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Breast cancer is the number one cancer in women worldwide, with 58,500 new cases in metropolitan France in 2018. The announcement of the cancer, the treatment methods and their side effects can generate unpleasant emotions, such as fear, for example, and the resources for coping with them differ according to the patient. Coming to the hospital as an outpatient for chemotherapy is in itself a source of anxiety.
The use of music in the treatment process is a therapy that can help patients to reduce the intensity of their unpleasant emotions. Active music therapy involves the patient playing an instrument, including voice and body movement in rhythm, without requiring any musical skills. The presence of a qualified music therapy professional is essential, particularly in the reception of the emotions that may be generated during the sessions. These sessions can be collective or individual. In breast cancer, music therapy has been shown to be effective in reducing pain, anxiety, depressive symptoms and length of hospitalisation in patients undergoing mastectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music therapy arm | Experimental | A music therapy will be offered to patients before the first 3 chemotherapy cycles |
|
| Standard care arm | No Intervention | Standard patient care, no intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music therapy | Behavioral | Music therapy is a technique of care, accompaniment and support, which aims to improve health and well-being. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Score of State Trait Anxiety Inventory Before and After Chemotherapy | 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. | From baseline to the end of Cycle 3 (each cycle is 21 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra PIQUIN | Institut de Cancérologie de l'Ouest | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de l'Ouest | Angers | 49055 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Standard Care Arm | Standard patient care, no intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Standard Care Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Score of State Trait Anxiety Inventory Before and After Chemotherapy | 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. | Posted | Mean | Standard Deviation | Score difference | From baseline to the end of Cycle 3 (each cycle is 21 days) |
|
6 months
Adverse events were monitored during the study period. No adverse events were observed or reported in either group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mme Sandra PIQUIN | Institut de Cancérologie de l'Ouest | 02 41 35 27 00 | +33 | sandra.piquin@ico.unicancer.fr |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 4, 2023 | Mar 31, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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Standard patient care, no intervention |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| State Anxiety Score (STAI-State) | State anxiety score measured using the STAI-State scale (range 20-80) before the start of chemotherapy. Higher scores indicate greater anxiety (worse outcome) | Mean | Standard Deviation | units on a scale |
|
| OG001 | Standard Care Arm | Standard patient care, no intervention |
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Standard Care Arm | Standard patient care, no intervention | 0 | 9 | 0 | 9 | 0 | 9 |
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| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |