Breast Cancer, Chemotherapy-Related Cognitive Impairment
Conditions
Keywords
Breast Cancer, Chemotherapy-Related Cognitive Impairment, Music Listening, Behavior Change Wheel, FACT-Cog, PROMIS Anxiety, PROMIS Depression
Brief 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.
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.
Interventions
BEHAVIORALBCW-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.
BEHAVIORALRoutine 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.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the music listening intervention, participants and care providers could not be blinded. Outcome assessors were blinded to group allocation during questionnaire assessment and data collection.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Assessment of Cancer Therapy-Cognitive Function Total Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in FACT-Cog Perceived Cognitive Impairment Subscale Score | 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. |
| Change in FACT-Cog Comments From Others Subscale Score | 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. |
| Change in FACT-Cog Perceived Cognitive Abilities Subscale Score | 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. |
| Change in FACT-Cog Impact on Quality of Life Subscale Score | 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. |
| Change in PROMIS Depression Short Form Score | 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. |
Countries
China
Outcome results
None listed