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CTRI Number  CTRI/2018/03/012387 [Registered on: 07/03/2018] Trial Registered Prospectively
Last Modified On: 06/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   quasi-experiment 
Study Design  Other 
Public Title of Study   A Study to assess the effect of Teaching Programme on patients knowledge on chemotherapy medicines, their side effect and management of side effects at Cancer specialty hospital. 
Scientific Title of Study   A Study to assess the effect of Structured Teaching Programme on knowledge of patients with Acute Myeloid Leukemia on Chemotherapy schedule, Side effects and its Management at a Tertiary cancer center 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Project_No_2012 Version no 1.0 December 2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Rashmi Anand Methry 
Designation  Staff Nurse C 
Affiliation  Tata Memorial Center 
Address  Nursing Department,Tata Memorial Hospital, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820757466  
Fax    
Email  Rush_rush84@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mrs Prathepa Jagdish 
Designation  Staff Nurse C 
Affiliation  Tata memorial Center 
Address  Nursing Department,Tata Memorial Hospital, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224146560  
Fax    
Email  prathepa_jagadish@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Ms Rashmi Anand Methry 
Designation  Staff Nurse C 
Affiliation   
Address  NURSING DEPARTMENT, Tata Memorial Hospital, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820757466  
Fax    
Email  Rush_rush84@rediffmail.com  
 
Source of Monetary or Material Support  
TATA MEMORIAL HOSPITAL Dr. E Borges Road, Parel, Mumbai - 400 012 India  
 
Primary Sponsor  
Name  Tata Memorial Hospital  
Address  Dr Borges Road Parel Mumbai 12 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Not Any  Not Any 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
MsRashmi Anand Methry  Tata Memorial Hospital  OPD No 20 Adult Heamato-Lymphoid OPD, Main Building Department of Medical Oncology Tata Memorial Hospital Parel Mumbai Tel No 022241770
Mumbai
MAHARASHTRA 
9820757466

Rush_rush84@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients with Acute Myeloid Leukemia on Chemotherapy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Age above 18 years & diagnosed with AML
2.Patients planned 3+7 protocol chemotherapy
3.Patients receiving 3+7 protocol chemotherapy
4.Patients able to read, write understands Hindi/ English Marathi.
5.Registered with TMH.
 
 
ExclusionCriteria 
Details  1.Relapsed AML
2.Paediatric patients
3.Patients those are not willing to participate.
4.Patient on maintenance
5.Palliative patients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Knowledge of patients on chemotherapy schedule, side effects and its management.  7 days after structured teaching programme 
 
