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
|
|
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
|
|
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)â€. 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. |