FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083083 [Registered on: 21/03/2025] Trial Registered Prospectively
Last Modified On: 18/03/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Implementation 
Study Design  Other 
Public Title of Study   Addressing Delays in Cancer Diagnosis and Treatment through Guided Referral and Follow-up  
Scientific Title of Study   Strengthening Early Detection for Breast, Cervical, and Oral Cancers in Viluppuram District, Tamil Nadu – An Implementation Research Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CTRI/2022/09/045927 (Pre-intervention Protocol)  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R Swaminathan 
Designation  Associate Director 
Affiliation  Cancer Institute (WIA) 
Address  Dr S Krishnamurthi campus, Baghwan Adhinath Jain Complex, Room No: 47, Department of Epidemiology, Biostatistics and Cancer Registry No 38, Sardar patel road, Adyar Chennai

Chennai
TAMIL NADU
600036
India 
Phone  04422209150  
Fax    
Email  r.swaminathan@cancerinstitutewia.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr R Swaminathan 
Designation  Associate Director 
Affiliation  Cancer Institute (WIA) 
Address  Dr S Krishnamurthi campus, Baghwan Adhinath Jain Complex, Room No: 47, Department of Epidemiology, Biostatistics and Cancer Registry No 38, Sardar patel road, Adyar Chennai

Chennai
TAMIL NADU
600036
India 
Phone  04422209150  
Fax    
Email  r.swaminathan@cancerinstitutewia.org  
 
Details of Contact Person
Public Query
 
Name  Dr R Swaminathan 
Designation  Associate Director 
Affiliation  Cancer Institute (WIA) 
Address  Dr S Krishnamurthi campus, Baghwan Adhinath Jain Complex, Room No: 47, Department of Epidemiology, Biostatistics and Cancer Registry No 38, Sardar patel road, Adyar Chennai

Chennai
TAMIL NADU
600036
India 
Phone  04422209150  
Fax    
Email  r.swaminathan@cancerinstitutewia.org  
 
Source of Monetary or Material Support  
Medical Research Council UK 1-3 Burtonhole Lane, London, England, NW7 1AD 
 
Primary Sponsor  
Name  Medical Research Council MRC 
Address  1-3 Burtonhole Lane, London, England, NW7 1AD  
Type of Sponsor  Other [International Funding Agency for Medical Research] 
 
Details of Secondary Sponsor  
Name  Address 
International Agency for Research on Cancer  25 avenue Tony Garnier, CS 90627, 69366 LYON CEDEX 07, France  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr R Swaminathan   Cancer Institute WIA   Dr S Krishnamurthi campus, Baghwan Adhinath Jain Complex, Room No: 47, Department of Epidemiology, Biostatistics and Cancer Registry No 38, Sardar patel road, Adyar Chennai 600 036
Chennai
TAMIL NADU 
04422209150
04424912085
r.swaminathan@cancerinstitutewia.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Directorate of Public Health and Preventive Medicine  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Cancer Care Pathway  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All cancer screen-positive and suspected cancer cases in Viluppuram district, Tamil Nadu. 
 
ExclusionCriteria 
Details  Not applicable 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduced diagnostic and treatment delays for cancer patients.
Improved adherence to appointments and treatment regimens.
Enhanced support and guidance for patients through the cancer care pathway
 
18 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Assess the feasibility and acceptability of the intervention among healthcare workers and patients.
Identify barriers and facilitators to effective implementation of the intervention
Evaluate the costing of the intervention.
Assessment of system readiness and capacity to sustain and scale up the intervention.
 
18 months 
 
Target Sample Size   Total Sample Size="350"
Sample Size from India="350" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 

 
Close