| CTRI Number |
CTRI/2025/02/080742 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Pilot Study on Deploying Oncology-Specific Telemedicine (TeleOPD) Platform in the North-Eastern States of India |
|
Scientific Title of Study
|
Deploying Oncology Specific Telemedicine (TeleOPD) platform in the North- Eastern states of India a
pilot study
|
| Trial Acronym |
TeleOPD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manju Sengar |
| Designation |
Head and Professor- Medical Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
National Cancer Grid,
10th Floor, Homi Bhabha Block,
Tata Memorial Hospital
Mumbai-400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9769690590 |
| Fax |
|
| Email |
manju.sengar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju Sengar |
| Designation |
Head and Professor- Medical Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
National Cancer Grid,
10th Floor, Homi Bhabha Block,
Tata Memorial Hospital
Mumbai-400012
MAHARASHTRA
400012
India |
| Phone |
9769690590 |
| Fax |
|
| Email |
manju.sengar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manju Sengar |
| Designation |
Head and Professor- Medical Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
National Cancer Grid,
10th Floor, Homi Bhabha Block,
Tata Memorial Hospital
Mumbai-400012
MAHARASHTRA
400012
India |
| Phone |
9769690590 |
| Fax |
|
| Email |
manju.sengar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Corporate Social Responsibility Funding through Axis bank
The funding will be facilitated by TMH Institute. Address: Funding Cell Office, 13th Floor, Homi Bhabha Building, Tata Memorial Hospital, Parel, Mumbai Pin code 400012
|
| Main Building Ground Floor, Director TMH Office, Tata Memorial Hospital, Parel, Mumbai Pin code 400012 |
|
|
Primary Sponsor
|
| Name |
National Cancer Grid |
| Address |
National Cancer Grid,
10th Floor, Homi Bhabha Block,
Tata Memorial Hospital
Mumbai-400012, Maharashtra, India. |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manju Sengar |
Tata Memorial Hospital |
Homi Bhabha Block,
National Cancer Grid Office, 10th Floor,
Department
Department of Medical Oncology
Dr E Borges Road,
Parel, Mumbai,
Maharashtra 400012, India.
Mumbai
MAHARASHTRA |
9769690590
manju.sengar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 years and above.
2. Patients who are willing to provide informed consent for participation in the study.
3. Patients who are able to communicate in the local language (Manipuri), Hindi/English.
4. Patients who are clinically stable and do not require emergency care.
5. Follow-up patients who have been treated at Tata Memorial Hospital (TMH) and are in remission at the last physical follow-up.
6. Patients who have completed treatment and are now on follow-up but have symptoms requiring
examination.
7. New patients
8. Patients seeking a second opinion |
|
| ExclusionCriteria |
| Details |
1.Patients who are unable to communicate effectively in the local language/Hindi/English.
2.Patients with cognitive impairments that prevent them from understanding and following telemedicine instructions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To establish telemedicine consultations for cancer care in rural and remote areas of North East India, utilizing NCG experts.
2.To develop and implement a training program for local healthcare providers on NCG guidelines and the use of the telemedicine platform.
3.To facilitate seamless coordination between primary care providers, local hospitals (spokes), and specialized center–Tata Memorial Hospital (the hub) for ongoing patient management and follow-up care of patients with cancer |
Time point for first objective: 2 months
Time point for second objective: 1 month
Timepoint for third objective: 08 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
26/02/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Objective:This pilot study aims to establish a telemedicine platform for cancer care in rural and remote areas of Northeast India, leveraging NCG experts and 10BedICU facilities. The goal is to improve access to specialized oncology consultations, reduce travel burdens, and streamline patient follow-ups. Methodology:- Study Design: Prospective observational pilot study using a hub-and-spoke model.
- Hub: Tata Memorial Hospital (TMH), Mumbai
- Spokes: District hospitals in Churachandpur, Ukhrul, and Thoubal (Manipur)
- Study Duration: 12 months
- First 2 months: Recruitment & training of local healthcare providers
- Month 3: Pilot run with dummy patients
- Next 8 months: Live teleconsultations with real patients (~50 patients)
- Final month: Data analysis & oncologist interviews
- Participants: Adult cancer patients (new, follow-up, or seeking a second opinion).
- Key Metrics:
- Average consultation time
- Provider & patient satisfaction scores
- Teleconsultation failure rates
Expected Impact:- Improved cancer care accessibility in underserved regions
- Reduced travel and financial burdens for patients
- Enhanced coordination between primary care providers and oncology experts
- Potential scalability to other National Cancer Grid (NCG) centers if successful
|