An experimental study to evaluate the effectiveness of Multi-component Intervention (MCI) on Radiotherapy Induced Fatigue and its correlates among breast cancer patients.

Blessy Mohandass1 site in 1 country100 target enrollmentStarted: April 4, 2022Last updated: May 17, 2025

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor
Enrollment: 100
Locations: 1
Primary Endpoint: Mean Fatigue Scores

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type: Interventional
Allocation: Coin toss, Lottery, toss of dice, shuffling cards etc
Masking: Open Label

Eligibility Criteria

Ages: 18.00 Year(s) to 70.00 Year(s) (—)
Sex: Female

Inclusion Criteria

•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.

Exclusion Criteria

•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.