| 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
|
|
|
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
|
|
|
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.
|