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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
90
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Jiangsu
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Nanjing、Jiangsu、中国、210029
- The First Affiliated Hospital of Nanjing Medical University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
アクティブコンパレータ：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.
|
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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Functional Assessment of Cancer Therapy-Cognitive Function Total Score
時間枠：Baseline and Week 12
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in FACT-Cog Perceived Cognitive Impairment Subscale Score
時間枠：Baseline and Week 12
|
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
時間枠：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
時間枠：Baseline and Week 12
|
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.
|
Baseline and Week 12
|
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Change in FACT-Cog Impact on Quality of Life Subscale Score
時間枠：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
時間枠：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.
|
Baseline and Week 12
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年3月1日
一次修了 (実際)
2025年12月30日
研究の完了 (実際)
2025年12月31日
試験登録日
最初に提出
2026年6月7日
QC基準を満たした最初の提出物
2026年6月7日
最初の投稿 (実際)
2026年6月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月11日
QC基準を満たした最後の更新が送信されました
2026年6月7日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NMU-BCW-MUSIC-CRCI-2025 (その他の識別子：The First Affiliated Hospital of Nanjing Medical University)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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