| CTRI Number |
CTRI/2025/08/093222 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [P.hD. Thesis , Mindfulness Therapy] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of mindfulness based stress reduction on stress, anxiety, depression, quality of life and self-esteem of post-operative modified radical mastectomy breast cancer patients |
|
Scientific Title of Study
|
Efficacy of mindfulness based stress reduction on stress, anxiety, depression, quality of life and self-esteem of post-operative modified radical mastectomy breast cancer patients: 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 |
Bhavya Rastogi |
| Designation |
P.hD. Scholar & Student Counselor |
| Affiliation |
Geetanjali Medical College and Hospital, Udaipur, Rajasthan |
| Address |
Department of Psychiatry, 1st floor, Geetanjali Medical College and Hospital, Udaipur, Rajasthan
Room no. 223, Clinical Skill training lab, Geetanjali Medical College and Hospital, Udaipur, Rajasthan - 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9999300524 |
| Fax |
|
| Email |
rastogibhavya18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Jitendra Jeenger |
| Designation |
HOD and Profssor, Department of Psychiatry |
| Affiliation |
Geetanjali Medical College and Hospital, Udaipur, Rajasthan |
| Address |
Geetanjali Medical College and Hospital, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9772177234 |
| Fax |
|
| Email |
hodpsychiatry@geetanjaliuniversity.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhavya Rastogi |
| Designation |
P.hD. Scholar & Student Counselor |
| Affiliation |
Geetanjali Medical College and Hospital, Udaipur, Rajasthan |
| Address |
Deoartment of Psychiatry, 1st floor, Geetanjali Medical College and Hospital, Udaipur, Rajasthan
Room no. 223, Clinical Skill training lab, Geetanjali Medical College and Hospital, Udaipur, Rajasthan - 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9999300524 |
| Fax |
|
| Email |
rastogibhavya18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Geetanjali Medical College and Hospital, Udaipur, Rajasthan -313001, India |
|
|
Primary Sponsor
|
| Name |
Geetanjali Medical College and Hospital |
| Address |
Geetanjali Medical College and Hospital, 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 Bhavya Rastogi |
Geetanjali Medical College and Hospital |
Department of Psychiatry, 1st floor, Geetanjali Medical College and Hospital, Udaipur, Rajasthan - 313001
Udaipur
RAJASTHAN |
9999300524
rastogibhavya18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HREC - Human Resource Ethics Comiittee |
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 |
| Comparator Agent |
Standard treatment |
Chemotherapy
Radiotherapy and standard medications |
| Intervention |
Therapeutic intervention |
8 weeks therapeutic intervention of Mindfulness based stress reduction which includes conductions minimum of 2 sessions every week of 30 mins to 40 mins. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. Women Patients in age group 18 – 70 years.
2. Patients willing to participate in the study after giving written informed consent.
3. Patients diagnosed with breast cancer and have undergone the process of modified radical mastectomy and are on the follow up.
4. Patients who have scored “8 & above” in the category of stress, “4 & above” in anxiety and “5 & above” in depression according to the scale DASS – 21, will be involved in the study.
5. Patients with the diagnoses of breast cancer Stage 1 – Stage 3 and undergone MRM
|
|
| ExclusionCriteria |
| Details |
1. Patients with pre–existing psychiatric disorders and substance abuse disorder.
2. Patients who have chronic medical condition and have undergone surgical procedures other than Modified Radical Mastectomy for Breast cancer.
3. Patients with Stage IV breast cancer and metastatic cancer.
4. Women who have undergone Breast Conservation Surgery.
5. Patients who are not stable enough to communicate or participate in MBSR training program.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of mindfulness based stress reduction (MBSR) on stress, anxiety, depression, quality of life and self-esteem of post-operative modified radical mastectomy breast cancer patients. |
4weeks - 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
•Breast cancer patients who undergo
modified radical mastectomy often experience severe psychological distress, including stress, anxiety,
and depression,
which can negatively
impact their quality of life and self-esteem.While medical treatments improve physical recovery, the emotional and
psychological challenges remain under-addressed.
•Mindfulness-Based
Stress Reduction (MBSR) has shown potential in managing these issues by
promoting emotional balance, reducing stress, and improving overall mental
well-being.However, there is limited research
on its effectiveness in Indian breast cancer patients.
•This study is can evaluate whether
MBSR is an effective non-pharmacological intervention to improve the mental
health and quality of life of post-operative breast cancer patients. It could
also provide valuable insights for integrating MBSR into standard
post-operative care. |