| CTRI Number |
CTRI/2022/03/041283 [Registered on: 22/03/2022] Trial Registered Prospectively |
| Last Modified On: |
17/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
An experimental study to evaluate the effectiveness of Multi-component Intervention (MCI) on Radiotherapy Induced Fatigue and its correlates among breast cancer patients. |
|
Scientific Title of Study
|
An experimental study to evaluate the effectiveness of Multi-component Intervention (MCI) on Radiotherapy Induced Fatigue and its correlates among breast cancer patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Blessy Mohandass |
| Designation |
Assistant Professor |
| Affiliation |
Gian Sagar College of Nursing |
| Address |
Gian Sagar College of Nursing
Gian Sagar Medical College and Hospital
Ramnagar, Rajpura, Punjab-140401
Patiala
PUNJAB
140401
India |
| Phone |
7837593229 |
| Fax |
|
| Email |
blessymohandass@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Blessy Mohandass |
| Designation |
Assistant Professor |
| Affiliation |
Gian Sagar College of Nursing |
| Address |
Gian Sagar College of Nursing
Gian Sagar Medical College and Hospital
Ramnagar, Rajpura, Punjab-140401
Patiala
PUNJAB
140401
India |
| Phone |
7837593229 |
| Fax |
|
| Email |
blessymohandass@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Blessy Mohandass |
| Designation |
Assistant Professor |
| Affiliation |
Gian Sagar College of Nursing |
| Address |
Gian Sagar College of Nursing
Gian Sagar Medical College and Hospital
Ramnagar, Rajpura, Punjab-140401
Patiala
PUNJAB
140401
India |
| Phone |
7837593229 |
| Fax |
|
| Email |
blessymohandass@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Blessy Mohandass |
| Address |
Chitkara School of Health Sciences, Chitkara University, Punjab |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Narendra Kumar Bhalla |
Fortis Hospital, Mohali, Punjab |
Department of Radiation Oncology, Room No 4, Basement 2, Nuclear Medicine Block
Fortis Cancer Institute, Fortis Hospital,
Sector 62, Phase 8, SAS Nagar
Mohali, Punjab-160062
Patiala
PUNJAB |
8284011897
narendra.bhalla@fortishealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Fortis Hospital Mohali (Pb.) ECR/28/Inst/PB/2013/RR-19 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D249||Benign neoplasm of unspecified breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multicomponent Intervention |
Guided imagery: A 15-minute long personalized session that focuses on mental images to evoke feelings of relaxation. A pre-recorded video for continued use during the complete course of treatment.
Information Booklet: A booklet covering topics on nutrition maintenance during Radiation therapy especially for breast cancer patients.
Instant message reminders: Thrice a week message for maintaining compliance to Guided Imagery and nutrition. |
| Comparator Agent |
No Treatment |
No Treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Female Breast cancer patients who are:
above the age of 18 years
willing to participate
prescribed radiation therapy for at least 6 weeks
having smartphone
able to read and understand Hindi or English |
|
| ExclusionCriteria |
| Details |
Females Breast cancer patients
diagnosed with comorbidities like severe depression, cardiovascular diseases, endocrine diseases, and sleep disorders
unable to follow instructions owing to compromised physical and mental health
enrolled in another study that involves a similar intervention
having compliance less than 75% for MCI
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean Fatigue Scores
Mean Anxiety Scores
Mean Depression Score
Mean Sleep Quality Index
Mean nutritional status score |
Four weeks and Six Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| User Satisfaction for MCI |
Six Weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="82" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/04/2022 |
| Date of Study Completion (India) |
31/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Mohandass B, Singh S, Bhalla NK. Radiotherapy induced fatigue and its correlates. Onkologia i Radioterapia. 2023 Sep 15 ;17(9).
Mohandass B, Bhalla NK, Singh S. 25: Multi-component intervention on radiotherapy induced fatigue in Breast cancer patients: A Pilot trial. Radiotherapy and Oncology. 2024 May 1;194:S446-8.
Mohandass B, Singh S, Bhalla NK. Effectiveness of multicomponent intervention on radiotherapy-induced fatigue and its corelates among breast cancer patients. Onkologia i Radioterapia. 2024 Jun 1;18(6). |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a cluster randomized, open label, parallel group, single-centre trial comparing the effectiveness of nurse led multicomponent intervention (MCI) that includes guided imagery, information booklet, weekly messaging reminders for 6 weeks on radiotherapy induced fatigue and its co relates among 100 breast cancer patients receiving radiation therapy that will be conducted in Punjab, India. The primary outcome measures will be Mean Cancer Fatigue Scores, Mean Zung Anxiety Scores, Mean Zung Depression Score, Mean Pittsburg Sleep Quality Index, Mean PG-SGA point Score, Mean Hemoglobin Levels at Four weeks and Six weeks. The secondary outcome will be user satisfaction for MCI at Six weeks. |