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NCT07641114
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Behavior Change Wheel-Based Music Listening for Chemotherapy-Related Cognitive Impairment in Breast Cancer Patients

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

Breast cancer patients frequently experience chemotherapy-related cognitive impairment (CRCI), which can negatively affect memory, attention, executive function, daily activities, and quality of life. Effective non-pharmacological interventions for CRCI remain limited. This randomized controlled trial aims to evaluate the effectiveness of a Behavior Change Wheel (BCW)-based music listening intervention in improving cognitive function among breast cancer patients receiving chemotherapy. A total of 90 eligible participants will be randomly assigned in a 1:1 ratio to either a BCW-based music listening intervention group or a routine care control group. Participants in the intervention group will receive a 12-week music listening program in addition to routine care, while participants in the control group will receive routine care alone. The primary outcome is the change in Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) total score from baseline to the end of the intervention. Secondary outcomes include FACT-Cog subscale scores and PROMIS anxiety and depression scores. This study aims to provide evidence regarding the effectiveness of a theory-based music listening intervention for managing chemotherapy-related cognitive impairment in breast cancer patients. This study was registered retrospectively after completion of participant enrollment and follow-up.

Official title: Effect of a Behavior Change Wheel-Based Music Listening Intervention on Chemotherapy-Related Cognitive Impairment in Breast Cancer Patients: An Assessor-Blinded Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2025-03-01

Completion Date

2025-12-31

Last Updated

2026-06-11

Healthy Volunteers

No

Interventions

BEHAVIORAL

BCW-Based Music Listening Intervention

The intervention was a 12-week Behavior Change Wheel-based music listening program provided in addition to routine nursing care. It included relationship building, health education, family involvement, individualized planning, self-training, behavioral reinforcement, daily music listening, and regular feedback. Participants were instructed to listen to self-selected music for at least 20 minutes per day throughout the intervention period.

BEHAVIORAL

Routine Nursing Care

Routine nursing care included health education after chemotherapy, educational materials, symptom management guidance, dietary advice, relaxation training, medication guidance, psychological support, WeChat-based information sharing, and follow-up consultation every two weeks.

Locations (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China