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Trial Title:
Music Therapy as a Tool for Anxiety Reduction in Localized Breast Cancer
NCT ID:
NCT05856656
Condition:
Anxiety
Breast Cancer
Chemotherapy
Conditions: Official terms:
Breast Neoplasms
Anxiety Disorders
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Music therapy
Description:
Music therapy is a technique of care, accompaniment and support, which aims to improve
health and well-being.
Arm group label:
Music therapy arm
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut de Cancérologie de l'Ouest
Address:
City:
Angers
Zip:
49055
Country:
France
Contact:
Last name:
Sandra PIQUIN
Email:
sandra.piquin@ico.unicancer.fr
Contact backup:
Last name:
Marine TIGREAT
Email:
marine.tigreat@ico.unicancer.fr
Start date:
September 2023
Completion date:
September 2025
Lead sponsor:
Agency:
Institut Cancerologie de l'Ouest
Agency class:
Other
Source:
Institut Cancerologie de l'Ouest
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05856656
