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

NCT06874985 | Enrolling By Invitation DMC

• 2 other identifiers: IEC 22-05MR/W023903/1
• Study Type: interventional
• Target: 1,120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancers; Breast Cancer; Oral Cancer

Keywords

Lived Experience Communication Campaign; Randomised control trial; Cancer screening; Public Health intervention; Access Cancer Care India

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Implementation research outcomes - Reach

  6 months

• Implementation research outcomes - Effectiveness

  6 months

• Implementation research outcomes - Acceptability

  6 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

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.

Interventions

Lived experience video campaign BEHAVIORAL

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.

Intervention arm

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Agency for Research on Cancer: lead
• Adyar Cancer Institute, WIA, Chenni, India: collaborator
• Department of Public Health and Preventive Medicine (DPH & PM), Chennai, India: collaborator

Study Sites (1)

Adyar cancer institute

Chennai, Tamil Nadu, 600020, India

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Breast Neoplasms; Mouth Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Head and Neck Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Since cluster or individual randomization was not feasible due to the risk of contamination, a simple randomization strategy was employed at the block-level. A coin flip \[doe by the investigator team at IARC\] identified which block would receive the intervention (Mailam) and which would serve as the control (Vanur). However, all the baseline characteristics and demographics will be collected from both the participants in both villages and would be compared to ensure

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 13, 2025
• Study Start: May 5, 2025
• Primary Completion: September 15, 2025
• Study Completion: December 15, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-05

Locations

IN (1)