| CTRI Number |
CTRI/2026/01/100419 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational Intervention Pretest & post test] |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Educational Intervention on Knowledge, Attitude, and Practice Regarding Breast Cancer and Breast Self-Examination among College Students of Imphal, Manipur: A Quasi-Experimental Study |
|
Scientific Title of Study
|
Effectiveness of Educational Intervention on Knowledge, Attitude, and Practice Regarding Breast Cancer and Breast Self-Examination among College Students of Imphal, Manipur: A Quasi-Experimental Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jalka Devi Subba |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Science, Imphal |
| Address |
Community Meedicine Department
RIMS
Imphal West
Imphal West
MANIPUR
795004
India |
| Phone |
08327467802 |
| Fax |
|
| Email |
jalka_ms@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Sanayaima Devi |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Science, Imphal |
| Address |
Community Medicine Department
Imphal West
Manipur
India
Imphal West
MANIPUR
795004
India |
| Phone |
7085351488 |
| Fax |
|
| Email |
drsanahj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jalka Devi Subba |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Science, Imphal |
| Address |
Community Medicine Department
Regional Institute of Medical Science
Imphal West
Manipur
India
Imphal West
MANIPUR
795004
India |
| Phone |
08327467802 |
| Fax |
|
| Email |
jalka_ms@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Jalka Devi Subba |
| Address |
Community Medicine Department
RIMS
Imphal West
Manipur
India
Pin 795004
India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jalka Devi Subba |
Shree Shree Gourgobind Girls college |
Khurai Sajor Leikai
Imphal East
Manipur
India
Imphal East
MANIPUR |
08327467802
jalka_ms@yahoo.com |
| Dr Jalka Devi Subba |
T.S Paul Manipur Women’s College |
Mongsangei
Imphal West
Manipur
India
Imphal West
MANIPUR |
08327467802
jalka_ms@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH ETHICS BOARD RIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Effectiveness of Educational Intervention on Knowledge, Attitude, and Practice Regarding Breast Cancer and Breast Self-Examination Among College Students of Imphal, Manipur: A Quasi-Experimental Study |
Health education will be conducted over 2 months and will include an awareness session followed by a short-animated video on breast self-examination. At the end of the session, an information pamphlet will be provided to each participant. The education session will be divided into two sections: The First section will be a pretest; second section will be followed by education intervention on Breast Cancer and Breast Self-Examination. |
| Comparator Agent |
Not applicablde |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Students aged 18 years and above |
|
| ExclusionCriteria |
| Details |
Those who are absent or sick on the first day of data collection or during the intervention program will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowledge, Attitude and Practice on Breast cancer and Breast self-examination |
Day 0, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="424"
Sample Size from India="424"
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)
|
27/03/2026 |
| 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 Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
This quasi-experimental study investigates the effectiveness of an educational intervention on breast cancer awareness and breast self-examination (BSE) practices among college students in Imphal, Manipur. Breast cancer is a leading cause of death among women in India, with increasing incidence and low survival rates, especially in low-resource regions like Northeast India. The study targets young women as key agents for the dissemination of health education. Two women’s colleges will be randomly selected one as the intervention group and the other as the control group with 94 students in each. Baseline data on knowledge, attitude, and practices (KAP) regarding breast cancer and BSE will be collected using a structured questionnaire. The intervention group will receive two educational sessions: a lecture with group discussion and an animated video with pamphlet distribution. A post-intervention assessment will follow two months later. Data will be analyzed using SPSS software vs 26. The study will assess changes in KAP scores using appropriate statistical tests. Ethical clearance, informed consent, and data confidentiality protocols will be strictly followed. Ultimately, the findings aim to guide low-cost, scalable public health strategies for early breast cancer detection in resource-limited settings. |