Secondary Outcome  
Outcome  TimePoints 
Not any  Not any 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/03/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not any 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
INTRODUCTION AND BACKGROUND
"Education is the most powerful weapon which you can use to change the world." Nelson
Mandela
“When you know better you do better.” ― Maya Angelou
Acute myeloid leukemia (AML) is a hematopoietic stem cell disorder characterized by the
proliferation and accumulation of immature hematopoietic cells in the bone marrow and blood.
This malignant alteration in hematopoietic stem cells leads to a loss of normal hematopoietic
function, which, if left untreated, typically leads to death within weeks to months of its clinical
presentation.
AML accounts for approximately 20% of acute leukemia in children and 80% of acute leukemia
in adults. The incidence of AML progressively increases with age and in adults over the age of
65 years, the incidence is approximately 30 times the incidence of AML in children.AML is
slightly more common among men than among women, but the average lifetime risk in both
sexes is less than ½ of 1%.The overall five-year relative survival rate for leukemia has more than
quadrupled since 1960As per the cancer statistics in US in the year 2017, the estimated new
cases of AML are 21380 and the percentage of all new cases in 2017 is 1.3%. The estimated
deaths in year 2017 are 10590, The percentage of surviving 5 years is 26.9 %
Incidence in India- While the average rate of incidence in India is lower than that in the United
States of America, population-based cancer registry shows an alarming rise in cases of blood
cancer in Mumbai and Delhi. The figures in the rural areas, however, are still much lower For
men, the deadliness of leukemia in India peaks at age 80+. At 13.9 deaths per 100,000 men in
2013, the peak mortality rate for men was higher than that of women, which were 10.1 per
100,000 women. The annual mortality rate per 100,000 people from leukemia in India
has decreased by 4.6% since 1990, an average of 0.2% a year.
In TMH yearly thousands of patients register but only 90 to 120 patients yearly gets admitted for
treatment because of bed constraints
The primary treatment modality for these hematological diseases requires a systemic treatment
approach using chemotherapy, immunotherapy, and more recently targeted therapies
Treatment of AML begins with induction chemotherapy, with the goal of achieving Complete
Remission with a resolution of morphologically detectable disease and the restoration of normal
blood counts. Both chemotherapy and HSCT have been utilized and each approach has a major
role in the treatment of this disease.
The goals of therapy- Normalization of hematopoiesis resolution of cytopenias or
leukocytosis/lymphocytosis, Effective treatment of potential sanctuary sites or extramedullary
disease, Elimination of minimal residual disease, Suppression of emerging resistant clones.
Minimizing treatment related toxicities and Maintaining or improving quality of life is critical to
effective treatment, Supportive care is an integral component of an effective Individualized
cancer treatment plan that minimizes potential toxicities, maximizes therapeutic outcomes, and
maintains optimal quality of life for the patient.
NEED FOR THE STUDY
In today’s era the knowledge is important. To empower the patients with the knowledge which is
required during the management of disease over the long duration can help in better outcome
Due to a weakened immune system and a highly decreased capacity of the body to fight
infection, patient with acute myelocytic leukemia are vulnerable and in danger of developing a
number of complications. These complications can be immediate and short-term or long-term or
delayed
It is important that patients treated with chemotherapy be educated about what to expect from
their regimen and the correct use of supportive care medications at home. In addition to patient
education, it is equally important to determine any barriers that may hinder their understanding
of the education they are provided
It is important that patients are educated about their chemotherapy and management of adverse
effects prior to and during subsequent cycles of treatment to abate the anxiety and distress that
may be associated with a lack of knowledge
Patient education should include teaching about the potential for and consequences of
neutropenia, Preventive measures to decrease the risk of infection, Reportable signs and
symptoms of infection and what to do when signs and symptoms occur
Patients coming for treatment of AML at Tata Hospital come from various socio cultural, and
educational background which differentiates their level of understanding and knowledge. Due to
the increase in the number of patients coming from various parts of India and despite giving
instructions due to different level of understanding there can be a gap between the patient’s
knowledge and understanding.
Various research studies show that the planned education provided by the health-care providers
had a positive effect on the symptom control of patients receiving chemotherapy
Hence this study assesses the effectiveness of a structured teaching programme on the awareness
of patients on chemo schedule and its management in acute myeloid leukemia
he teaching programme would provide information about the disease, treatment and care
related to acute myeloid leukemia
REVIEW OF LITERATURE
Mukaddar Molloglu & Gulyeter Erdogan, Turkey had conducted a performance of a planned
education model in patients receiving chemotherapy can alleviate the side effects of
chemotherapy and thus can increase the quality of the patients’ lives.(5)
T. Elumelu et al had conducted a study at university college hospital Ibadan Nigeria where a
questionnaire was used to assess the knowledge and experience of patients with cancers and it
showed that (98%) had prior information about chemotherapy and possible side effects. 95% of
these patients expressed satisfaction with the chemotherapy treatment received and coped with
the side effects because they were well prepared.(6)
A study was conducted to know the effectiveness of a Nursing Intervention Protocol for
Chemotherapy Induced Neutropenia and the result shows that patients undergoing myelosuppressive
chemotherapy are at risk of developing neutropenia which may lead to lifethreatening
infections that may quickly lead to sepsis, and death Severe neutropenia and febrile
neutropenia are therefore major causes of morbidity, treatment interruptions and dose reductions
in patients undergoing chemotherapy In addition to clinical impact, the economic impact of
neutropenia is considerable. Myelo-suppressive chemotherapy is commonly associated with
neutropenia, resulting in severe infections, treatment delays and, ultimately, adversely affecting
patients’ outcome (7)
PROBLEM STATEMENT
“A Study to assess the effect of Structured teaching programme on knowledge of patients with
Acute Myeloid Leukemia on Chemotherapy schedule , its Side effects and Management at a
tertiary cancer center.”
Key words -Structured teaching programme, Acute myeloid leukemia, Chemotherapy schedule,
side effects
Aim-To assess the effect of structured teaching on knowledge of patients with Acute Myeloid
Leukemia on Chemotherapy schedule, Side effects and its Management.
OBJECTIVES OF THE STUDY
1. To assess the knowledge regarding chemotherapy, its side effects and its management in
patients with Acute Myeloid Leukemia in experimental and control group
2. To assess the effect of structured teaching programme on chemotherapy, its side effects and its
management in patients with AML in experimental and control group 3. To find the association between knowledge scores and selected demographic variables of
patients with Acute Myeloid leukemia
ASSUMPTIONS
1. All participants receiving cytarabine and daunomycine chemotherapy treatment are at
risk of developing side effects.
2. Structured teaching programme is accepted method of teaching.
3. Structured teaching programme may improve the knowledge scores.
4. Knowledge will vary from person to person.
HYPOTHESIS
H0- There will be no significant difference in knowledge score related to chemo schedule and its
management in acute myeloid leukemia patients post structured teaching programme.
The finding of the study will highlight the existing knowledge of patients with AML
receiving chemotherapy
Structured teaching programme on AMl Chemotherapy schedule, side effects and its
management could be used to educate the patients.

