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CTRI Number  CTRI/2025/03/082195 [Registered on: 12/03/2025] Trial Registered Prospectively
Last Modified On: 10/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Improving Cancer Awareness and Screening in Tamil Nadu 
Scientific Title of Study   Strengthening Early Detection for Breast, Cervical, and Oral Cancers in Viluppuram District, Tamil Nadu – An Implementation Research Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CTRI/2022/09/045927 (Pre-intervention Protocol)  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R Swaminathan 
Designation  Associate Director 
Affiliation  Cancer Institute WIA 
Address  Dr S Krishnamurthi campus, Baghwan Adhinath Jain Complex, Room No: 47, Department of Epidemiology, Biostatistics and Cancer Registry No 38, Sardar patel road, Adyar

Chennai
TAMIL NADU
600036
India 
Phone  914422209150  
Fax  04424912085  
Email  r.swaminathan@cancerinstitutewia.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr R Swaminathan 
Designation  Associate Director 
Affiliation  Cancer Institute WIA 
Address  Dr S Krishnamurthi campus, Baghwan Adhinath Jain Complex, Room No: 47, Department of Epidemiology, Biostatistics and Cancer Registry No 38, Sardar patel road, Adyar

Chennai
TAMIL NADU
600036
India 
Phone  914422209150  
Fax  04424912085  
Email  r.swaminathan@cancerinstitutewia.org  
 
Details of Contact Person
Public Query
 
Name  Dr R Swaminathan 
Designation  Associate Director 
Affiliation  Cancer Institute WIA 
Address  Dr S Krishnamurthi campus, Baghwan Adhinath Jain Complex, Room No: 47, Department of Epidemiology, Biostatistics and Cancer Registry No 38, Sardar patel road, Adyar

Chennai
TAMIL NADU
600036
India 
Phone  914422209150  
Fax  04424912085  
Email  r.swaminathan@cancerinstitutewia.org  
 
Source of Monetary or Material Support  
Medical Research Council UK  
 
Primary Sponsor  
Name  Medical Research Council (MRC) 
Address  Polaris House, North Star Avenue, Swindon, SN2 1FL  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
International Agency for Research on Cancer  25 avenue Tony Garnier, CS 90627, 69366 LYON CEDEX 07, France  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr R Swaminathan   Cancer Institute WIA   Dr S Krishnamurthi campus, Baghwan Adhinath Jain Complex, Room No: 47, Department of Epidemiology, Biostatistics and Cancer Registry No 38, Sardar patel road, Adyar Chennai 600 036
Chennai
TAMIL NADU 
04422209150

r.swaminathan@cancerinstitutewia.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Directorate of Public Health and Preventive Medicine  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Cancer Awareness and Screening  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cancer awareness campaign through a video showing Lived Screening Experiences. (Lived Experience Cancer Communication Campaign)  3,000 adults (men and women 20 to 59 years old) in randomly selected villages in the intervention block (Mailam Block, Viluppuram district, Tamil Nadu). 
Comparator Agent  Standard Cancer awareness campaign by flipchart method  3,000 adults (men and women 20 to 59 years old) in randomly selected villages in the Control block (Vanur Block, Viluppuram district, Tamil Nadu) 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  All adults aged 20-59 in the chosen intervention/control villages will be included in the study. 
 
ExclusionCriteria 
Details  Individuals below 20 and above 60 years of age.
Individuals with cognitive impairment.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improved community engagement and increased participation in cancer screening programs   Intervention period - 12 months
Post-intervention assessment – 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Assess the feasibility and acceptability of the intervention among healthcare workers and community members.
Identify barriers and facilitators to effective implementation of the intervention
Evaluate the costing of the intervention.
Assessment of system readiness and capacity to sustain and scale up the intervention.
 
Intervention period - 12 months
Post-intervention assessment – 6 months
 
 
Target Sample Size   Total Sample Size="6000"
Sample Size from India="6000" 
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)   01/04/2025 
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="1"
Months="6"
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  

Tamil Nadu recorded an estimated 90,000 new cancer cases in 2023, with breast, cervical, and oral cancers being the most common. Limited access to cancer care in rural areas leads to delayed diagnoses and lower survival rates. The Access Cancer Care India (ACCI) project aims to enhance early detection and treatment through evidence-based interventions tailored to the local healthcare system. A pre-intervention assessment was conducted in four blocks (Mailam, Vanur, Vikravandi, and Kanai) of the Viluppuram district and identified key barriers to cancer screening, including fear, stigma, limited accessibility, and lack of family support. Surveys, focus group discussions, and in-depth interviews informed the joint development of an evidence-based strategy with the key stakeholders.

One major intervention in this study is the Lived Experience Communication Campaign (LECC), designed to assess its impact on participation in existing cancer screening programs among the rural population of Viluppuram district, Tamil Nadu. A field intervention trial will be conducted in villages within a 10 km radius of public healthcare facilities in Mailam (intervention block) and Vanur (control block). The intervention consists of a video showcasing Lived cancer screening experiences, which will be shown to 3,000 adults (men and women aged 20–59 years). Community health workers (CHWs) will facilitate the video using tablet computers during household visits. In the control block, cancer awareness activities will follow the standard Flipchart-based campaign, also conducted by CHWs and targeting 3,000 adults in the same age group.

A list of all adults in the randomly selected villages will be compiled using CHW-maintained family registers and verified through household visits. Eligible participants will provide verbal consent before viewing the video. Each participant’s name will be recorded to track progress, and they will receive an invitation card for screening. The process will continue until the target sample size of 3,000 adults is reached. The same method will be used in the control block, except that participants will receive the routine standard campaign instead of the video intervention.

The video campaign follows the 5M framework for health communication, highlighting cancer screening as a simple and accessible routine check-up. Cancer screening rates will be monitored at baseline, during the intervention, and six months post-intervention. The study will be evaluated using a mixed-methods approach guided by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) and monitored for fidelity. A process evaluation will document implementation challenges and adaptations. This intervention aims to enhance cancer awareness and early detection rates for common cancers in rural Tamil Nadu. The findings will support scaling up the intervention across the state by assessing its effectiveness and identifying best practices.

 
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