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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05856656
Other study ID # ICO-2022-21
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2023
Est. completion date September 2025

Study information

Verified date June 2023
Source Institut Cancerologie de l'Ouest
Contact Sandra PIQUIN
Phone + 33 2 41 35 27 00
Email sandra.piquin@ico.unicancer.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 27
Est. completion date September 2025
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Music therapy
Music therapy is a technique of care, accompaniment and support, which aims to improve health and well-being.

Locations

Country Name City State
France Institut de Cancérologie de l'Ouest Angers

Sponsors (1)

Lead Sponsor Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the impact of music therapy on anxiety in breast cancer patients undergoing adjuvant or neoadjuvant chemotherapy. Changes in anxiety before the first and third chemotherapy sessions will be measured using the State Trait Anxiety Inventory (= STAI etat score). 5 months
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