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CTRI Number  CTRI/2025/11/097967 [Registered on: 24/11/2025] Trial Registered Prospectively
Last Modified On: 23/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Other 
Public Title of Study   Community-Based Intervention on Breast and Cervical Cancer Awareness, Screening Practice and Screening Uptake, among Rural Women in selected districts of West Bengal. 
Scientific Title of Study   Effectiveness of Community-Based Intervention on Breast and Cervical Cancer Awareness, Screening Practice and Screening Uptake, among Rural Women in selected districts of West Bengal: A Mixed Method Approach 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aparna Kundu 
Designation  Reader and PhD Student 
Affiliation  West Bengal Government College of Nursing, IPGMER and SSKM Hospital 
Address  Department of Obstetrical Nursing, Room No. 202, West Bengal Government College of Nursing, IPGME&R and SSKM Hospital,244 AJC Bose Road, Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  8900171571  
Fax    
Email  aparna.mconmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sinjita Dutta 
Designation  Associate Professor and Co Guide 
Affiliation  IPGMER and SSKM Hospital,Kolkata 
Address  Department of Community Medicine, IPGME&R and SSKM Hospital,244 AJC Bose Road, Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  9830470649  
Fax    
Email  sinjita@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Aparna Kundu 
Designation  PhD Student 
Affiliation  West Bengal Government College of Nursing, IPGMER and SSKM Hospital 
Address  Department of Obstetrical Nursing, Room No. 202, West Bengal Government College of Nursing, IPGME&R and SSKM Hospital,244 AJC Bose Road, Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  8900171571  
Fax    
Email  aparna.mconmpl2024@learner.manipal.edu  
 
Source of Monetary or Material Support  
Sub centers under Budge Budge II Block, Department of Health and Family Welfare, Government of West Bengal 
 
Primary Sponsor  
Name  Aparna Kundu 
Address  West Bengal Government College of Nursing, IPGMER and SSKM Hospital,244 AJC Bose Road, Kolkata-700020 
Type of Sponsor  Other [Self] 
 
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 Aparna Kundu  LB Dutta Rural Hospital  Room No-2,Department-NCD Clinic,LB Dutta Rural Hospital , Budge Budge II Block, Muchisa
South Twentyfour Parganas
WEST BENGAL 
8900171571

aparna.mconmpl2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGME&R Research Oversight Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy women without breast and cervical cancer  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Teaching About Breast and Cervical cancer  Awareness Camp, Telephonic Interaction, Leaflet  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. Rural Women aged 30-65 years who can speak in Bengali and Hindi.
2. Women who have not done regular screening for both cervical and breast cancer.
 
 
ExclusionCriteria 
Details  1. Rural Women who are critically ill.
2. Women with immunosuppressant drugs.
3. Rural Women diagnosed with cervical cancer or breast cancer.
4. Within 6 weeks of delivery or abortion.
5. Pregnant women.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Increase the number of breast and cervical cancer screenings, BSE, CBE and mammography for breast cancer, Pap smear for cervical cancer.  The screening record for breast and cervical cancer will be assessed at baseline,4 weeks and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Increase the practice of screening for breast and cervical cancer.
2. Increase the reporting of breast and cervical cancer at health facilities.
3. Increase the number of referral cases of breast and cervical cancer. 
1 year 
 
Target Sample Size   Total Sample Size="412"
Sample Size from India="412" 
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)   29/12/2025 
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="3"
Months="0"
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  

This is a mixed-method study to assess the Effectiveness of Community-Based Intervention on Breast and Cervical Cancer Awareness, Screening Practice, and Screening Uptake, among Rural Women in selected districts of West Bengal. In the qualitative phase, Focus Group Discussion(FGD) will be done among the community health workers and rural women separately to identify barriers and facilitators of breast and cervical cancer screening. A total of 6-8 FGDs is planned. Based on the facilitators and barriers, a community-based intervention will be developed. Before the implementation of the community-based intervention, rural women will be assessed for awareness, screening practice, and screening uptake of breast and cervical cancer. Awareness will be assessed using the AWACAN (Standardized Tool), and practice will be evaluated using a checklist. The community-based intervention will be implemented for the sample through an awareness camp, by distributing teaching materials in the local language. One to interaction after the community-based intervention, awareness, screening practice, and screening uptake will be assessed to identify the effect of the Community-Based Intervention at one month and  3 months. To assess the screening uptake, medical records of the women will be checked for the Clinical Breast Examination(CBE), and mammography for breast cancer screening, and Visual Inspection (VIA) and Pap smear for cervical cancer screening up to one year. These screening tests the women will do for screening as per their age requirement.

 
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