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CTRI Number  CTRI/2023/10/058932 [Registered on: 20/10/2023] Trial Registered Prospectively
Last Modified On: 23/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Memory, Cognitive Functions and Distress among Breast Cancer Patients. 
Scientific Title of Study   Memory, Cognitive Functions and Pattern of Distress among Breast Cancer Patients and Survivors: A Cross-sectional Study. 
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, Psycho-oncology 
Affiliation  Malabar Cancer Centre 
Address  Malabar Cancer Centre, Thalassery, Kannur Kerala.

Kannur
KERALA
670103
India 
Phone  8086767706  
Fax    
Email  jishasarah@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jisha Abraham 
Designation  Lecturer, Psycho-oncology 
Affiliation  Malabar Cancer Centre 
Address  Malabar Cancer Centre, Thalassery, Kannur Kerala.

Kannur
KERALA
670103
India 
Phone  8086767706  
Fax    
Email  jishasarah@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Neeha Jose 
Designation  Fellow in Psycho-oncology 
Affiliation  Malabar Cancer Centre 
Address  Malabar Cancer Centre, Thalassery, Kannur Kerala.

Kannur
KERALA
670103
India 
Phone  944764282  
Fax    
Email  neehajose97@gmail.com  
 
Source of Monetary or Material Support  
Malabar Cancer Centre Thalassery, Kannur, Kerala 
 
Primary Sponsor  
Name  Malabar Cancer Centre 
Address  Malabar Cancer Centre, Thalassery, Kannur Kerala 
Type of Sponsor  Research institution and hospital 
 
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 Abraham  Malabar Cancer Centre  OP No: 21 and 22 Division of Psycho-oncology
Kannur
KERALA 
04902399268

jishasarah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The 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: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. Women diagnosed with Breast Cancer (Stage I/II/III) and planned for or underwent curative intent chemotherapy.
2. Individuals who can read, write and understand english or malayalam.
3. Individuals with a responsible bystander.  
 
ExclusionCriteria 
Details  1. Patients with any known psychiatric or psychological conditions.
2. Patients with a known history of sensory impairment or physical disabilities.
3. Patients having Intellectual Disability.
4. Patients undergoing Palliative intent treatment.
5. Patients with a known history of long term substance use (5 years or more) and individuals who are currently on substance use or having withdrawal.
6. Individuals found to have relapse/recurrence/second primary during Follow-up.
7. Patients with a known history of epilepsy or other brain related impairments, underwent major cardiovascular surgeries, neurological conditions, dementia etc., 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Memory, Cognitive functions and distress among cancer patients  1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Memory, Cognitive functions and distress among cancer patients  1 year 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="79" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/10/2023 
Date of Study Completion (India) 20/02/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  
Psychological distress, specifically cognitive deficits that arise after cancer related treatment can affect an individual’s daily functioning and quality of life. Several studies reported psychological concerns, memory and cognitive deficits in breast cancer patients and survivors. This study aimed to find Memory, Cognitive function and pattern of Distress among Breast Cancer patients and Survivors. Prospective Cross Sectional study design was used in the study. Women aged between 20 and 60 years, diagnosed with (Stages I/II/III) Breast Cancer planned for or underwent curative intent chemotherapy were included in the study. There were 79 study participants which included survivors (N=27), post-chemotherapy patients (N=27) and pre-chemotherapy patients (N=25). Participants were assessed using Post-Graduate Institute Memory Scale (PGIMS), Montreal Cognitive Assessment (MoCA), NCCN Distress Thermometer and Distress Inventory - Cancer Version 2 (DICV2). Independent-sample t-test, Pearson Correlation Coefficient, ANOVA and Post hoc tests were used to analyse the data. Majority of the survivors and post-chemotherapy patients had increased cognitive impairment when compared to the pre-chemotherapy patients. Though not significant, it was found that memory impairment was greater among post chemotherapy patients and survivors. A significant positive relationship between Memory and Cognitive function and a significant negative relationship between Memory and Distress were found. Participants with higher levels of education had better cognitive functioning and memory levels and older people found to have deterioration in memory. The study concluded there was Cognitive decline and Distress among Breast cancer patients and survivors after completing chemotherapy. The study highlights the importance of appropriate psychotherapeutic interventions for the management of distress and cognitive difficulties among breast cancer patients and survivors during and after treatment.


 
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