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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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