| CTRI Number |
CTRI/2017/08/009336 [Registered on: 10/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
14/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Yoga on Health related quality of life amongst the patients undergoing chemotherapy for treatment of Lymphoma |
|
Scientific Title of Study
|
Effect of Yoga on Health related quality of life amongst the patients undergoing multi agent chemotherapy for treatment of Aggressive Malignant Lymphoma-A Randomised Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gurpreet Kaur |
| Designation |
Phd scholar |
| Affiliation |
PGIMER |
| Address |
National Institute of Nursing Education
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914222905 |
| Fax |
9914222905 |
| Email |
gurpreetkaurpgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gurpreet Kaur |
| Designation |
Phd scholar |
| Affiliation |
PGIMER |
| Address |
National Institute of Nursing Education
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914222905 |
| Fax |
9914222905 |
| Email |
gurpreetkaurpgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gurpreet Kaur |
| Designation |
Phd scholar |
| Affiliation |
Post graduate institute of medical education and research, Chandigarh |
| Address |
National Institute of Nursing Education
Post Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914222905 |
| Fax |
9914222905 |
| Email |
gurpreetkaurpgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gurpreet Kaur
Phd student
National institute of nursing education
PGIMER,Chandigarh |
|
|
Primary Sponsor
|
| Name |
Gurpreet Kaur |
| Address |
National institute of nursing education, Post graduate institute of medical education and research, Chandigarh |
| Type of Sponsor |
Other [Gurpreet Kaur] |
|
|
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 |
| Gurpreet Kaur |
PGIMER |
Internal medicine OPD, 3RD FLOOR.New OPD
Chandigarh
CHANDIGARH |
9914222905
gurpreetkaurpgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,PGIMER,Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D898||Other specified disorders involving the immune mechanism, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
This group will receive Routine care only |
| Intervention |
Yoga group |
This group will receive both yoga intervention and routine care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with aggressive malignant Lymphoma Stage II-IV, planned to receive chemotherapy between the age of 18-65yrs with ECOG performance score of 0-2
2. Patients willing to participate in the study, and should have access to audio-video displaying device (CD player, multimedia phone /smart phone/laptop)
3. Patients who will be able to understand English, Hindi, Punjabi
|
|
| ExclusionCriteria |
| Details |
1. Patients with stage I Lymphoma
2. Patients who continued to have ECOG score
3-4 even at 2nd chemotherapy cycle
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| FACT Health related quality scores |
Before start of chemotherapy, at 2nd, 4th and 6th month of chemotherapy
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Morbidity profile: Fatigue, sleep quality, depression, anxiety and pain
Adherence |
before start of chemotherapy, 2nd, 4th and 6th month of chemotehrapy |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/03/2017 |
| Date of Study Completion (India) |
14/11/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
pilot study published in IYOY |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomised controlled trail to assess the effectiveness of yoga intervention in patients suffering from malignant Lymphoma undergoing multi agent chemotherapy. Intervention group will be administered Yoga protocol along with routine care, the control group will receive only routine care. The primary outcome variable will be health related quality of life, and secondary outcomes will be fatigue, depression , anxiety, sleep quality and pain. These outcome variables will be assessed at the baseline i.e before start of chemotherapy, at 2nd, 4th and 6th month of chemotherapy. |