| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sreelakshmy1674nc@sgnc.edu.in].
- 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.
- 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. |