| CTRI Number |
CTRI/2025/12/099578 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A study on developing a mobile application– "ONCOSMART" to prepare cancer patients for surgery. |
|
Scientific Title of Study
|
Development and validation of an e-health app –ONCOSMART to support prehabilitation in cancer patients. |
| Trial Acronym |
ONCOSMART |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srikanth A |
| Designation |
Under Graduate Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research, Sri Ramachandra Nagar, Porur, Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
9884296898 |
| Fax |
|
| Email |
asrikanth2907@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sridevi S |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research, Sri Ramachandra Nagar, Porur, Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
9841401565 |
| Fax |
|
| Email |
devibsmoorthy@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sridevi S |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research, Sri Ramachandra Nagar, Porur, Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
9841401565 |
| Fax |
|
| Email |
devibsmoorthy@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Srikanth A |
| Address |
Sri Ramachandra Institute of Higher Education and Research, Sri Ramachandra Nagar, Porur, Chennai. |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Srikanth A |
Department Of Medical Oncology, Sri Ramachandra Medical Centre. |
Sri Ramachandra Institute of Higher Education and Research, Sri Ramachandra Nagar, Porur, Chennai,
Chennai
TAMIL NADU |
9884296898
asrikanth2907@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SRU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C768||Malignant neoplasm of other specified ill-defined sites, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Physiotherapy |
Personalized exercises for cancer patients. Frequency: 1 session per day. Duration: 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
Both genders, aged 18 to 64 years, who provide signed informed consent for participation. Cancer patients with a confirmed diagnosis of stage I-III who are scheduled for surgical resection. Patients must own a personal, functioning smartphone and demonstrate basic digital literacy (good handling skills)
|
|
| ExclusionCriteria |
| Details |
Cancer patients with acute hemodynamic instability, uncontrolled severe co-morbidities (e.g., uncontrolled hypertension, severe cardiac arrhythmia). Cancer patients with pre-existing severe musculoskeletal or neurological impairments (e.g., severe arthritis, hemiplegia)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| User Mobile Application Rating Scale (uMARS) score. |
1 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduce the length of hospital stay, Improve Airway Clearance, Improve functional capacity. |
1 Month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
19/01/2026 |
| 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="6"
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
|
This is a Prospective Pilot Study to develop and validate the e-health application- ONCOSMART which supports prehabilitation in cancer patients undergoing surgery. The study will enroll 30 consented cancer patients instructing them to follow the app’s exercises and education. The primary outcome is to validate app’s usability and feasibility, by collecting patient feedback using the User Mobile Application Rating Scale (uMARS).The secondary outcome is to improve functional capacity, reduce hospital stay, and achieve successful prehabilitation before surgical procedures. |