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CTRI Number  CTRI/2025/07/091289 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 17/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of health empowerment programme on knowledge,attitude and practice regarding prevention of gynaecological cancers among tribal women  
Scientific Title of Study   Effect of health empowerment programme on learning outcome regarding prevention of gynaecological cancers among tribal women – A Mixed method approach 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SREELAKSHMY U R 
Designation  PhD Scholar 
Affiliation  NITTE Usha Institute Of Nursing SCiences 
Address  NITTE Usha Institute Of Nursing Sciences NITTE Deemed to be University Mangalore
NITTE Usha Institute Of Nursing Sciences NITTE Deemed to be University Mangalore, 575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  8136876888  
Fax    
Email  sreelakshmy1674nc@sgnc.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr NEETHA KAMATH 
Designation  PROFESSOR 
Affiliation  NITTE Usha Institute Of Nursing SCiences 
Address  Department of community Health Nursing NITTE Usha Institute Of Nursing Sciences NITTE Deemed to be University Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845472309  
Fax    
Email  neethakamath@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr LIJA R NATH 
Designation  PROFESSOR 
Affiliation  Sree Gokulam Nursing College 
Address  VICE PRINCIPAL Sree Gokulam Nursing College Venjaramoodu

Thiruvananthapuram
KERALA
695607
India 
Phone  9947367686  
Fax    
Email  lija475nc@sgnc.edu.in  
 
Source of Monetary or Material Support  
NITTE Usha Institute of Nursing Sciences, Nitte Deemed to be university, Manglore pin 575018 
 
Primary Sponsor  
Name  SREELAKSHMY U R 
Address  PhD Scholar NITTE Usha Institute Of Nursing Sciences Mangalore 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SREELAKSHMY U R  Sree gokulam medical college and research foundation  Department of medical surgical nursing, Sree gokulam medical college campus, alanthara , venjaramoodu pin 695607
Thiruvananthapuram
KERALA 
8136876888

sreelakshmy1674nc@sgnc.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTE, SREE GOKULAM MEDICAL COLLEGE AND RESEARCH FOUNDATION, VENJARAMOODU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  TRIBAL WOMEN BETWEEN THE AGE GROUP 18 TO 60 YEARS 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Haalth empowerment programme   Health empowerment programme is an awareness package prepared by the investigator which comprises of overview of the disease, incidence, causes, risk factors, signs and symptoms, early detection, medical and surgical treatment of gynecological cancer and breast cancer and its prevention. 
Comparator Agent  No health empowermrnt programme   No Health empowermenr programme to control group 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  The women in the age group of 18 to 60 years.
The women who willing to participate in the study
Women who are living in tribal settlements of Kuttichal Panchayath in Trivandrum District.
The women who are available at the time of data collection
 
 
ExclusionCriteria 
Details  women who are deaf and dumb
women who are mentally retarded or with cognitive impairment
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
knowledge, attitude and practice regarding prevention of gynecological cancer   knowledge, attiude and practice regarding prevention of gynecological cancer will be assessed one week, and after three months after the health empowermnent teaching programme 
 
Secondary Outcome  
Outcome  TimePoints 
nil   nil 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
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)   01/08/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sreelakshmy1674nc@sgnc.edu.in].

  6. For how long will this data be available start date provided 01-08-2027 and end date provided 01-08-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Women in India represent an especially vulnerable group for cancer due to the low priority to health, and barriers in access to healthcare among them for various reasons. The tribal population is an integral part of India’s social diversity and has the second largest concentration after that of the African continent. To prevent neglect or poor adherence of cancer treatment due to lack of correct knowledge and presence of incorrect information, there is a need to find out all these myths and misconceptions present in the society. Therefore, this study will be conducted to explore the myths and beliefs regarding cancer and its treatment and the effectiveness of a health empowerment programme on learning outcome regarding prevention of gynaecological cancers  among women in a selected tribal area in Trivandrum. A mixed method sequential exploratory design will be used for the study. The study will be conducting in the tribal area of Kuttichal Panchayat, Nedumangad Taluk, Trivandrum district. Non probability purposive sampling technique will be used. Initially  the researcher will conduct an open ended semi structured interview to identify the myths and beliefs regarding cancer and its treatment. The data collection  will be carried out in depth by the researcher herself with participants until data saturation is reached. After the qualitative phase, the structured knowledge questionnaire, attitude scale and preventive practice checklist  will be administered to participants  who meet inclusion criteria to both experimental and control group. The health empowerment programme will be administered to only to experimental group on the first day of data collection  and the first post-test will be conducted one week after  intervention and second post-test will be conducted after 3 months for experimental and control group.

 
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