| CTRI Number |
CTRI/2024/06/069463 [Registered on: 25/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Psychosocial Intervention for Colorectal Cancer Patients |
|
Scientific Title of Study
|
Effectiveness of Psychosocial Intervention on Distress, Body Image Satisfaction and Quality of Life among Colorectal Cancer Patients: An Intervention 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 Psychooncology |
| Affiliation |
Malabar Cancer Centre |
| Address |
Psycho-Oncology Division, Under department of surgical oncology,OPD 21 and 22, Malabar Cancer Centre, Kodiyeri, Muzhikkara - MCC Rd, Illathaazha, Thalassery, Kerala 670103
Kannur
KERALA
670103
India |
| Phone |
8086767706 |
| Fax |
|
| Email |
jishasarah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Fathimath Naeema Nasreen |
| Designation |
Fellow in Psychooncology |
| Affiliation |
Malabar Cancer Centre |
| Address |
Psycho0oncology division, under surgical oncology department, OPD number 21 and 22, Malabar Cancer Centre, Kodiyeri, Muzhikkara - MCC Rd, Illathaazha, Thalassery, Kerala 670103
Kannur
KERALA
670103
India |
| Phone |
8086767706 |
| Fax |
|
| Email |
naeema.nasreen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jisha Abraham |
| Designation |
Lecturer Psychooncology |
| Affiliation |
Malabar Cancer Centre |
| Address |
Psychooncology division, under surgical oncology division, OPD number 21 and 22, Malabar Cancer Centre, Kodiyeri, Muzhikkara - MCC Rd, Illathaazha, Thalassery, Kerala 670103
Kannur
KERALA
670103
India |
| Phone |
8086767706 |
| Fax |
|
| Email |
jishasarah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Malabar Cancer Centre, Thalassery |
|
|
Primary Sponsor
|
| Name |
Malabar Cancer Centre |
| Address |
Kodiyeri, Muzhikkara - MCC Rd, Illathaazha, Thalassery, Kerala 670103 |
| 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 |
Division of Psycho-Oncology, room number 215 I and 215 J, OP number 21 and OP number 22, Kodiyeri, Muzhikkara - MCC Rd, Illathaazha, Thalassery, Kerala 670103
Kannur
KERALA |
8086767706
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: C187||Malignant neoplasm of sigmoid colon, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Discharge Counselling |
On the date of discharge, the participants will be provided distress management, supportive therapy and psychoeducation.
There will be only one Therapy session of 45 minutes prior to discharge from the ward. |
| Intervention |
Psychosocial Therapy |
3 session intervention that addresses distress, body image satisfaction and quality of life among colorectal cancer patients compared to one session intervention among colorectal cancer patients. The first session will on the date of discharge. The patients will be given the following psychological interventions, Distress Management, Presupposing Change and SFBT Scaling, Awareness Mindfulness Session
and a homework of Gratitude Journalling. One to two weeks after the discharge, the participants will be given their second psychological intervention, which includes, review of the homework,
Presupposing Change and SFBT Scaling, Distress Assessment and Distress Management and Acceptance and Commitment Therapy. Finally the third followup will be one to two weeks after the second session which includes, review of homework, Distress Management
Presupposing Change and SFBT Scaling, Brief PMR and Behaviour Scheduling.
The duration of the therapy session will be 45 minutes. Three Therapy sessions will be conducted in a span of 3 to 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals diagnosed with Colorectal Cancer (Stages I/II/III) .
2. Individuals who underwent curative intent colorectal cancer surgery with or without neoadjuvant treatment.
3. Individuals who can read, write and understand English or Malayalam.
4. 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 or Intellectual Disability.
3. Patients with a known history of epilepsy or other brain related impairments, underwent major cardiovascular surgeries, and neurological conditions.
4. Patients undergoing Palliative intent treatment.
5. Individual with relapse/recurrence/second primary. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement of distress, body image satisfaction, quality of life |
Post surgery after 3 days
3 days to 2 weeks after first follow up
3 days to 2 weeks after second follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| relationship between distress, body image satisfaction and quality of life among colorectal cancer patients |
post surgery - after 3 days
6 days to 4 weeks after first session |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="29" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/07/2024 |
| Date of Study Completion (India) |
01/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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)
|
The study aims to evaluate the effectiveness of psychosocial intervention on distress, body image satisfaction and quality of life among CRC patients who underwent curative intent surgery. To measure these variables, Distress Thermometer (NCCN DT), Body image Scale (BIS), EORTC Quality of Life (EORTC QLQ- C30) and EORTC QLQ – CR29 will be used. The study uses Pretest-Posttest Randomized Control Group Design. The sample size for descriptive study is 94 CRC patients and 12 CRC patients for intervention study (6 in each group). Purposive Sampling will be used for descriptive design. Simple Random sampling will be used for phase 2 intervention study. The intervention phase of the study involves two groups - control group who will be provided with single session conventional intervention and intervention group who will be given 3 session psychosocial intervention module. The participants intervention study will be recruited based on a score of 4 or above on NCCN DT.
|