Trial Outcomes & Findings for Music Therapy as a Tool for Anxiety Reduction in Localized Breast Cancer (NCT NCT05856656)
NCT ID: NCT05856656
Last Updated: 2026-06-08
Results Overview
The State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-State, Form Y-A) will be used to assess patients' anxiety levels. The score ranges from 20 to 80, with higher scores indicating greater anxiety. For each chemotherapy cycle, the STAI-State score will be collected immediately before and immediately after chemotherapy administration. The outcome measure corresponds to the change in STAI-State score (post-chemotherapy minus pre-chemotherapy) for each cycle. The primary analysis compares the mean change in STAI-State scores between the music therapy group and the control group, calculated as the average of the pre-post differences across the first three chemotherapy cycles.
COMPLETED
NA
27 participants
From baseline to the end of Cycle 3 (each cycle is 21 days)
2026-06-08
Participant Flow
Participant milestones
| Measure |
Music Therapy Arm
A music therapy will be offered to patients before the first 3 chemotherapy cycles
Music therapy: Music therapy is a technique of care, accompaniment and support, which aims to improve health and well-being.
|
Standard Care Arm
Standard patient care, no intervention
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
9
|
|
Overall Study
COMPLETED
|
17
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Music Therapy Arm
A music therapy will be offered to patients before the first 3 chemotherapy cycles
Music therapy: Music therapy is a technique of care, accompaniment and support, which aims to improve health and well-being.
|
Standard Care Arm
Standard patient care, no intervention
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Music Therapy Arm
n=18 Participants
A music therapy will be offered to patients before the first 3 chemotherapy cycles
Music therapy: Music therapy is a technique of care, accompaniment and support, which aims to improve health and well-being.
|
Standard Care Arm
n=9 Participants
Standard patient care, no intervention
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=18 Participants
|
9 Participants
n=9 Participants
|
21 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=18 Participants
|
0 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 15.6 • n=18 Participants
|
47.8 years
STANDARD_DEVIATION 11.8 • n=9 Participants
|
52.3 years
STANDARD_DEVIATION 14.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=18 Participants
|
9 Participants
n=9 Participants
|
27 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=18 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
18 participants
n=18 Participants
|
9 participants
n=9 Participants
|
27 participants
n=27 Participants
|
|
State Anxiety Score (STAI-State)
|
44.2 units on a scale
STANDARD_DEVIATION 12.6 • n=18 Participants
|
40.1 units on a scale
STANDARD_DEVIATION 14.2 • n=9 Participants
|
42.8 units on a scale
STANDARD_DEVIATION 13.0 • n=27 Participants
|
PRIMARY outcome
Timeframe: From baseline to the end of Cycle 3 (each cycle is 21 days)The State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-State, Form Y-A) will be used to assess patients' anxiety levels. The score ranges from 20 to 80, with higher scores indicating greater anxiety. For each chemotherapy cycle, the STAI-State score will be collected immediately before and immediately after chemotherapy administration. The outcome measure corresponds to the change in STAI-State score (post-chemotherapy minus pre-chemotherapy) for each cycle. The primary analysis compares the mean change in STAI-State scores between the music therapy group and the control group, calculated as the average of the pre-post differences across the first three chemotherapy cycles.
Outcome measures
| Measure |
Music Therapy Arm
n=18 Participants
A music therapy will be offered to patients before the first 3 chemotherapy cycles
Music therapy: Music therapy is a technique of care, accompaniment and support, which aims to improve health and well-being.
|
Standard Care Arm
n=9 Participants
Standard patient care, no intervention
|
|---|---|---|
|
Change in Score of State Trait Anxiety Inventory Before and After Chemotherapy
|
-7.9 Score difference
Standard Deviation 7.7
|
-2.3 Score difference
Standard Deviation 5.0
|
Adverse Events
Music Therapy Arm
Standard Care Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mme Sandra PIQUIN
Institut de Cancérologie de l'Ouest
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place