| 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
|
|
|
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. |