| CTRI Number |
CTRI/2024/04/066398 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Mobile application usage] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Mobile application in the management of cancer |
|
Scientific Title of Study
|
Medical Technology based smartphone application in the management of cancer |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hari Prakash |
| Designation |
PhD Scholar |
| Affiliation |
JSS Medical College |
| Address |
2nd floor, Dept of Community Medicine, SS Nagar, Bannimantap, Mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
7306789341 |
| Fax |
|
| Email |
hariprakash607@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hari Prakash |
| Designation |
PhD Scholar |
| Affiliation |
JSS Medical College |
| Address |
2nd floor, Dept of Community Medicine,SS Nagar, Bannimantap, Mysuru
KARNATAKA
570015
India |
| Phone |
7306789341 |
| Fax |
|
| Email |
hariprakash607@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Kumar D |
| Designation |
Professor and Head |
| Affiliation |
JSS Medical College |
| Address |
2nd floor, Dept of Community Medicine, SS Nagar, Bannimantap, Mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
6366366663 |
| Fax |
|
| Email |
sunilkumard@jssuni.edu.in |
|
|
Source of Monetary or Material Support
|
| JSS Medical COllege, JSS Academy of Higher Education and Research, SS Nagar, bannimantap, Mysuru, Karnataka. Pin 570015. |
|
|
Primary Sponsor
|
| Name |
JSS Academy of Higher Education and Research |
| Address |
SS Nagar, mysuru |
| Type of Sponsor |
Private medical college |
|
|
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 Kiran PK |
JSS Medical College |
1st floor, Dept of Medical Oncology, MG Road, Mysuru-570004
Mysore
KARNATAKA |
9900471070
kiranpk@jssuni.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C184||Malignant neoplasm of transverse colon, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Android Mobile application named Onco care |
Intervention group receives access to the smartphone application developed and validated for cancer chemotherapy patients |
| Comparator Agent |
Receive standard cancer care at the hospital |
Tracked for 6 months per standard follow-up protocols and schedules and Receive all other components of care like intervention group other than the app |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
The study includes cancer patients undergoing chemotherapy at JSS Hospital. Only those patients who have informed consent will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients with severe complications and those who do not have access to a smartphone will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Treatment adherence levels among cancer patients undergoing chemotherapy |
Treatment adherence levels among cancer patients undergoing chemotherapy after 6 months of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life scores among cancer patients undergoing chemotherapy |
This will be measured using the EORTC Q-30 questionnaire, which is a validated 30-item tool often used in cancer trials to assess health-related quality of life 6 months of intervention. |
|
|
Target Sample Size
|
Total Sample Size="204"
Sample Size from India="204"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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="0"
Months="6"
Days="2" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Primary Purpose: To develop and validate a smartphone application for improving cancer chemotherapy management, especially in areas of treatment adherence and quality of life.
Hypothesis: Use of a smartphone application tailored for cancer patients will improve medication adherence levels and quality of life scores among cancer chemotherapy patients compared to standard care alone.
Title: Medical Technology-Based Smartphone Application for Cancer Management
Design: 6-month randomized controlled trial with 101 chemotherapy patients
Groups: Intervention (app) vs control (standard care)
Primary Outcomes: Medication adherence (MARS questionnaire); Quality of life (EORTC Q-30)
Analysis: Compare differences between groups on adherence and quality of life using statistical analysis
The application incorporates features like treatment reminders, adverse effect monitoring, education, and patient-provider communication aimed at empowering patients and addressing major gaps in existing cancer care delivery. We hypothesize the smartphone app will significantly improve medication adherence levels and quality of life compared to standard care without use of the app. Findings from this study will provide evidence on the benefits of using mobile health technology to enhance cancer care and self-management. |