Behavior Change Wheel-Based Music Listening for Chemotherapy-Related Cognitive Impairment in Breast Cancer Patients (BCW-MUSIC)
2026年6月7日 更新者：Weijuan Yang、The First Affiliated Hospital with Nanjing Medical University
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
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.
研究概览
详细说明
This is a single-center, assessor-blinded, parallel-group randomized controlled trial designed to evaluate the effectiveness of a Behavior Change Wheel-based music listening intervention for chemotherapy-related cognitive impairment in breast cancer patients.
Eligible participants were adult female patients with histopathologically confirmed breast cancer who received chemotherapy.
A total of 90 participants were randomly assigned in a 1:1 ratio to either the intervention group or the control group.
Participants in the intervention group received routine nursing care plus a 12-week BCW-based music listening intervention, which included relationship building, health education, family involvement, individualized planning, self-training, behavioral reinforcement, and regular feedback.
Participants were instructed to listen to self-selected music for at least 20 minutes per day.
Participants in the control group received routine nursing care, including health education, educational materials, online support, and regular follow-up.
The primary outcome was the change in Functional Assessment of Cancer Therapy-Cognitive Function total score from baseline to Week 12. Secondary outcomes included FACT-Cog subscale scores and PROMIS anxiety and depression scores.
Primary analyses followed the intention-to-treat principle, and analysis of covariance was used to compare post-intervention outcomes between groups while adjusting for baseline values.
The study was approved by the Ethics Committee of The First Affiliated Hospital of Nanjing Medical University.
Written informed consent was obtained from all participants before enrollment.
This study was registered retrospectively after completion of participant enrollment and follow-up.
研究类型
介入性
注册 (实际的)
90
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Jiangsu
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Nanjing、Jiangsu、中国、210029
- The First Affiliated Hospital of Nanjing Medical University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：BCW-Based Music Listening Intervention Group
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.
|
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.
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有源比较器：Routine Care Control Group
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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Functional Assessment of Cancer Therapy-Cognitive Function Total Score
大体时间：Baseline and Week 12
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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.
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Baseline and Week 12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in FACT-Cog Perceived Cognitive Impairment Subscale Score
大体时间：Baseline and Week 12
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Change in the perceived cognitive impairment subscale score of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) from baseline to Week 12. Higher scores indicate better perceived cognitive function.
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Baseline and Week 12
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Change in FACT-Cog Comments From Others Subscale Score
大体时间：Baseline and Week 12
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Change in the comments from others subscale score of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) from baseline to Week 12. Higher scores indicate better perceived cognitive function.
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Baseline and Week 12
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Change in FACT-Cog Perceived Cognitive Abilities Subscale Score
大体时间：Baseline and Week 12
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Change in the perceived cognitive abilities subscale score of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) from baseline to Week 12. Higher scores indicate better perceived cognitive function.
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Baseline and Week 12
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Change in FACT-Cog Impact on Quality of Life Subscale Score
大体时间：Baseline and Week 12
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Change in the impact on quality of life subscale score of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) from baseline to Week 12. Higher scores indicate less impact of cognitive symptoms on quality of life.
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Baseline and Week 12
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Change in PROMIS Depression Short Form Score
大体时间：Baseline and Week 12
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Change in depressive symptoms assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form from baseline to Week 12.
The scale includes 8 items scored on a 5-point Likert scale.
Higher scores indicate more severe depressive symptoms.
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Baseline and Week 12
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年3月1日
初级完成 (实际的)
2025年12月30日
研究完成 (实际的)
2025年12月31日
研究注册日期
首次提交
2026年6月7日
首先提交符合 QC 标准的
2026年6月7日
首次发布 (实际的)
2026年6月11日
研究记录更新
最后更新发布 (实际的)
2026年6月11日
上次提交的符合 QC 标准的更新
2026年6月7日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- NMU-BCW-MUSIC-CRCI-2025 (其他标识符：The First Affiliated Hospital of Nanjing Medical University)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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.
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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.