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CTRI Number  CTRI/2026/03/105758 [Registered on: 10/03/2026] Trial Registered Prospectively
Last Modified On: 09/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding the Feelings and Life Experiences of Cancer Patients Who Carry an Inherited Cancer Risk Gene 
Scientific Title of Study   Exploring the Psychosocial Experience of Cancer Patient Who Tested Positive for BRCA 1/2 germline mutation 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jisha Abraham  
Designation  Lecturer, Division of Psycho-oncology 
Affiliation  Malabar Cancer Center 
Address  Department under the Director Division of Psycho-Oncology Room No.171 Malabar Cancer Centre Thalassery

Kannur
KERALA
670103
India 
Phone  8891944401  
Fax    
Email  jishasarah@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anjali p 
Designation  Fellow Oncology Social Work, Division of Psycho-oncology 
Affiliation  Malabar Cancer Center 
Address  Department under the Director Division of Psycho-Oncology Room No.171 Malabar Cancer Centre Thalassery

Kannur
KERALA
670103
India 
Phone  9497665921  
Fax    
Email  anjalipanand27@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jisha Abraham  
Designation  Lecturer, Division of Psycho-oncology 
Affiliation  Malabar Cancer Center 
Address  Department under the Director Division of Psycho-Oncology Room No.171 Malabar Cancer Centre Thalassery

Kannur
KERALA
670103
India 
Phone  8891944401  
Fax    
Email  jishasarah@gmail.com  
 
Source of Monetary or Material Support  
Malabar Cancer Centre (PGIOSR) Kodiyeri, Muzhikkara, MCC Rd, Illathaazha, Thalassery, Kerala 670103 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
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 
JISHA ABRAHA  Malabar cancer center  Kodiyeri, Muzhikkara - MCC Rd, Illathaazha, Thalassery, Kerala 670103
Kannur
KERALA 
8891944401

jishasarah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Malabar Cancer Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  Cancer patients above the age of 18 years, in spite of their treatment, who received a tested positive BRCA1 or BRCA2 mutation result
Individuals who have received post-test counselling after a positive BRCA1/2 result.
Individuals whose post-test counselling occurred within the time frame of 2 weeks to 1 year.
 
 
ExclusionCriteria 
Details  Patient with a history of any Psychiatric or Psychological condition and any intellectual disability
Patient referred for Best Supportive care
Patient who are having any neurological condition
Patient under are currently on substance use or currently experiencing any withdrawal symptoms
Patients with no primary education
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Understanding the Feelings and Life Experiences of Cancer Patients Who Carry an Inherited Cancer-Risk Gene  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   31/03/2026 
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="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Hereditary mutations in BRCA1 and BRCA2 genes significantly increase the lifetime risk of breast and ovarian cancers. Genetic testing enables early identification of mutation carriers and facilitates personalized surveillance, prophylactic interventions, and informed treatment planning. While the medical benefits of BRCA testing are well established, evidence indicates that receiving a positive BRCA1/2 germline mutation result is associated with considerable psychological distress, including anxiety, uncertainty, fear of recurrence, altered self-identity, and family-related concerns. International studies report heightened anxiety and depressive symptoms particularly in the immediate post-disclosure period; however, there is limited evidence exploring these experiences within the Indian socio-cultural context.

In India, breast cancer incidence is rising, and emerging data suggest a comparatively higher prevalence of BRCA mutations among Indian breast cancer patients. Cultural expectations, family structures, stigma, reproductive concerns, and limited awareness of genetic risk may uniquely influence psychosocial responses following disclosure of a positive mutation status. Despite this, qualitative research exploring the lived psycho-social experiences of Indian cancer patients with BRCA1/2 germline mutations remains scarce.

This study aims to explore the psycho-social experiences of adult cancer patients who have tested positive for BRCA1/2 germline mutations at the Genetics Clinic of Malabar Cancer Centre (PGIOSR), Kerala. Using a qualitative cross-sectional design grounded in Interpretative Phenomenological Analysis (IPA), in-depth semi-structured interviews will be conducted among purposively selected participants who received post-test counselling within the past 2 weeks to 1 year. Data will be collected until saturation and analyzed using thematic analysis with measures to ensure intercoder reliability.

The study seeks to understand immediate, current, and anticipated future psycho-social experiences, including emotional responses, family dynamics, decision-making regarding prophylactic treatment, and perceived support needs. Findings are expected to inform culturally sensitive genetic counselling practices, psychosocial interventions, and supportive care models tailored to the Indian context.

 
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