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

7 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

90

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.
Behawioralne: 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.
Aktywny komparator: 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.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Functional Assessment of Cancer Therapy-Cognitive Function Total Score
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in FACT-Cog Perceived Cognitive Impairment Subscale Score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 marca 2025

Zakończenie podstawowe (Rzeczywisty)

30 grudnia 2025

Ukończenie studiów (Rzeczywisty)

31 grudnia 2025

Daty rejestracji na studia

Pierwszy przesłany

7 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

11 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

11 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

7 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

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

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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