Skip to main content
Clinical Trials/CTRI/2025/03/083083
CTRI/2025/03/083083
Not yet recruiting
Not Applicable

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

Medical Research Council MRC1 site in 1 country350 target enrollmentStarted: April 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Medical Research Council MRC
Enrollment
350
Locations
1
Primary Endpoint
Reduced diagnostic and treatment delays for cancer patients.

Overview

Brief Summary

The Access Cancer Care India (ACCI) project aims to improve early detection and treatment of cancer through evidence-based interventions specifically designed for the local healthcare system. A pre-intervention assessment was conducted in four blocks (Mailam, Vanur, Vikravandi, and Kanai) of the Viluppuram district to identify key barriers to Cancer Care. To develop an effective evidence-based strategy, surveys, focus group discussions, and in-depth interviews were conducted with key stakeholders. Significant patient-side and system-level delays were identified in the cancer care pathway, leading to the late reporting of screen-positive and symptomatic individuals to referral centers for further management. While the district has formed a comprehensive cancer care committee to audit and address these system-based delays, there exists a need for a dedicated, continuous navigation system to manage patient and system delays in the cancer care pathway.

This study evaluates the effectiveness of implementing a comprehensive patient navigation system to facilitate timely access to diagnosis and treatment for suspected cancer cases. The navigation system will be integrated within the public health infrastructure in Viluppuram District and will target individuals identified as screen-positive or symptomatic by the cancer screening services. Two dedicated patient navigators will assist these individuals, along with healthcare staff seeking navigation services, performing the following responsibilities:

  • Monitoring the list of screen-positive individuals through the organized cancer screening (OCS) line list/Google Sheet.

  • Contact individuals by telephone or in-person to guide them through further evaluation and treatment.

  • Assisting in appointment scheduling and coordinating visits to referral centers for diagnosis and treatment with healthcare providers.

  • Obtaining and communicating screening and diagnostic results to patients.

  • Helping confirmed cancer patients access free public transport cards and Social Security schemes.

  • Establishing and managing cancer helpline numbers to provide information, clarify doubts, and guide patients regarding available cancer care services and testing instructions.

This study will adopt a mixed-methods approach guided by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) and will be monitored for fidelity. A process evaluation will document implementation challenges and necessary adaptations. By enhancing access to timely diagnosis and treatment, this intervention aims to improve cancer survival rates, promote early detection, and enhance the quality of life for patients in rural Tamil Nadu. Additionally, a cost-effectiveness analysis will assess the feasibility of scaling up this model, while the study will also explore strategies for integrating patient navigators into the existing healthcare system to ensure long-term sustainability.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
25.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • All cancer screen-positive and suspected cancer cases in Viluppuram district, Tamil Nadu.

Exclusion Criteria

  • Not applicable.

Outcomes

Primary Outcomes

Reduced diagnostic and treatment delays for cancer patients.

Time Frame: 18 months

Improved adherence to appointments and treatment regimens.

Time Frame: 18 months

Enhanced support and guidance for patients through the cancer care pathway

Time Frame: 18 months

Secondary Outcomes

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

Investigators

Sponsor
Medical Research Council MRC
Sponsor Class
Other [International Funding Agency for Medical Research]
Responsible Party
Principal Investigator
Principal Investigator

Dr R Swaminathan

Cancer Institute (WIA)

Study Sites (1)

Loading locations...

Similar Trials