Breast CancerBCW-MUSICNCT07641114
Behavior Change Wheel-Based Music Listening for Chemotherapy-Related Cognitive Impairment in Breast Cancer Patients
A study testing BCW-Based Music Listening Intervention and Routine Nursing Care in people with Breast Cancer and Chemotherapy-Related Cognitive Impairment, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Chemotherapy-Related Cognitive Impairment
- What is being tested?
- BCW-Based Music Listening Intervention and Routine Nursing Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Being tested
- BCW-Based Music Listening Intervention, Routine Nursing Care
- Keywords
- Breast Cancer, Chemotherapy-Related Cognitive Impairment, Music Listening, Behavior Change Wheel, FACT-Cog, PROMIS Anxiety, PROMIS Depression
- Medical subject headings
- Breast Neoplasms, Chemotherapy-Related Cognitive Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCW-Based Music Listening InterventionBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BCW-Based Music Listening Intervention Group | Experimental | 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. Receives: Behavioral: BCW-Based Music Listening Intervention; Behavioral: Routine Nursing Care |
| Routine Care Control Group | Active comparator | 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. Receives: Behavioral: Routine Nursing Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Assessment of Cancer Therapy-Cognitive Function Total Score
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.
Measured: Baseline and Week 12
Secondary outcomes (5)
Change in FACT-Cog Perceived Cognitive Impairment Subscale Score
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.
Measured: Baseline and Week 12
Change in FACT-Cog Comments From Others Subscale Score
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.
Measured: Baseline and Week 12
Change in FACT-Cog Perceived Cognitive Abilities Subscale Score
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.
Measured: Baseline and Week 12
Change in FACT-Cog Impact on Quality of Life Subscale Score
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.
Measured: Baseline and Week 12
Change in PROMIS Depression Short Form Score
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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Mar 2025
- Primary completion30 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to either the Behavior Change Wheel-based music listening intervention group or the routine care control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijuan Yang, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641114
- Sponsor's protocol ID
- NMU-BCW-MUSIC-CRCI-2025
- Other IDs
- NMU-BCW-MUSIC-CRCI-2025
- Acronym
- BCW-MUSIC
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07641114
- Acronym / sponsor ID
- BCW-MUSIC / NMU-BCW-MUSIC-CRCI-2025
- Keywords
- Breast Cancer, Chemotherapy-Related Cognitive Impairment, Music Listening, Behavior Change Wheel, FACT-Cog, PROMIS Anxiety, PROMIS Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to either the Behavior Change Wheel-based music listening intervention group or the routine care control group.
| Arm | Type | Receives |
|---|---|---|
| BCW-Based Music Listening Intervention Group | Experimental | Behavioral: BCW-Based Music Listening Intervention, Behavioral: Routine Nursing CareParticipants 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. |
| Routine Care Control Group | Active comparator | Behavioral: Routine Nursing CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCW-Based Music Listening InterventionThe 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. | Behavioural | BCW-Based Music Listening Intervention Group |
| Routine Nursing CareRoutine 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. | Behavioural | BCW-Based Music Listening Intervention Group, Routine Care Control Group |
Primary outcome
Change in Functional Assessment of Cancer Therapy-Cognitive Function Total Score
Time frame: 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.
5 secondary outcomes
Change in FACT-Cog Perceived Cognitive Impairment Subscale Score
Time frame: Baseline and Week 12
Change in FACT-Cog Comments From Others Subscale Score
Time frame: Baseline and Week 12
Change in FACT-Cog Perceived Cognitive Abilities Subscale Score
Time frame: Baseline and Week 12
Change in FACT-Cog Impact on Quality of Life Subscale Score
Time frame: Baseline and Week 12
Change in PROMIS Depression Short Form Score
Time frame: Baseline and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCW-Based Music Listening Intervention and Routine Nursing Care in people with Breast Cancer and Chemotherapy-Related Cognitive Impairment, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Assessment of Cancer Therapy-Cognitive Function Total Score (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.