Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Behavior Change Wheel-Based Music Listening for Chemotherapy-Related Cognitive Impairment in Breast Cancer Patients (BCW-MUSIC)

7 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

90

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Chine
    • Jiangsu
      • Nanjing, Jiangsu, Chine, 210029
        • The First Affiliated Hospital of Nanjing Medical University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: 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.
Comportemental: 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.
Comparateur actif: 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.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Functional Assessment of Cancer Therapy-Cognitive Function Total Score
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in FACT-Cog Perceived Cognitive Impairment Subscale Score
Délai: 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.
Baseline and Week 12
Change in FACT-Cog Comments From Others Subscale Score
Délai: Baseline and Week 12
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.
Baseline and Week 12
Change in FACT-Cog Perceived Cognitive Abilities Subscale Score
Délai: 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
Change in FACT-Cog Impact on Quality of Life Subscale Score
Délai: Baseline and Week 12
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.
Baseline and Week 12
Change in PROMIS Depression Short Form Score
Délai: Baseline and Week 12
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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

The First Affiliated Hospital with Nanjing Medical University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mars 2025

Achèvement primaire (Réel)

30 décembre 2025

Achèvement de l'étude (Réel)

31 décembre 2025

Dates d'inscription aux études

Première soumission

7 juin 2026

Première soumission répondant aux critères de contrôle qualité

7 juin 2026

Première publication (Réel)

11 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NMU-BCW-MUSIC-CRCI-2025 (Autre identifiant: The First Affiliated Hospital of Nanjing Medical University)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner