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

Completed

• Conditions: Benign neoplasm of unspecified breast,

• Registration Number: CTRI/2022/03/041283
• Lead Sponsor: Blessy Mohandass

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-04
• Study Completion: 2024-07-31
• Last Update Posted: 2025-05-17

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Fatigue Scores	Four weeks and Six Weeks
Mean nutritional status score	Four weeks and Six Weeks
Mean Anxiety Scores	Four weeks and Six Weeks
Mean Sleep Quality Index	Four weeks and Six Weeks
Mean Depression Score	Four weeks and Six Weeks

Secondary Outcome Measures

Name	Time	Method
User Satisfaction for MCI	Six Weeks

Trial Locations

Locations (1)

Fortis Hospital, Mohali, Punjab; 🇮🇳 Patiala, PUNJAB, India

Fortis Hospital, Mohali, Punjab

🇮🇳Patiala, PUNJAB, India

Dr Narendra Kumar Bhalla

Principal investigator

8284011897

narendra.bhalla@fortishealthcare.com