Clinical trial · Interventional
Behavior Change Wheel-Based Music Listening for Chemotherapy-Related Cognitive Impairment in Breast Cancer Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy-Related Cognitive Impairment | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCW-Based Music Listening Intervention | Behavioral | — | UNRESOLVED |
| Routine Nursing Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BCW-Based Music Listening Intervention Group
- description
- Participants 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.
- interventionNames
- Behavioral: BCW-Based Music Listening Intervention
- Behavioral: Routine Nursing Care
- type
- ACTIVE_COMPARATOR
- label
- Routine Care Control Group
- description
- Participants 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histopathologically confirmed breast cancer. 2. Female patients aged 18 years or older. 3. Patients receiving chemotherapy with at least six planned cycles. 4. Able to understand the study procedures and complete the required questionnaires. 5. Provided written informed consent and voluntarily agreed to participate. Exclusion Criteria: 1. Visual, hearing, or speech impairment that may affect participation in the intervention or outcome assessment. 2. Cognitive impairment caused by other diseases. 3. Metastatic breast cancer or cachexia. 4. Receiving other interventions specifically targeting cognitive impairment.
References
Publications (0)
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