| CTRI Number |
CTRI/2026/04/108942 [Registered on: 21/04/2026] Trial Registered Prospectively |
| Last Modified On: |
17/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Mobile App based intervention on Metabolic Syndrome and Treatment Adherence] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of a Mobile Phone App to Improve Metabolic Health and Treatment Adherence in Adult Cancer Patients |
|
Scientific Title of Study
|
A Randomized Controlled Trial to evaluate the Effectiveness of Mobile App (CANMET)Based Interventions on Metabolic Syndrome and Treatment Adherence among Adult Oncology Patients Receiving Systemic Anticancer Treatment in IRCH, AIIMS New Delhi. |
| Trial Acronym |
MS APP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jeena John |
| Designation |
M.Sc (Nursing) (oncology Nursing) |
| Affiliation |
AIIMS, New Delhi |
| Address |
College of Nursing, Porta Cabin, Near Old OT Block, AIIMS, New Delhi.
New Delhi DELHI 110029 India |
| Phone |
9643355584 |
| Fax |
|
| Email |
lizjohnrose@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Latha Venkatesan |
| Designation |
Professor cum Principal |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No.1, Ground floor, College of Nursing, Near Old OT block, AIIMS, New Delhi.
New Delhi DELHI 110029 India |
| Phone |
9310502069 |
| Fax |
|
| Email |
latha6901@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Latha Venkatesan |
| Designation |
Professor cum Principal |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No.1, Ground floor, College of Nursing, Near Old OT block, AIIMS, New Delhi.
New Delhi DELHI 110029 India |
| Phone |
9310502069 |
| Fax |
|
| Email |
latha6901@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jeena John |
| Address |
Porta Cabin, College of Nursing Near Old OT Block, AIIMS, New Delhi. India 110074 |
| Type of Sponsor |
Other [Academic purpose] |
|
|
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 |
| DrLatha Venkatesan |
AIIMS, New Delhi |
MRO Ward, Daycare, MO Ward
Dr B.R.A. IRCH, AIIMS, New Delhi
110074 South DELHI |
9310502069
latha6901@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POSTGRADUATE RESEARCH,ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI 110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, (2) ICD-10 Condition: E70-E88||Metabolic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CANMET mobile app based intervention |
The interventions will be delivered via the CANMET Mobile App, a digital health platform designed to support for MetS management and treatment adherence on the following components
• Lifestyle modification
• Dietary counselling
• Physical activity guidance
• Sleep hygiene
• Stress management
• Pharmacological support and monitoring schedule
Participants of the mobile application group will get a description about the features of the app and how to install and use it. The intervention and follow-up period will be 3 months.
|
| Comparator Agent |
Standard care |
Standard nursing care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult aged more than 18 years with a confirmed diagnosis of Ca Breast, Ca colon, GCT, Lymphoma, ca ovary
2. Currently receiving /initiated active adjuvant chemotherapy within the past 1 month
3. Individuals who meet the NCEP ATP III criteria
4. Individuals who have access to a smart phone
|
|
| ExclusionCriteria |
| Details |
1.Patient’s receiving palliative chemotherapy or having confirmed metastatic disease.
2.participating in another medical research or lifestyle intervention that may interfere with outcome.
3.Patients with cognitive or sensory impairments
4.Patients who are unable to read or understand the app content
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Metabolic Syndrome components, Treatment Adherence |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| feasibility and acceptability of CANMET App |
6 weeks |
| association between sociodemographic variables, and metabolic syndrome components, treatment adherence, in the experimental group before and after receiving CANMET mobile app- based interventions |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
01/08/2026 |
| 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="3" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [lizjohnrose@gmail.com].
- For how long will this data be available start date provided 30-11-2027 and end date provided 19-07-2032?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This study is conducted for early identification of metabolic disorders in cancer patients who are in the initial period of chemotherapy, as metabolic syndrome will interfere with their prognosis and survival. If metabolic syndromes are identified during their initial treatment period of chemotherapy, with proper interventions and adequate treatment adherence measures, we can improve their long-term health and quality of life of cancer survivors. There are so many studies on cancer survivors, but very few studies on the active treatment period of chemotherapy and metabolic syndrome interventions. The CANMET App is a mobile app-based intervention on metabolic syndrome and treatment adherence , which helps the adult oncology patients to an improved, sustained period of survivorship. An RCT is the most rigorous method to determine if the CANMET APP is truly effective over standard care, justifying its widespread adoption and integration into the national care protocol. |