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临床试验/CTRI/2025/03/082195
CTRI/2025/03/082195尚未招募不适用

Strengthening Early Detection for Breast, Cervical, and Oral Cancers in Viluppuram District, Tamil Nadu – An Implementation Research Study

Medical Research Council (MRC)1 个研究点 分布在 1 个国家目标入组 6,000 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
6,000
试验地点
1
主要终点
Improved community engagement and increased participation in cancer screening programs

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 59.00 Year(s)(—)
性别
All

入选标准

  • All adults aged 20-59 in the chosen intervention/control villages will be included in the study.

排除标准

  • Individuals below 20 and above 60 years of age.
  • Individuals with cognitive impairment.

结局指标

主要结局

Improved community engagement and increased participation in cancer screening programs

时间窗: Intervention period - 12 months | Post-intervention assessment – 6 months

次要结局

  • Assess the feasibility and acceptability of the intervention among healthcare workers and community members.(Identify barriers and facilitators to effective implementation of the intervention)

研究者

发起方
Medical Research Council (MRC)
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr R Swaminathan

Cancer Institute WIA

研究点 (1)

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