| CTRI Number |
CTRI/2021/11/037871 [Registered on: 08/11/2021] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Yoga in advanced adult cancer patients in a Respite Palliative Care setting in India |
|
Scientific Title of Study
|
Assessment of feasibility and effectiveness of yoga therapy in psychological distress, quality of life and spirituality in adult advanced cancer patients in a Respite Palliative Care setting in India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayita Deodhar |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Palliative Medicine, Room no 75, Main building, Dr. E. Borges Road, Mumbai
Department of Palliative Medicine, Room no 75, Main building, Dr. E. Borges Road, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
jukd2000@yahoo.co.uk |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayita Deodhar |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Palliative Medicine, Room no 75, Main building, Dr. E. Borges Road, Mumbai
Department of Palliative Medicine, Room no 75, Main building, Dr. E. Borges Road, Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
jukd2000@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayita Deodhar |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Palliative Medicine, Room no 75, Main building, Dr. E. Borges Road, Mumbai
Department of Palliative Medicine, Room no 75, Main building, Dr. E. Borges Road, Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
jukd2000@yahoo.co.uk |
|
|
Source of Monetary or Material Support
|
| Department of Palliative Medicine , Tata Memorial Hospital |
| Respite Palliative Care under Department of Palliative Medicines |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr. E. Borges Road, Mumbai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrJayita Deodhar |
Respite Palliative Care Unit, Dr. Ernest Borges Memorial Home |
Dr.Ernest Borges Memorial Home, Kalanagar, Bandra East, Mumbai 400051
Mumbai
MAHARASHTRA |
7045390210
jukd2000@yahoo.co.uk |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Tata Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Age 18 and above
2 ECOG 0-3
3 Patient admitted at Respite care facility for minimum of 7 days
4 Having ability to comprehend English / Hindi / Marathi
5 Able to provide written informed consent
|
|
| ExclusionCriteria |
| Details |
1 Any evaluable Cognitive impairment
2 Already practicing any form of yoga on regular basis
3 Unable to perform/ adhere yoga intervention
4 Any deterioration in physical condition
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of adult advanced cancer patients able to attend yoga sessions for 7 days |
Number of adult advanced cancer patients able to attend yoga sessions for 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in presence of depression and anxiety from baseline to 7 days as measured by PHQ-9 and GAD-7
Change in symptom burden from baseline to 7 days in patients, as measured by ESAS
Change in spiritual well-being from baseline to 7 days in patients by FACIT SP
Change in quality of life from baseline to one month in patients by EORTCQLQ PALC15
|
Change in presence of depression and anxiety from baseline to 7 days as measured by PHQ-9 and GAD-7
Change in symptom burden from baseline to 7 days in patients, as measured by ESAS
Change in spiritual well-being from baseline to 7 days in patients by FACIT SP
Change in quality of life from baseline to one month in patients by EORTCQLQ PALC15
|
| Compliance after discharge |
We will check for compliance at 15 days and one month. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/11/2021 |
| Date of Study Completion (India) |
20/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study aims to evaluate the feasibility and effectiveness of yoga interventions in reducing symptoms, change in anxiety, depression, change in spiritual wellbeing.
There is a need to create mindfulness in the population as well as healthcare professionals about the benefits of yoga in symptom management and dealing with psychological and spiritual needs; this study aims to address this. |