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CTRI Number  CTRI/2025/03/082872 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 11/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Psychological factors affecting the qualitity of life among patients with cancer of the digestive system 
Scientific Title of Study   Relationship between self-compassion and emotional regulation on the qualitity of life among patients with adenocarcinoma of the digestive system 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neha R 
Designation  Post graduate student  
Affiliation  Manipal College of Health Professions 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of higher Education

Bangalore
KARNATAKA
560017
India 
Phone  9384576789  
Fax  -  
Email  neha.mhsblr2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Jeeshma Vijin 
Designation  Assistant professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of higher Education

Bangalore
KARNATAKA
560017
India 
Phone  08217723829  
Fax  -  
Email  jeeshma.vijin@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Jeeshma Vijin 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of higher Education

Bangalore
KARNATAKA
560017
India 
Phone  08217723829  
Fax  -  
Email  jeeshma.vijin@manipal.edu  
 
Source of Monetary or Material Support  
No.98, Rustam Bagh Road, Old Airport Road, Department of Clinical Psychology, Manipal College of Health Professions,Manipal Academy of Higher Education, Bangalore 560017  
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal  
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 
Neha R  Manipal Hospital  Manipal Hospital Department of Oncology 1st Floor Old Airport Road
Bangalore
KARNATAKA 
9384576789
-
neha.mhsblr2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Manipal Hospitals Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C210||Malignant neoplasm of anus, unspecified, (2) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (3) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified, (4) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, (5) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified, (6) ICD-10 Condition: C20||Malignant neoplasm of rectum, (7) ICD-10 Condition: C179||Malignant neoplasm of small intestine, unspecified, (8) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Individuals above the age of 18
2. Both males and females
3. Patients undergoing Radiotherapy and chemotherapy.
4. Patient with cancer at heterogeneous sites of the digestive system such as the stomach, intestine, esophagus,
mouth, anus, etc 
 
ExclusionCriteria 
Details  1. Cancer Patients who have not been formally diagnosed.
2. Patients who have remitted
3. Patients who have survived cancer.
4. Patients who are not in the initial stage of their diagnosis  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Quality of life  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Emotional regulation  Baseline 
Self-compassion  Baseline 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="51" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/04/2029 
Date of Study Completion (India) 15/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
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  

The diagnosis of cancer can cause distress, especially during the initial stage of the diagnosis. This psychological distress experienced by patients with cancer as a reaction to their diagnosis depends upon various factors such as the personality of the patient, their socio-economic status, and social environment along with other factors such as the site of cancer, stage at diagnosis, and symptoms of the disease. Along with these factors, the distress caused due to diagnosis can also be impacted by emotional, physical, and psychological variables. Many negative emotions such as anger and blame can result from being diagnosed with cancer, which can hinder the management of the disease and affect the patient’s quality of life. 


Quality of life is the overall well-being that consists of objective as well as subjective measures of materialistic, physical, social, and emotional well-being along with the personal development of the individual. From a psychological perspective, self-compassion and emotion regulation have the potential to reduce distress and improve the quality of life. This finding has shown good support among non-clinical populations but mixed support in clinical populations. Thus to address this gap, this current study aims to understand the relationship between self-compassion and the role of emotional regulation on the quality of life among patients diagnosed with adenocarcinoma of the digestive system.


 
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