| CTRI Number |
CTRI/2025/10/096454 [Registered on: 24/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Demonstration of breast self examination] |
| Study Design |
Other |
|
Public Title of Study
|
effect of a Breast Examination Training Model on Women’s Ability to Perform Breast Self-Examination in a Rural Area of Anand District |
|
Scientific Title of Study
|
A study to assess effectiveness of self-prepared breast examination model among reproductive age group women in selected village of Anand district. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ekta Vikas Patel |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Nursing Sciences, Karamsad |
| Address |
Room no. 205, Institute of Nursing Sciences, Bhaikaka University, Karamsad
Anand
GUJARAT
388325
India |
| Phone |
08347433558 |
| Fax |
|
| Email |
ektapatel501@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ekta Vikas Patel |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Nursing Sciences, Karamsad |
| Address |
Room no. 205, Institute of Nursing Sciences, Bhaikaka University, Karamsad
GUJARAT
388325
India |
| Phone |
08347433558 |
| Fax |
|
| Email |
ektapatel501@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hiral Makwana |
| Designation |
M. Sc. Nursing Student |
| Affiliation |
Institute of Nursing Sciences, Karamsad |
| Address |
Classroom no. 206, Institute of Nursing Sciences, Bhaikaka University, Gokal Nagar, Karamsad, Anand, Gujarat
Anand
GUJARAT
388325
India |
| Phone |
918849389713 |
| Fax |
|
| Email |
hiralmakwana662@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructure support- Primary health center of Kavitha village, Borsad, Gujarat, India- 388545 |
|
|
Primary Sponsor
|
| Name |
Primary Health center Kavitha village |
| Address |
Kavitha, Ta- Borsad, Dist. Anand, Gujarat, India- 388545 |
| Type of Sponsor |
Other [Primary Health center, Kavitha village] |
|
|
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 |
| Sachin RPatel |
Kavitha Village |
Kavitha, Ta: Borsad, Dist. Anand
Pin code: 388545
Anand
GUJARAT |
9714868071
sachinpatel4118585@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaikaka University, Karamsad, Anand, Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Female volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Demonstration of breast self examination on self-prepared breast examination model |
The present study aims to evaluate the effectiveness of a self-prepared breast examination model in improving the knowledge, attitude, and practice regarding breast self-examination among reproductive-age women (21–35 years) in selected villages of Anand district, Gujarat. Breast cancer is the most common cancer among women globally, and early detection through BSE is a simple, cost-effective, and accessible method. However, awareness and regular practice of BSE remain inadequate, especially in rural areas. This true experimental study will involve 140 participants selected through random sampling and divided into experimental and control groups. Pre-test and post-test assessments will be conducted using structured questionnaires, attitude scales, and practice checklists. The intervention group will receive model-based education on BSE. The study aims to determine whether the educational model significantly improves women’s BSE knowledge and practice, thereby promoting early detection and prevention of breast cancer in the community. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Women age from 21 to 35 years.
2. Who are able to read, write and understand English or Gujarati.
3. Who are present during the data collection of study. |
|
| ExclusionCriteria |
| Details |
1. who are not willing to participate in the research study.
2. Female who are severely ill during data collection time.
3. Women how have attended the menopause by surgically or naturally.
4. Women who have ongoing oncological treatment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of the self-prepared breast examination model on knowledge, attitude and practice regarding breast self-examination among reproductive age group women. |
At baseline data and 7 days after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of the self-prepared breast examination model on knowledge, attitude and practice regarding breast self-examination among reproductive age of women of experimental and control group. |
At baseline data and 7 days after intervention |
| To identify the association between selected socio-demographic variables and practice of breast self-examination. |
At baseline data and 7 days after intervention |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
10/11/2025 |
| Date of Study Completion (India) |
16/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The present study aims to evaluate the effectiveness of a self-prepared breast examination model in improving the knowledge, attitude, and practice regarding breast self-examination among reproductive-age women (21–35 years) in selected villages of Anand district, Gujarat. Breast cancer is the most common cancer among women globally, and early detection through BSE is a simple, cost-effective, and accessible method. However, awareness and regular practice of BSE remain inadequate, especially in rural areas. This true experimental study will involve 140 participants selected through random sampling and divided into experimental and control groups. Pre-test and post-test assessments will be conducted using structured questionnaires, attitude scales, and practice checklists. The intervention group will receive model-based education on BSE. The study aims to determine whether the educational model significantly improves women’s BSE knowledge and practice, thereby promoting early detection and prevention of breast cancer in the community. |