| CTRI Number |
CTRI/2025/12/098894 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
06/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [interventional] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Peer teaching to improve breast self-examination among students. |
|
Scientific Title of Study
|
A Study to Evaluate the Effectiveness of Peer Education on Knowledge and Practice of Breast Self-Examination among Undergraduate Students of a Selected College in Mangalore, Dakshina Kannada. |
| Trial Acronym |
not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms. Anusha |
| Designation |
Post graduate student |
| Affiliation |
yenepoya nursing college mangalore |
| Address |
Anusha C
MSc NUrsing
dept of obg nursing
derlakatte, Mangaluru
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
8884501349 |
| Fax |
|
| Email |
anushacanu9@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrJanet Miranda |
| Designation |
Associate professor and HOD |
| Affiliation |
yenepoya nursing college mangalore |
| Address |
Janet miranda
Associate professor and HOD
Dept of OBG
YNC mangaluru.
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9886933804 |
| Fax |
|
| Email |
janetmiranda@yenepoya.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Anusha c |
| Designation |
Post graduate student |
| Affiliation |
yenepoya nursing college mangalore |
| Address |
Anusha C
PG student
dept of obg
Yenepoya nursing college mangalore
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
8884501349 |
| Fax |
|
| Email |
anushacanu9@gmail.com |
|
|
Source of Monetary or Material Support
|
| yenepoya deemed to be university, Deralakatte
Mangaluru-575018
karnatak , india |
|
|
Primary Sponsor
|
| Name |
yenepoya deemed to be university |
| Address |
Deralakatte,Mnagaluru,Dakshinakannada,karanatak |
| Type of Sponsor |
Research institution |
|
|
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 |
| Anusha c |
University first grade college mangalagangothri |
Mangalore University
Konaje Mangaluru Dakshina Kannada KARNATAKA |
8884501349
anushacanu9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| YEC-3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
undergraduate female students aged 18-25 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
knowledge and practice about breast self examination |
The intervention consisted of a structured peer education program on breast self-examination (BSE). Selected peer educators were trained using a teaching module that included information on breast cancer awareness, the importance of early detection, and the correct steps of BSE. These trained peers then conducted interactive sessions for the participants, which included lectures, demonstrations, and visual aids to teach the correct technique of BSE. After the training session, participants were encouraged to practice BSE, and reinforcement was provided. A post-test assessment was conducted after one month to evaluate changes in knowledge and practice. |
| Comparator Agent |
Not applicable |
single arm -pre experimental no comparison |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
23.00 Year(s) |
| Gender |
Female |
| Details |
Female students who are 18 years of age or older and voluntarily consent to participate in the study
Female students who are able to understand and respond to the study instruments in English
|
|
| ExclusionCriteria |
| Details |
Those who had a history of breast cancer.
Students who have received prior formal training on breast self-examination
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of students correctly performing breast self-examination, assessed using a structured checklist |
Baseline (before intervention), 4 weeks after intervention (primary endpoint), and 8 weeks after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in students’ attitude and self-confidence toward performing breast self-examination. |
Day 0 (baseline) and Day 30 (one month post-intervention). |
|
|
Target Sample Size
|
Total Sample Size="63" Sample Size from India="63"
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)
|
21/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="11" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Breast cancer continues to be a major public health concern among Indian women, and early detection through Breast Self-Examination (BSE) can significantly reduce morbidity and mortality. Despite this, awareness and regular practice of BSE among young women, especially college students, remains inadequate. Peer education is an effective health-promotion strategy that utilizes trained students to teach and motivate their peers, creating a comfortable and relatable learning environment. This study aims to evaluate the effectiveness of a structured peer training program on improving the knowledge and practice of BSE among undergraduate female students in a selected college in Mangalore. The research adopts a pre-experimental one-group pre-test post-test design. During the study, selected peer educators will receive training on breast cancer awareness and BSE techniques. These peer educators will then conduct interactive teaching sessions and demonstrations for the participants. Knowledge will be assessed using a validated questionnaire, and BSE practice will be evaluated using an observational checklist before and after the intervention. The findings are expected to provide evidence on whether peer-led education can serve as a cost-effective and sustainable method to promote early detection behaviors among young women. The study also aims to support future health-promotion activities in educational institutions. |