| 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
|
|
|
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 |
|
|
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. |