Anxiety, Breast Cancer, Chemotherapy
Conditions
Brief summary
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.
Interventions
BEHAVIORALMusic therapy
Music therapy is a technique of care, accompaniment and support, which aims to improve health and well-being.
Sponsors
Institut Cancerologie de l'Ouest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with localized breast cancer * Indication for adjuvant or neoadjuvant chemotherapy * Patient \> 18 years of age * Patient with signed consent * Patient affiliated to a social security scheme
Exclusion criteria
* Metastatic patient * Triple negative patient * Patient not eligible for curative surgery * Patient who has already received chemotherapy * Unaided deaf patient * Women who are pregnant, likely to be pregnant or breastfeeding * A patient presenting a depressive episode or a psychotic pathology at the time of the initial consultation * Patient who does not understand French * Cognitive disorder or inability to understand, * Patient protected by law, under court protection, guardianship or curatorship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Score of State Trait Anxiety Inventory Before and After Chemotherapy | 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. |
Countries
France
Contacts
STUDY_DIRECTORSandra PIQUIN
Institut de Cancérologie de l'Ouest
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Age, Continuous | 52.3 years STANDARD_DEVIATION 14.6 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment France | 9 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 0 Participants |
| State Anxiety Score (STAI-State) | 42.8 units on a scale STANDARD_DEVIATION 13 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 9 |
| other Total, other adverse events | 0 / 18 | 0 / 9 |
| serious Total, serious adverse events | 0 / 18 | 0 / 9 |
Outcome results
None listed