RESEARCH METHODOLOGY
In this study the researcher is going to assess the knowledge of patients related to AML
chemotherapy protocol its side effects and its management. The subjects would be adult AML
patients those are receiving chemotherapy in TMH, there would be 2 groups experimental and
control group. After assessment of patients if those are meeting the inclusion criteria after
consent Pre test will be taken for the patients from the both the groups. The structured teaching
will be provided to the experimental group samples at the same day. The post test will be
conducted for the both the groups on 7 th day in the same setting.
I-Research Aproach- Quantitative approach.
II- Design of the study -Nonrandomized trial (quasi-experiment)
2 group pre test - post test.
III- Setting – Tertiary cancer center in Mumbai TMH- OPD and Inpatients.
IV- Research variables
Independent variable – structured teaching programme.
Dependent variables – Knowledge of patients on chemotherapy schedule, side effects and
its management.
Demographic variables- In this study the demographic variables are Age, Gender,
Educational status, Family income, Diagnosis, and informant

V-Target population –
Patients diagnosed and receiving treatment for AML

VI- Sample - patients planned and receiving Chemotherapy for AML who fulfills the inclusion
criteria

VII- Sample size – 60
30 each will be in control and Experimental group.

VIII - Sampling technique – Convenient Sampling

IX- Duration- 6 months

X-Criteria for Sample Selection:
Inclusion criteria –
Age above 18 years & diagnosed with AML
Patients Planned for 3+7 protocol chemotherapy
Patients receiving 3+7 protocol chemotherapy
Patients able to read, write Hindi/ English or Marathi.
Registered with TMH.
Exclusion criteria –
Relapsed AML
Paediatric patients
Patients those are not willing to participate.
Patient on maintenance
Palliative patients

Tool & Technique:
Tool:
1. Structured knowledge questionnaire
3. Structured teaching programme
Technique:. Self Report technique using questionnaire
Data collection time – Six weeks at Tata Memorial Hospital
Description of the tool-
Investigator will prepare a questionnaire according to the objectives
Section A- Patient information- Demographic profile like, Age,Gender, Education, Family
income, Occupation, diagnosis, Chemotherapy and Informant.
Section B – (I)Knowledge regarding AML
(II)Knowledge regarding chemotherapy Schedule in AML
(III)Knowledge regarding side effects and its management
 
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