| CTRI Number |
CTRI/2022/12/048282 [Registered on: 20/12/2022] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Design of an electronic system to record patient provided information |
|
Scientific Title of Study
|
Patient Reported Outcomes during Curative Treatment with Radiotherapy assessed using an Online Reporting System: Design and Deployment |
| Trial Acronym |
PROCTOR I |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Santam Chakraborty |
| Designation |
Consultant |
| Affiliation |
Tata Medical Center |
| Address |
14 MAR E-W, Department of Radiation Oncology, Tata Medical Center, Kolkata
North Twentyfour Parganas
WEST BENGAL
700156
India |
| Phone |
03366057402 |
| Fax |
|
| Email |
santam.chakraborty@tmckolkata.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Santam Chakraborty |
| Designation |
Consultant |
| Affiliation |
Tata Medical Center |
| Address |
14 MAR E-W, Department of Radiation Oncology, Tata Medical Center, Kolkata
North Twentyfour Parganas
WEST BENGAL
700156
India |
| Phone |
03366057402 |
| Fax |
|
| Email |
santam.chakraborty@tmckolkata.com |
|
Details of Contact Person
Public Query
|
| Name |
Santam Chakraborty |
| Designation |
Consultant |
| Affiliation |
Tata Medical Center |
| Address |
14 MAR E-W, Department of Radiation Oncology, Tata Medical Center, Kolkata
North Twentyfour Parganas
WEST BENGAL
700156
India |
| Phone |
03366057402 |
| Fax |
|
| Email |
santam.chakraborty@tmckolkata.com |
|
|
Source of Monetary or Material Support
|
| The International Digital Health &
AI Research Collaborative |
|
|
Primary Sponsor
|
| Name |
Tata Medical Center |
| Address |
14 MAR E-W, Tata Medical Center, Kolkata |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Santam Chakraborty |
Tata Medical Center |
14 MAR E-W, Department of Radiation Oncology
North Twentyfour Parganas
WEST BENGAL |
03366047402
santam.chakraborty@tmckolkata.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Medical Center |
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 |
| Comparator Agent |
NA |
NA |
| Intervention |
Use of e-PROM system to evaluate patient reported outcomes. |
User experience testing of the developed e-PROM system amongst patients and healthcare professionals |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed with cancer either undergoing active treatment in the form of radiotherapy or systemic therapy or undergoing follow up
2. Having access to a smartphone or willing to use a tablet computer to answer e-PROM questionnaires.
3. Willing to provide feedback on the usability of the software. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of time the e-PROM system is available during working hours (between Monday to Saturday) during the four month usability testing period |
Proportion of time the e-PROM system is available during working hours (between Monday to Saturday) during the four month usability testing period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Completion rate for submitting the electronic questionnaires by patients |
4 months |
| Average time to complete a questionnaire |
4 months |
| Average time to complete a review |
4 months |
| Average score on the Software Usability Score post test questionnaire |
4 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2023 |
| Date of Study Completion (India) |
29/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
29/03/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not planned as the study did not complete accrual |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patient-reported outcome (PRO) refers to any outcome measure self-reported by the patient. In this study we aim to evaluate a jointly developed electronic patient reported outcome measuring system (e-PROM) in cancer patients. The key objective of the study is to determine the uptime and usability of the system in our patient population. The software is being developed in collaboration with the International Digital health and AI research collaborative and Christian Medical College Vellore. |