Effectiveness and Impact of the Lived Experience Cancer Awareness Campaign on Screening Participation

Effectiveness and Impact of the Lived Experience Cancer Awareness Campaign on Participation in the Existing Cancer Screening Programs [Oral, Breast and Cervical] Among the Rural Population in Villupuram District, Tamil Nadu

This study will be conducted as a parallel-arm, open-label, randomized controlled trial (RCT) to evaluate the effectiveness and impact of the Lived Experience Communication Campaign (LECC) on cancer screening participation rates [oral, breast and cervical cancer] compared to the usual standard awareness campaign across selected rural population in Villupuram district, Tamil Nadu.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Oral Cancer; Cervical Cancers
• Intervention / Treatment: Behavioral: Lived experience video campaign

Detailed Description

The Access Cancer Care India (ACCI) project is aimed at designing and evaluating an evidence-based multi-level strategy tailored to the local health system to enhance access to early detection and care continuum for oral, breast, and cervical cancers among rural populations in India, who are socioeconomically disadvantaged and vulnerable to huge inequity in cancer care.

Pre-intervention phase:

The pre-intervention assessment was conducted in four blocks (Vanur, Mailam, Vikravandi, Kanai) in Viluppuram District, Tamil Nadu, between August 2023 and July 2024 to understand the barriers and challenges rural men and women face in accessing cancer early detection care continuum using various methods.

1. Questionnaire survey of breast, cervical, and oral cancer patients and the general population
2. Focus group discussions with the general population and community health workers
3. In-depth interviews with key informants
4. Capacity assessment The results of the preintervention highlighted that fear, stigma, limited accessibility to screening, miscommunication and lack of family support were vital barriers that influenced cancer care access in Tamil Nadu. Thus, we decided to design and implement evidence based cultural relevant intervention, pilot test and evaluate them. In order to target the component of fear, stigma and accessibility issues, we decided to design and implement a Lived life communication campaign and test it as an RCT across selected blocks of Tamil Nadu. The rationale for proposing a parallel-arm RCT for this intervention is to assess its effectiveness specifically within the Indian context. While the "lived experience" campaign has been successfully implemented in other Asian populations, its impact in India remains untested. A parallel-arm RCT design enables comparison across the intervention and control arm on specific screening program outcomes. This approach ensures a comprehensive assessment of the intervention's effectiveness in improving screening uptake among the target population. The findings will provide robust evidence to either validate or improve the intervention, tailoring it to the unique needs of the Indian setting. This study evaluates the effectiveness of the Lived Experience Communication Campaign (LECC) in increasing participation in cancer screening programs for oral, breast, and cervical cancer among rural populations in Villupuram district, Tamil Nadu. Conducted as a parallel-arm, open-label, randomized controlled trial (RCT), the study compares LECC to standard awareness campaigns. Randomisation was at the level of the block using cointoss, where Mailam block serves as the intervention site, while Vanur block serves as the control. Eligible participants (men and women aged 30-59 years without prior cancer diagnoses or recent screenings) will be randomly selected using systematic sampling. The intervention comprises a culturally relevant two-minute awareness video featuring personal survivor narratives, delivered door-to-door by community health workers. Standard awareness campaigns are conducted in the control arm. Baseline data on cancer screening participation is collected from healthcare records. Follow-up assessments are conducted monthly for six months, measuring screening participation rates and other program indicators. Evaluation follows the RE-AIM framework, examining effectiveness, feasibility, and acceptability. Results will inform future policy decisions on implementing lived experience campaigns to enhance cancer screening uptake in India.

• Study Type: Interventional
• Enrollment (Actual): 1120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600020
      • Adyar cancer institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Men and women aged 30-59 years
• No prior diagnosis of cervical, breast, or oral cancer.
• Have not undergone screening for the above cancers in the last 1 year
• Provide informed consent to participate

Exclusion Criteria:

• Individuals with a previous history of any cancer
• Individuals with severe cognitive impairments that prevent comprehension of study materials
• Participants unwilling to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Participants in the selected villages will be shown a two-minute video developed specifically for the Lived Experience Communication Campaign in addition to usual awareness they receive for cancer screening mobilisation. The video will feature personal narratives from cancer survivors and local leaders emphasizing the importance of early detection and screening.	Behavioral: Lived experience video campaign; Participants in the selected villages will be shown a two-minute video developed specifically for the Lived Experience Communication Campaign in addition to usual awareness they receive for cancer screening mobilisation. The video will feature personal narratives from cancer survivors and local leaders emphasizing the importance of early detection and screening.
No Intervention: Control arm; Participants will receive standard cancer awareness campaigns conducted by community health workers as per existing healthcare practices. No additional materials or interventions will be provided beyond routine awareness programs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening Participation Rate	The proportion of eligible participants who visited a healthcare center for cervical, breast, or oral cancer screening within one month of the intervention (or usual care in the control group).	1 month after the participation
Invitation coverage in both arms	The proportion of eligible individuals living in the intervention and control villages covered through invitations for cancer screening.	6 months
Examination coverage in both arms	The proportion of individuals eligible for screening who participated in the screening program.	6 months
Further assessment coverage in both arm	The proportion of individuals who participated in the cancer screening program requiring further assessment.	6 months
Detection of cancers in both arms	The proportion of individuals eligible for screening who are diagnosed with cancers.	6 months
Treatment referral in both arms	The proportion of individuals eligible for screening who are referred for treatment to higher centres.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation research outcomes - Reach	Proportion of eligible men and women who received the intervention.	6 months
Implementation research outcomes - Effectiveness	Proportion of eligible men and women who agreed to participate in the existing cancer screening program.	6 months
Implementation research outcomes - Acceptability	Proportion of eligible men and women who find the intervention (Lived experience campaign video) to be acceptable.	6 months

Collaborators and Investigators

• Sponsor: International Agency for Research on Cancer
• Collaborators: Adyar Cancer Institute, WIA, Chenni, India; Department of Public Health and Preventive Medicine (DPH & PM), Chennai, India
• Investigators: Principal Investigator: T.S. Selvavinayagam, MD, Department of Public Health and Preventive Medicine; Principal Investigator: Jerard Maria Selvam, National Health Mission-Tamil Nadu; Principal Investigator: K. Krishnaraj, Department of Public Health and Preventive Medicine; Principal Investigator: Vidhya Viswanathan, Department of Public Health and Preventive Medicine; Principal Investigator: N.V. Vani, PhD, Cancer Institute (WIA), Chennai; Principal Investigator: R. Swaminathan, PhD, Cancer Institute (WIA), Chennai, India

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2025
• Primary Completion (Actual): January 31, 2026
• Study Completion (Estimated): May 15, 2026

Study Registration Dates

• First Submitted: February 28, 2025
• First Submitted That Met QC Criteria: March 7, 2025
• First Posted (Actual): March 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cancer screening; Randomised control trial; Lived Experience Communication Campaign; Public Health intervention; Access Cancer Care India
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mouth Diseases; Stomatognathic Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Head and Neck Neoplasms; Genital Neoplasms, Female; Skin Diseases; Breast Diseases; Uterine Cervical Diseases; Uterine Neoplasms; Skin and Connective Tissue Diseases; Breast Neoplasms; Uterine Cervical Neoplasms; Mouth Neoplasms
• Other Study ID Numbers: IEC 22-05; MR/W023903/1 (Other Grant/Funding Number: Medical Research Council (MRC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No