| CTRI Number |
CTRI/2025/07/092124 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Awareness about Self-Breast Examination among women participants in an Urban Slum Community of Delhi |
|
Scientific Title of Study
|
Impact of Training on Knowledge and Skill Regarding Self-Breast Examination among Women in an Urban Slum Community in Delhi : A Quasi Experimental Study |
| Trial Acronym |
SBE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vanshika |
| Designation |
3rd year MBBS Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 56, Sanjeevani Hostel, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
New Delhi DELHI 110002 India |
| Phone |
8950705758 |
| Fax |
|
| Email |
vsj317005@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shivani Rao |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room Number-343, Department of Community Medicine, Pathology Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
New Delhi DELHI 110002 India |
| Phone |
9650729724 |
| Fax |
|
| Email |
shivani.idsp@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shivani Rao |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room Number-343, Department of Community Medicine, Pathology Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
New Delhi DELHI 110002 India |
| Phone |
9650729724 |
| Fax |
|
| Email |
shivani.idsp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur Shah Zafar Marg, near Delhi Gate, Balmiki Basti, New Delhi, 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2, Bahadur Shah Zafar Marg, New Delhi-110002 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Shivani Rao |
Maulana Azad Medical College |
Urban Health Centre under the department of Community Medicine, Delhi Gate, Daryaganj, New Delhi. New Delhi DELHI |
9650729724
shivani.idsp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Women Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Health Education Intervention. |
In this phase participants will be given health education and skill-based training in groups followed by a post-test. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Women of age above 20 years who have been residing in the study area for at least 6 months prior to study |
|
| ExclusionCriteria |
| Details |
1. Women who are terminally ill and need special care
2. Women who are immunocompromised
3. Women who have been diagnosed with Breast Cancer |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage change in knowledge and skill of self-breast examination among the women after training session. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of women with knowledge, attitude, and practice regarding self breast examination.
Association of knowledge, attitude, and practice regarding self-breast examination.
|
NIL |
|
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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)
|
18/08/2025 |
| 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="0" Months="5" 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
|
Breast cancer is a leading cause of cancer-related morbidity and mortality among women worldwide, especially in developing countries like India, where late detection is common due to low awareness. This quasi-experimental study aims to evaluate the impact of training on knowledge and skills related to Breast Self-Examination (BSE) among women living in an urban slum community in Delhi
The study’s primary objective is to assess changes in women’s knowledge and skills on performing BSE after a training session using a dummy breast model. Secondary objectives include measuring overall breast cancer knowledge and examining associations between knowledge, attitudes, practices regarding BSE, and socio-demographic factors.
The study will involve women over 20 years old from the Delhi Gate slum area, selected through systematic random sampling. Data collection includes pre- and post-training assessments through interviews and observation checklists. Training will involve health education via videos, presentations, and practical demonstrations with standardized models.
Expected outcomes include increased awareness and proficiency in BSE, identification of knowledge gaps, and understanding socio-demographic influences on BSE practices. The study seeks to empower women for early breast cancer detection, inform health education programs, and guide policy development for underserved populations. |