FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/07/055461 [Registered on: 21/07/2023] Trial Registered Prospectively
Last Modified On: 14/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   what is the role of mindfulness in breast cancer survivors. 
Scientific Title of Study   Role of mindfulness based intervention on behavioral and inflammatory parameters in breast cancer survivors in Eastern India: 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  Chandni Sinha 
Designation  Additional Professor 
Affiliation  AIIMS Patna 
Address  Department of Anaesthesia Room No 502 OT Complex AIIMS, Patna

Patna
BIHAR
801505
India 
Phone    
Fax    
Email  chandni.doc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Chandni Sinha 
Designation  Additional Professor 
Affiliation  AIIMS Patna 
Address  Department of Anaesthesia Room 502 OT Complex AIIMS, Patna

Patna
BIHAR
801505
India 
Phone    
Fax    
Email  chandni.doc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Chandni Sinha 
Designation  Additional Professor 
Affiliation  AIIMS,Patna 
Address  Department of Anaesthesia OT complex Room no 502 AIIMS, Patna

Patna
BIHAR
801505
India 
Phone    
Fax    
Email  chandni.doc@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, New Delhi 
 
Primary Sponsor  
Name  ICMR 
Address  Ansari Nagar, New Delhi - 110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Chandni Sinha  AIIMS,Patna  Department of Anaesthesia, Preoperative area, OT complex, 5th Floor IPD Complex
Patna
BIHAR 		 7250333148

chandni.doc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethical Committee, AIIMS,Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  mindfulness based intervention(MBI)  offline supervised session: once a week for 6 weeks online supervised session: once a month for 3 months 
Comparator Agent  waitlist  No intervention till 3 months. The patients might be given a choice to do to MBI after 3 months 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  Breast cancer survivors stage 0 to IIIa who would have completed cancer
treatment within the past 3 years (except for tamoxifen/aromatase inhibitors).
They should be at least 2 months postsurgery or adjuvant therapy or radiation,
whichever occurred later. 
 
ExclusionCriteria 
Details  –Exclusion criteria would be patients on active therapy, inflammatory breast
cancer, anemia, diabetes, chronic obstructive pulmonary disease, uncontrolled
hypertension, evidence of liver or kidney failure, symptomatic ischemic heart
disease, conditions involving the immune system such as autoimmune and/or
inflammatory diseases, cognitive impairment, alcohol/drug abuse, current yoga
practice (within the last 6 months), and/or previous yoga practice for more than
3 months. Women reporting 5 hours or more of vigorous physical activity per
week will also be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
perceived stress and depression: PPS (Perceived Stress Scale) and
HADS 		 baseline, 6 weeks, 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Effect on inflammatory markers: IL-6, interleukin-1 beta , C reactive protein and human TNF
Effect on serum cortisol levels.1 		 baseline, 6 weeks, 3 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   05/08/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Breast cancer is one of the most common cancer in our country. The survivors often suffer from pain, fatigue, stress, anxiety, inability to cope up with the disease etc. There is paucity of literature regarding benefits of mindfulness based intervention: MBI  in this subgroup. MBI is an evidence based intervention with established role in various chronic diseases like diabetes, polyneuropathies, chronic pain conditions etc. It emphasises participants to pay attention to the situation in a compassionate and non judgemental manner. Though there have been studies on breast cancer survivors in Western world, data is lacking in India. hence, this study aims to determine to feasibility and benefits of MBI on psychological, behavioural and biochemical parameters of breast cancer survivors. 
Close