FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/10/037332 [Registered on: 14/10/2021] Trial Registered Prospectively
Last Modified On: 25/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   STUDYING THE USEFULNESS OF AN ELECTRONICALLY SHARED EDUCATIONAL VIDEO ON THE EXISTING KNOWLEDGE, ATTITUDE AND PRACTICES OF BREAST CANCER AWARENESS AND BREAST SELF EXAMINATION AMONGST EDUCATED WOMEN OF DELHI. 
Scientific Title of Study   ASSESSING EFFECTIVENESS OF A VIDEO BASED INTERVENTION ADMINISTERED ACROSS VIRTUAL PLATFORM ON THE EXISTING KNOWLEDGE,ATTITUDE AND PRACTICES OF BREAST CANCER AWARENESS & BREAST SELF EXAMINATION AMONG LITERATE WOMEN IN METROPOLITAN CITY OF DELHI:A QUASIEXPERIMENTAL COMMUNITY BASED INTERVENTIONAL STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suhani 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi. 
Address  Office of Department of Surgical Disciplines, CMET Teaching Block, All India Institute of Medical Sciences, New Delhi.
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, 110029
South West
DELHI
110029
India 
Phone  9868397697  
Fax    
Email  drsuhani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suhani 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi. 
Address  Office of Department of Surgical Disciplines, CMET Teaching Block, All India Institute of Medical Sciences, New Delhi.
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
South West
DELHI
110029
India 
Phone  9868397697  
Fax    
Email  drsuhani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Muthineni Rajashekhar Rao 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi. 
Address  Room no 19,Ground Floor, Masjid Moth Campus, All India Institute of Medical Sciences, New Delhi.
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
South West
DELHI
110049
India 
Phone  9063558073  
Fax    
Email  rajashekharrao4362@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences New Delhi 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
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 Suhani  All India Institute of Medical Sciences, New Delhi.  Office of the Department of Surgical Disciplines, 1st floor, CMET Teaching block, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, 110029
South West
DELHI 
9810534358

drsuhani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POSTGRADUATE RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Breast cancer 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  educational video  An educational video will be administered of approximately 15-20 minutes duration that the participant will be instructed to watch twice. Follow-up questionnaire will be shared 6-8 weeks and 12-16 weeks after watching the video. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  School teachers aged 25 years or more
Graduate or beyond
Individuals with accessibility to the virtual platform (email and/or Whatsapp) that can receive
and respond to the questionnaires and access the video-based training module
Individuals residing within the confines of the National Capital Territory of Delhi
Women consenting to participate in the study. 
 
ExclusionCriteria 
Details  Individuals who have not finished or failed to submit once they finish, any one of the
questionnaires provided.
Participants who have not accessed the video-based teaching module as advised during the
study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the effectiveness of a structured video-based teaching module provided across a virtual
platform on the existing knowledge and attitude on breast cancer awareness and practices of breast
self-examination in literate women residing in the metropolitan city of Delhi. 
0 weeks, 6-8 weeks, 12-16 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To study the existing knowledge, attitude and practices of breast cancer awareness and breast self
examination in literate women residing in the metropolitan city of Delhi. 
0 weeks, 6-8 weeks, 12-16 weeks 
To study the factors hindering the practice of breast self-examination in literate women residing in
the metropolitan city of Delhi. 
0 weeks, 6-8 weeks, 12-16 weeks 
 
Target Sample Size   Total Sample Size="103"
Sample Size from India="103" 
Final Enrollment numbers achieved (Total)= "181"
Final Enrollment numbers achieved (India)="181" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/11/2021 
Date of Study Completion (India) 02/11/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/11/2022 
Estimated Duration of Trial   Years="2"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Breast cancer is the most commonly diagnosed cancer among women, both across the world and in India. Increasing prevalence along with advanced stage at presentation remain the key areas of concern with respect to this disease in our country. A programmatic strategy to decreasing the cancer burden in a country usually involves two key approaches, “screening” and “clinical down-staging (early diagnosis)”. A combination of the two, rather than just one of them, is aspired for by the contemporary health care system.

Screening for breast cancer usually employs three key modalities: mammography, breast self-examination and clinical breast examination. While screening with mammography is in place in developed countries like the US, these may not be cost effective for a large population base in a developing country with resource constraints like ours. In such scenarios, early detection by the women herself using breast self examination remains a viable option.

Good levels of awareness with respect to signs and symptoms of breast cancer and the regular practice of breast self-examination can help the individuals who are symptomatic to access health care facilities earlier. The existing studies in Indian population with respect to the knowledge, attitude and practices regarding breast cancer awareness and breast self-examination indicate a need for improvement. This present study aims to study the effect of a video-based intervention that can be shared across a virtual platform on the existing knowledge, attitude and practices of breast cancer awareness and breast self-examination amongst the literate women residing in the metropolitan city of Delhi.

 
Close