarding bone marrow transplantation in

children with Leukemia

A study was conducted to examine

nurses knowledge towards transplantology, a branch

of clinical medicine responsible for organ transplants.

84 registered nurses were interviewed. The

questionnaire was of an audit character and it was

filled under the supervision of interviewers. Results

show that nurses' knowledge about issues concerning

transplantology was very incomplete. Very few nurses

had their own experience in being a tissue donor

(blood, bone marrow) for another human being. Many

participants didn't see any difference between

diagnosed death of brain stem and being a potential

donor and they had inadequate knowledge about

transplantations.32

A descriptive study was conducted

to measure bone marrow transplant (BMT) nurses'

knowledge, beliefs, and attitudes regarding pain

management in 32-bed BMT unit in a 567-bed tertiary-

care institution located in the Midwestern United

States.39 BMT nurses (20 pediatric, 19 adult) having

12

7.05 years of experience was selected as samples for

this study . BMT nurses completed a 49-item;

investigator-developed questionnaire. The study

concluded that many BMT nurses had high knowledge

levels and positive beliefs and attitudes related to pain

management. The mean of correct responses to

knowledge items was 79%.The investigators identified

specific knowledge gaps. The variability of scores

indicated that some nurses are more expert than others

regarding pain management and therefore could be

resources for other nurses. Thus the study concluded

that educational offerings can increase knowledge and

promote positive beliefs and attitudes among BMT

nurses, thereby enhancing pain management.34

A study was conducted to evaluate the

contribution of nursing research and the utilization of

research findings in the field of bone marrow

transplantation (BMT) in Europe. The study identified

as issues needing further attention. One forty one staff

nurses were interviewed. An overall research strategy

for nurses has been suggested as well as academic

research support for those nurses who do not feel

confident carrying out research projects. The study

identified that the main nursing research priorities

included isolation techniques, psychosocial and quality

of life issues, staff issues, central line catheter care and

mouth care/management of oral mucositis. The same

study also showed that only 20% of the BMT units

regularly use research and research findings in their

day-to-day nursing practice.33

13

3. Literature related to effectiveness of self

instructional module.

A study was conducted on effectiveness of

self instructional module on Bio medical waste

management among staff nurses working in selected

hospital at Mangalore. The study revealed that self

instructional module increased the knowledge and

awareness among staff nurse regarding the

management of biomedical waste in which the post

test knowledge score was 83% with pre test score

being 46%34.

Singh Mathura conducted a study to assess

the effectiveness of SIM on biomedical waste

management in Teg Bahadur Hospital, Delhi. The

study revealed that there was significant increase in

their mean post-test knowledge score when compared

with their mean pre-test knowledge score with‘t’

value6.61 at 0.05 level of significance. Hence it was

concluded that SIM is effective in improving the

knowledge staff nurses.36

Machado AT conducted a study to evaluate

the effectiveness of self-instructional module on

oxygen therapy in Manipal. The study was conducted

in two phases. In Phase I learning needs were assessed

and in Phase II the SIM was developed and evaluated

on a sample of 30 nurses. The findings showed a

significant gain in post-test knowledge score compared

to the pre-test knowledge score with computed‘t’ value

22.2 at 0.05 level. Hence the researcher concluded that

SIM is useful material for self-learning.37

14

Problem statementA Study to Evaluate the Effectiveness of Self

Instructional Module on knowledge regarding Bone

Marrow Transplantation in Children with Leukemia

among Staff Nurses in Selected Hospitals, Bengaluru.

6.3. OBJECTIVES OF THE STUDY

1. To assess the knowledge regarding bone marrow

transplantation in children with Leukemia among

staff nurses.

2. To evaluate the effectiveness of self instructional

module on knowledge regarding bone marrow

transplantation in children with leukemia among

staff nurses.

3. To find out the association between pre test

knowledge scores regarding bone marrow

transplantation in children with leukemia among

staff nurses and selected demographic variables.

6.3.1. Hypotheses:

H1.  There will be statistically significant

difference between mean pretest and post test knowledge

scores on bone marrow transplantation in children with

leukemia among the staff nurses.

15

H2. There will be significant association between

the pre test knowledge score regarding bone marrow

transplantation among the staff nurses and selected

demographic variables

6.3.2. Variables

1. Independent variable: Self instructional module on

bone marrow transplantation in leukemic children.

2. Dependent variable: Knowledge of staff nurses

regarding bone marrow transplantation in leukemic

children

3. Demographic variable: Age, gender, educational

background, and working experience.

6.4. OPERATIONAL DEFINITIONS

1. Effectiveness: In this study it refers to desired

gain in knowledge scores as determined by significant

difference in pre-test and post-test scores on the structured

knowledge questionnaire.

