Behavior Change Wheel-Based Music Listening for Chemotherapy-Related Cognitive Impairment in Breast Cancer Patients
BCW-MUSIC
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
1 other identifier
interventional
90
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Mar 2025
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedFirst Submitted
Initial submission to the registry
June 7, 2026
CompletedFirst Posted
Study publicly available on registry
June 11, 2026
CompletedJune 11, 2026
June 1, 2026
10 months
June 7, 2026
June 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Functional Assessment of Cancer Therapy-Cognitive Function Total Score
The primary outcome was the change in the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) total score from baseline to Week 12. The FACT-Cog includes 37 items scored on a 0 to 4 Likert scale, with a total score ranging from 0 to 148. Higher scores indicate better perceived cognitive function.
Baseline and Week 12
Secondary Outcomes (5)
Change in FACT-Cog Perceived Cognitive Impairment Subscale Score
Baseline and Week 12
Change in FACT-Cog Comments From Others Subscale Score
Baseline and Week 12
Change in FACT-Cog Perceived Cognitive Abilities Subscale Score
Baseline and Week 12
Change in FACT-Cog Impact on Quality of Life Subscale Score
Baseline and Week 12
Change in PROMIS Depression Short Form Score
Baseline and Week 12
Study Arms (2)
BCW-Based Music Listening Intervention Group
EXPERIMENTALParticipants in this group received routine nursing care plus a Behavior Change Wheel-based music listening intervention for 12 weeks. The intervention 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.
Routine Care Control Group
ACTIVE COMPARATORParticipants in this group received routine nursing care, including 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Histopathologically confirmed breast cancer.
- Female patients aged 18 years or older.
- Patients receiving chemotherapy with at least six planned cycles.
- Able to understand the study procedures and complete the required questionnaires.
- Provided written informed consent and voluntarily agreed to participate.
You may not qualify if:
- Visual, hearing, or speech impairment that may affect participation in the intervention or outcome assessment.
- Cognitive impairment caused by other diseases.
- Metastatic breast cancer or cachexia.
- Receiving other interventions specifically targeting cognitive impairment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Due to the nature of the music listening intervention, participants and care providers could not be blinded. Outcome assessors were blinded to group allocation during questionnaire assessment and data collection.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 7, 2026
First Posted
June 11, 2026
Study Start
March 1, 2025
Primary Completion
December 30, 2025
Study Completion
December 31, 2025
Last Updated
June 11, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be publicly shared because the study data contain personal health information, questionnaire responses, and clinical treatment information. Public sharing may increase the risk of participant identification. Data access is restricted by participant privacy protection requirements and institutional data management policies. Researchers with reasonable academic requests may contact the principal investigator, and any data access will be subject to approval by the study institution and ethics committee.