Clinical trial NCT06874985: Effectiveness and Impact of the Lived Experience Cancer Awareness Campaign on Screening Participation
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cervical Cancers
Breast Cancer
Oral Cancer
Keywords: Lived Experience Communication Campaign
Randomised control trial
Cancer screening
Public Health intervention
Access Cancer Care India
Lead sponsor: International Agency for Research on Cancer
Sponsor class: OTHER
Collaborators: name: Adyar Cancer Institute, WIA, Chenni, India
name: Department of Public Health and Preventive Medicine (DPH & PM), Chennai, India
First posted: 2025-03-13
Enrollment: 1120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Screening Participation Rate
timeFrame: 1 month after the participation
measure: Invitation coverage in both arms
timeFrame: 6 months
measure: Examination coverage in both arms
timeFrame: 6 months
measure: Further assessment coverage in both arm
timeFrame: 6 months
measure: Detection of cancers in both arms
timeFrame: 6 months
measure: Treatment referral in both arms
timeFrame: 6 months
Secondary outcomes:
measure: Implementation research outcomes - Reach
timeFrame: 6 months
measure: Implementation research outcomes - Effectiveness
timeFrame: 6 months
measure: Implementation research outcomes - Acceptability
timeFrame: 6 months
Other outcomes:
Locations:
city: Chennai
country: India
facility: Adyar cancer institute
state: Tamil Nadu
Study officials:
affiliation: Department of Public Health and Preventive Medicine
name: T.S. Selvavinayagam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Health Mission-Tamil Nadu
name: Jerard Maria Selvam
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Public Health and Preventive Medicine
name: K. Krishnaraj
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Public Health and Preventive Medicine
name: Vidhya Viswanathan
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Institute (WIA), Chennai
name: N.V. Vani, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Institute (WIA), Chennai, India
name: R. Swaminathan, PhD
role: PRINCIPAL_INVESTIGATOR
References: