| CTRI Number |
CTRI/2024/05/067890 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the efficacy of a Brief Psychological intervention on reducing stress and improving coping in patient diagnosed with breast cancer for less than one month. |
|
Scientific Title of Study
|
Effectiveness of a brief psychological intervention on stress and coping among newly diagnosed breast cancer patients at AIIMS Delhi a Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhishikha |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
AIIMS, New Delhi. |
| Address |
Porta Cabin-2, College of Nursing, AIIMS New Delhi-110029.
South
DELHI
110029
India |
| Phone |
8287837119 |
| Fax |
|
| Email |
abhishikha1432@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Yumnam Surbala Devi |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi. |
| Address |
Porta Cabin-2, College of Nursing, AIIMS New Delhi-110029.
South
DELHI
110029
India |
| Phone |
9953559853 |
| Fax |
|
| Email |
surshaikhom@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhishikha |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
AIIMS, New Delhi. |
| Address |
Porta Cabin-2, College of Nursing, AIIMS New Delhi-110029.
South
DELHI
110029
India |
| Phone |
8287837119 |
| Fax |
|
| Email |
abhishikha1432@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
AIIMS New Delhi-110029 |
| 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 |
| Dr Atul Batra |
All India Institute of Medical Sciences, New Delhi |
Institute Rotary Cancer Hospital and Surgical Block All India Institue of Medical Sciences New Delhi-110029
South
DELHI |
9013078407
batraatul85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Postgraduate Research All India Institute of Medical Sciences Ansari Nagar, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brief Psychological Intervention |
It is the 4 weekly sessions over one month duration; comprising of psychoeducation and mindfulness based cognitive therapy. Each session is 30-45 minutes of duration. The sessions include one-time
psychoeducation and use of mindfulness based cognitive therapy.
The sessions will be administered face to face or
telephonically based on participants convenience and availability. Patients will be asked to
practice these strategies at home and will be asked to maintain a daily diary. |
| Comparator Agent |
Treatment as usual. |
Participants in control group will undergo usual diagnostic and therapeutic procedures for 4 weeks duration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who have been newly diagnosed with breast cancer (within the previous month), already diagnose by consultant with histopathological examination report.
2.Patients aged 18 years and older;
3.Patients who are able to read English or Hindi.
|
|
| ExclusionCriteria |
| Details |
1.Have a history of pre-existing psychiatric illness;
2.Currently receive any psychotherapy or counselling;
3.Are physically unfit for this study’s interventions (ECOG greater than 2).
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
stress
coping |
3 time points
t0: at the time of enrollment
t1: immediately after completion of intervention
t2: 4 weeks after t1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between stress and coping with socio-demographic variables. |
4 and 8 weeks. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="5"
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
|
This study is a randomized, parallel group, trial assessing the effectiveness of brief psychological intervention on stress and coping among newly diagnosed breast cancer patients taking treatment from AIIMS New Delhi, India. The
primary outcome measures will be stress and coping 4 and
8 weeks. The intervention is 4 sessions, each of 30-45 minutes derived from principle of mindfulness based cognitive therapy. |