| 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
|
|
|
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
|
|
|
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. |