| CTRI Number |
CTRI/2023/04/051910 [Registered on: 24/04/2023] Trial Registered Prospectively |
| Last Modified On: |
27/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Mindfulness for cancer patients stress and coping |
|
Scientific Title of Study
|
Effects of a Mindfulness based intervention on stress, coping and quality of life in Indian cancer patients in a palliative care setting: A Prospective Randomized 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 |
Anirban Pal |
| Designation |
Consultant |
| Affiliation |
Apollo Medical Center |
| Address |
Department of Anaesthesia
3rd floor,
48/1F, Leela Roy Sarani, Gariahat
Kolkata
WEST BENGAL
700019
India |
| Phone |
9830761649 |
| Fax |
|
| Email |
pal.anirban1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anirban Pal |
| Designation |
Consultant |
| Affiliation |
Apollo Medical Center |
| Address |
Department of Anaesthesia.
3rd floor
48/1F, Leela Roy Sarani, Gariahat
Kolkata
WEST BENGAL
700019
India |
| Phone |
9830761649 |
| Fax |
|
| Email |
pal.anirban1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anirban Pal |
| Designation |
Consultant |
| Affiliation |
Apollo Medical Center |
| Address |
Department of Anaesthesia,
3rd floor,
48/1F, Leela Roy Sarani, Gariahat
Kolkata
WEST BENGAL
700019
India |
| Phone |
9830761649 |
| Fax |
|
| Email |
pal.anirban1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Anirban Pal |
| Address |
43/6/5 Jheel road
Kolkata 700031 |
| Type of Sponsor |
Other [Individual] |
|
|
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 |
| Anirban Pal |
Kalyani ESI Hospital |
Department of public health
A Block, Kalyani,
Pin 741235
Nadia
WEST BENGAL |
9830761649
pal.anirban1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kalyani ESI Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C801||Malignant (primary) neoplasm, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mindfulness based intervention |
A 4 week program to teach Mindfulness. Total duration 4 weeks |
| Comparator Agent |
Usual care program |
A 4 week program to teach usual care. Total duration 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Suffering from cancer |
|
| ExclusionCriteria |
| Details |
End stage disease |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perceived Stress score (PSS 10) will be assessed |
Baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Coping with cancer (21 item questionnaire) and Quality of Life (SF36) |
At baseline and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/05/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
60 patients suffering from cancer will be randomized into 2 groups to undergo ’Mindfulness’ sessions or ’usual care’ sessions. Their perceived stress score, cancer coping score, and quality of life score will be note pre and post program. The program will run for 4 weeks. The data will be analyzed statistically to detect any difference in the scores. |