Behavior Change Wheel-Based Music Listening for Chemotherapy-Related Cognitive Impairment in Brea… (NCT07641114) | Clinical Trial Compass
CompletedNot Applicable
Behavior Change Wheel-Based Music Listening for Chemotherapy-Related Cognitive Impairment in Breast Cancer Patients
China90 participantsStarted 2025-03-01
Plain-language 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.
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a Behavior Change Wheel-based music listening program to address chemo-related cognitive impairment in breast cancer patients — since it's already completed, has my care team seen any of its findings, and do they think this kind of approach could be relevant for me?
2The trial measured changes in cognitive function using a specific tool called the Functional Assessment of Cancer Therapy-Cognitive Function scale — can you walk me through what that scale actually measures, and how significant any changes found in this study would need to be to make a real difference in daily life?
3Since this trial was listed as 'Phase NA,' meaning it wasn't a traditional drug trial testing safety and dosing in phases, does that change how much confidence we can have in its results compared to a standard Phase 2 or Phase 3 clinical trial?
4If chemotherapy-related cognitive impairment is a concern for me, are there already evidence-based strategies — like this music listening approach or others — that you'd recommend I try alongside or after my chemotherapy treatment?
5Since this trial focused specifically on breast cancer patients receiving chemotherapy, how closely does my own treatment plan match what was studied, and does that affect whether its findings might apply to my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Functional Assessment of Cancer Therapy-Cognitive Function Total Score
Timeframe: Baseline and Week 12
Trial details
NCT IDNCT07641114
SponsorThe First Affiliated Hospital with Nanjing Medical University