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CTRI Number  CTRI/2025/03/081978 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 11/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Testing a Program to Help Women with Breast Cancer Stay Strong and Positive 
Scientific Title of Study   Feasibility and Acceptance of Resilience-Based Intervention in Breast Cancer: A Pilot Study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Annie Alexander 
Designation  Lecturer 
Affiliation  St Johns Research Institute 
Address  Division of Mental Health and Neurosciences, Admini block - Ground floor, Room name - Aadhara, St Johns Research Institute, Sarjapur Road, Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9845219201  
Fax    
Email  annie@sjri.res.in  
 
Details of Contact Person
Scientific Query  
Name  Annie Alexander 
Designation  Lecturer 
Affiliation  St Johns Research Institute 
Address  Division of Mental Health and Neurosciences, Admini block - Ground floor, Room name - Aadhara, St Johns Research Institute, Sarjapur Road, Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9845219201  
Fax    
Email  annie@sjri.res.in  
 
Details of Contact Person
Public Query  
Name  Annie Alexander 
Designation  Lecturer 
Affiliation  St Johns Research Institute 
Address  Division of Mental Health and Neurosciences, Admini block - Ground floor, Room name - Aadhara, St Johns Research Institute, Sarjapur Road, Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9845219201  
Fax    
Email  annie@sjri.res.in  
 
Source of Monetary or Material Support  
Fogarty International Centre and National Institution of Mental Health, USA 
 
Primary Sponsor  
Name  Fogarty International Centre and National Institution of Mental Health, USA 
Address  University of California Health, Global Health Institution, USA 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dinesh MG  Can C Superspeciality Centre  7/64, 59th Cross, Entrance, opp. MEI Polytechnic, 4th block, Rajajinagar, Bengaluru 560010
Bangalore
KARNATAKA 		 9916099360

drdineshmg@gmail.com 
Annie Alexander  St Johns Hospital and Medical College  193, 1, Hosur Rd, Santhosapuram, Koramangala Industrial Layout, Koramangala, Bengaluru, Karnataka 560034
Bangalore
KARNATAKA 		 9845219201

annie@sjri.res.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Can C Superspeciality centre - St Johns Medical College  Approved 
St Johns Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50-C50||Malignant neoplasms of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Resilience Based Intervention (RBI)  There are two parts to the RBI: (1) An educational booklet and (2) The main resilience intervention module. Education Booklet: Initially, all the breast cancer women would be handover an educational booklet providing psychoeducation on breast cancer. The content of the educational booklet is from qualitative data. The concepts address the physical, emotional and social challenges associated with breast cancer treatment. It consisted of the nature of breast cancer, treatment, side effects, and coping methods, with self-care. The self-care addresses seven areas to incorporate into their cancer journey. Those are nutrition, exercise, sleep, humour, communication, expressive writing and religion/spirituality. In this educational booklet, we have included the verbatim of qualitative data from participants to have a resilience approach in their breast cancer journey. The educational booklet would be given at the time of recruitment and used along the way to intervention sessions. The Main Resilience Intervention Module: This module is divided into four sections (prevent, restore, connect and growth) that aim to enhance resilience in women undergoing anti-cancer therapy. Each section contains two to three sessions that focus on developing middle-range concepts and skills from the theoretical framework. The intervention consists of a total of 9 weekly sessions that are 60 minutes long. Each of the session aims for: • Identifying and Managing Distress • Embracing Emotions with Self-compassion • Finding Balance: Mindfulness and Confidence Building • Overcoming with Anchors, Normalcy, and Social Resilience • Discovering Strength: Internal and External Resilience • Spotting Strength: Appreciating and Nurturing Family Resilience • Cultivating Gratitude and Spirituality • Building Positive Habits and Finding Meaning in Suffering • Connecting with Others: Fostering Relationships and Termination 
Comparator Agent  Treatment as Usual (TAU)   The standard cancer treatment provided by the oncologist.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  Women Living with Breast Cancer (WLBC) are diagnosed with stage I, II, or III Breast Cancer (BC).
Currently undergoing BC therapy.
Fluent in English or Kannada. 
 
ExclusionCriteria 
Details  Individuals are unaware of their BC diagnosis.
Those with recurrent BC or previously diagnosed with other cancers.
Critically ill patients admitted to intensive care units.
Individuals with hearing or speech impairments. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Resilience and Adherence to breast cancer treatment   pre-, post-intervention (3rd month) and follow-up (4th month) after the baseline assessment 
 
Secondary Outcome  
Outcome  TimePoints 
Mental health - Distress, Depression, Quality of Life and Posttraumatic growth   pre-, post-intervention (3rd month) and follow-up (4th month) after the baseline assessment 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Phase 2 
Date of First Enrollment (India)   01/10/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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  
This pilot randomized controlled trial aims to evaluate the feasibility, acceptability, and preliminary effectiveness of a Resilience-Based Intervention (RBI) among women living with breast cancer (WLBC) undergoing therapy at St. John’s Medical College Hospital and CAN-C Superspeciality Centre in Bengaluru. Fifty WLBC in the initial phase of breast cancer treatment will be purposively sampled and randomly assigned to either the experimental group (RBI) or waitlist control group (TAU). The RBI program comprises nine sessions focusing on psychoeducation, resilience-building through positive psychology constructs like gratitude and mindfulness, and cognitive-behavioral strategies to address psychological, social, and emotional challenges.
Outcomes will include resilience and adherence to breast cancer treatment, assessed pre-, post-intervention (3 months), and follow-up (4 months) after baseline. Secondary outcomes include mental health indicators such as distress, depression, quality of life, and posttraumatic growth. In-depth interviews with WLBC, family members, and healthcare professionals will explore the acceptability and cultural relevance of the RBI.
 
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