2. Self Instructional Module: In this study it

refers to organized written information regarding bone

marrow transplantation in children with leukemia

developed by the investigator and validated by experts.

3. Bone marrow transplantation: A bone marrow

transplant is a procedure to replace damaged or destroyed

16

bone marrow of a child with leukemia with healthy

matching bone marrow from a donor.

4. Children: In this study, children refers to

individual between age 0-18 years who are diagnosed,

with leukemia and are treated with bone marrow

transplantation.

5. Leukemia: A progressive, malignant disease of

the blood-forming organs, marked by distorted

proliferation and development of leukocytes and their

precursors in the blood and bone marrow.

6. Staff nurse: In this study it refers to the

registered nurses working in pediatric units of selected

hospitals at Bengaluru.

6.5 Assumptions

1. The staff nurses will have some knowledge regarding

bone marrow transplantation in children with leukemia.

2. Self instructional module will improve the knowledge

of staff nurses regarding bone marrow transplantation in

children with leukemia.

6.6 DELIMITATIONS

1. The study is limited to staff nurses who are working in

pediatric units of selected hospitals.

2. The study is limited to knowledge regarding bone

marrow transplantation in children with leukemia only.

17

7. MATERIAL AND METHODS:

7.1 Source of Data : Staff nurses who are working

in pediatric units of

selected hospitals,

Bengaluru

7.2 Method of Collection OF Data

7.2.1 Research approach : Evaluative approach

7.2.2Research design : Pre experimental one

group pretest- post test design

7.2.3 Setting : Selected hospitals with

pediatric department Bengaluru.

7.2.4 Sample and sample size : 60 staff nurse

7.2.5 Criteria for data Collection

7.2.5.1 Inclusion Criteria: 1. Staff nurses who are working in pediatric unit.

2. Staff nurses who are willing to participate.

7.2.5.2 Exclusion Criteria:

1. Staff nurses who are not involved in direct patient

care.

7.2.6 Sampling technique : Non-

probability convenience sampling

18

technique

7.2.7 Tool of research : The research

instrument will include two parts

Part 1 – Demographic Performa

Part ll – Structured knowledge questionnaire

regarding bone marrow transplantation in leukemic

children.

7.2.8 Collection of data

1. The formal permission will be obtained from hospital

authority.

2. The informed consent will be taken from participants.

3. Investigator collects data from staff nurses through self

administered structured questionnaire followed by

distribution of self instructional module.

4. Post test will be done after seven days

7.2.9 Duration of data collection : Four

weeks

7.2.10 Method of data analysis and

presentation:

Data obtained from the sample will be organized and

analyzed with the use of both descriptive and inferential

statistics

19

a) Descriptive statistics1. Frequency and percentage distribution will be used

to describe the demographic variable of staff nurses.

2. Mean, median, mean percentage, range and standard

deviation will be used to describe the knowledge

regarding bone marrow transplantation in leukemic

children among staff nurses.

b) Inferential statistics1. Paired‘t’ test will be used to evaluate the

effectiveness of self instructional module on

knowledge of staff nurses regarding bone marrow

transplantation in leukemic children.

2. Chi square test will be used to find the association

between knowledge regarding bone marrow

transplantation in leukemic children among staff

nurses and selected demographic variables.

Analyzed data will be presented in the form of tables,

diagrams and graphs based on findings.

7.3 Does the study require intervention to be

conducted on patients or other human or

animals? If so please describe briefly.

Yes, the study will includes an intervention in the form of

self instructional module. However there will be no other

invasive or non invasive investigation on participant in the

study.

20

7.4 Has ethical clearance been obtained from

your institution?

Yes, consent will be obtained from concerned subjects and

authority of institution.

Privacy of subjects, confidentiality and anonymity of

the data will be guarded

Scientific objectivity of the study will be maintained

with honesty and impartiality.

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6.

9. Signature Of The

Candidate

10.Remarks Of The Guide

The study is feasible and of genuine interest of

the student.

27

11. Name And Designation Of

11.1. Guide Mr. Hanock Reuban

Prof/Principal

SJB College Of Nursing,

Kengeri, Bengaluru-60.

11.2. Signature

11.3. Co-Guide Mrs. Rachana Das

Lecturer

SJB College Of Nursing,

Kengeri, Bengaluru-60.

11.4. Signature

11.5. Head Of The

Department

Mr. Hanock Reuban

Prof/Principal

SJB College Of Nursing,

Kengeri, Bengaluru-60.

11.6. Signature

12 12.1. Remarks Of The

Principal

The topic for the study is relevant and

forwarded for needful action.

12.2. Signature

28