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
|
|
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
|
|
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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