| CTRI Number |
CTRI/2025/10/096108 [Registered on: 15/10/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of a 12 week tele rehabilitation intervention to enhance quality of life in cancer patients. |
|
Scientific Title of Study
|
Feasibility Of A Tele Rehabilitation Program To Improve Quality Of Life In Oncology Patients A Prospective Study Using The FACT G Scale. |
| 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 Preksha Jain |
| Designation |
PG Research Scholar |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Hospital building ground floor Physiotherapy Department block 5 Bhilon ka Bedla NH 27 Pratap Pura Girwa
Udaipur RAJASTHAN 313001 India |
| Phone |
9773473219 |
| Fax |
|
| Email |
prekshajain105@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jafar Khan |
| Designation |
Dean and HOD of Physiotherapy Department |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Hospital building ground floor Physiotherapy Department block 5 Bhilon ka Bedla NH 27 Pratap Pura Girwa
Udaipur RAJASTHAN 313001 India |
| Phone |
9214432142 |
| Fax |
|
| Email |
zafarkhan1984@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Manoj U Mahajan |
| Designation |
Professor in Medicine and Director of Oncology Services |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Hospital Building 1st floor Medicine Department block 8 Bhilon ka Bedla NH 27 Pratap Pura Girwa
Udaipur RAJASTHAN 313001 India |
| Phone |
9818051316 |
| Fax |
|
| Email |
drmanoj.mahajan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pacific Medical College and Hospital Bhilon ka Bedla NH 27 Pratap Pura Girwa Udaipur Rajasthan 313001 India |
|
|
Primary Sponsor
|
| Name |
Pacific Medical College and Hospital |
| Address |
Bhilon ka Bedla NH 27 Pratap Pura Girwa Udaipur Rajasthan 313001 |
| 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 Preksha Jain |
Pacific Medical College and Hospital |
Hospital building ground floor Physiotherapy department block 5 Bhilon ka Bedla N H 27 Pratap Pura Girwa 313001 Udaipur RAJASTHAN |
9773473219
prekshajain105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee of PMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C800||Disseminated malignant neoplasm, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Not Applicable as it is a single group pilot feasibility study |
| Intervention |
Physiotherapeutic Tele- Rehabilitation Program |
A 12 weeks structured physiotherapeutic tele- rehabilitation program including Warm-up, aerobic training (walking/arm ergometer), resistance training using body weight/elastic bands, breathing exercises, relaxation, and
stretching exercises conducted via video calls under supervision of Physiotherapist. Intensity maintained at RPE 11-13 or MET 4-6 mLO2/kg/min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adults greater than or equal to 18 years with histologically confirmed carcinoma, ongoing active treatment, post primary treatment or on stable maintenance with Eastern Cooperative Oncology Group Performance status scale 0-2
Medically cleared for low to moderate intensity exercise
Access to smart phone or tablet with video capability and internet
Able to read and respond to study questionnaire |
|
| ExclusionCriteria |
| Details |
Unstable cardiopulmonary disease, uncontrolled pain, or other contraindications to
exercise, terminally ill.
Cognitive/psychiatric conditions precluding participation.
Concurrent enrollment in structured supervised rehabilitation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Determine feasibility and acceptability of 12 weeks structured home based tele rehabilitation program in adult oncology patients, retention at 12 weeks, adherence and safety
|
12 weeks after enrollment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Estimate change in FACT-G total and subscale scores from baseline to 12 weeks
Explore changes in fatigue and physical activity, where applicable |
12 weeks after enrollment |
|
Target Sample Size
Modification(s)
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/11/2025 |
| Date of Study Completion (India) |
06/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="9" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This prospective study aims to assess the feasibility and effectiveness of a structured 12 week tele rehabilitation program in improving the quality of life of oncology patients. Participants will undergo individualized physiotherapy sessions delivered remotely through scheduled video consultations and telephonic follow ups under the supervision of a physiotherapist. The intervention will focus on personalized physical activity and functional exercise programs addressing flexibility strength and endurance along with education on fatigue and symptom management. Eligible participants will be recruited using convenience sampling. Baseline assessment will be performed prior to the intervention followed by reassessments at the end of every month using the Functional Assessment of Cancer Therapy General FACT G scale. Data will be analysed to determine feasibility based on recruitment adherence and retention rates and to evaluate changes in quality of life scores over time. The primary objectives include assessing practicality and acceptability along with retention at 12 weeks and adherence to the treatment and safety while secondary objective includes estimating changes in the scale total and subscale scores in clinical oncology care especially in resource limited settings. The study is expected to provide evidence supporting the integration of tele rehabilitation into standard cancer rehabilitation practices and contribute to the design of larger clinical trials. |