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CTRI Number  CTRI/2025/07/091609 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 23/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Quasi-Experimental Study (Pre-test/Post-test design)]  
Study Design  Other 
Public Title of Study   Impact of Health Education on Awareness and Practice of Breast Self-Examination: A Study Among Female Staff in a Medical College in Dakshina Kannada 
Scientific Title of Study   Effectiveness of an educational intervention in knowledge, attitude, and practice towards Breast Self-Examination among female non-teaching staff of a medical college in Dakshina Kannada: A Quasi-Experimental Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gopika J 
Designation  Senior Resident 
Affiliation  Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, India 
Address  Department of Community Medicine, Kasturba Medical College Mangalore, Lighthouse hill road, Hampankatta, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  8281171734  
Fax    
Email  j.gopika@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Rekha T 
Designation  Professor 
Affiliation  Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Karnataka, Manipal, India 
Address  Department of Community Medicine, Kasturba Medical College, Mangalore, Lighthouse Hill Road, Hampankatta, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9449082214  
Fax    
Email  rekha.thapar@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Rekha T 
Designation  Professor 
Affiliation  Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Karnataka, Manipal, India 
Address  Department of Community Medicine, Kasturba Medical College, Mangalore, Lighthouse Hill Road, Hampankatta, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9449082214  
Fax    
Email  rekha.thapar@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Karnataka, Manipal, 576 104, India 
 
Primary Sponsor  
Name  Dr Gopika J 
Address  Department of Community Medicine, Kasturba Medical College Mangalore, Lighthouse hill road, Hampankatta, Mangalore, Karnataka, India - 575001 
Type of Sponsor  Other [Self Funded] 
 
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 Gopika J  Kasturba Medical College Mangalore  Department of Community Medicine, Kasturba Medical College, Mangalore, Lighthouse Hill Road, Hampankatta, Mangalore
Dakshina Kannada
KARNATAKA 		 8281171734

j.gopika@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Kasturba Medical College,Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy females between the ages of 20 and 60 years.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Health Education  The intervention consists of a single, organized educational session with live demonstrations, videos, and visual aids that is held in small groups. Important subjects like breast cancer awareness, risk factors, symptoms, the value of early detection, and the proper way to perform breast self-examination (BSE) are covered. The session is held in both Kannada and English. The interactive workshop includes a question-and-answer period to clear up participant queries and concerns.  
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. Female non-teaching staff aged 20–60 years.
2. Currently employed at KMC or MCODS, Mangalore.
3. Willing to provide informed consent.
 
 
ExclusionCriteria 
Details  1. Those with a prior history of breast cancer or who have undergone mastectomy
2. Pregnant/Lactating Mothers
3. Currently on long-term medical leave or not available during the study period.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in knowledge, attitude, and practice (KAP) scores regarding breast self-examination (BSE) among participants from baseline to 3 months post-intervention.  Baseline, 3 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Retention of knowledge, attitude, and practice scores   3 months post-intervention 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   22/08/2025 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   The study titled “Effectiveness of an Educational Intervention in Knowledge, Attitude, and Practice Towards Breast Self-Examination Among Female Non-Teaching Staff of a Medical College in Dakshina Kannada” focuses on bridging the knowledge gap regarding breast cancer and the noninvasive screening method of self-breast examination. This study focuses on assessing how well a health education session improves the knowledge, attitude, and practice (KAP) of female non-teaching staff members at a Dakshina Kannada medical college regarding breast self-examination (BSE). Although BSE is an easy and inexpensive way to detect breast cancer early, its frequent use and awareness are still low.

About three hundred female employees between the ages of twenty and sixty will participate in this quasi-experimental study. A questionnaire measuring the participants’ baseline knowledge, attitude, and present BSE habits will be given to them to fill out initially. After that, they will participate in a single interactive educational session that consists of live demonstrations, visual aids, and questions and answers. Participants will be reassessed right away and again after three months to assess any changes. Through increased awareness and self-assurance in doing BSE on a regular basis, the study seeks to empower women and encourage early detection. 

The data collected will be analysed to assess the immediate changes in knowledge and attitude pre- and post-test as well as their retention of knowledge post 3 months. The study anticipates that following the educational intervention, participants’ knowledge, attitudes, and practices surrounding breast self-examination will significantly improve. It anticipates better self-reported BSE practices at the 3-month follow-up, as well as greater awareness and more favorable attitudes. 
 
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