Music Therapy as a Tool for Anxiety Reduction in Localized Breast Cancer

Breast Cancer Clinical Trial

— CENSORIAL  

Official title:

Music Therapy as a Tool for Anxiety Reduction in Localized Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05856656
• Other study ID #: ICO-2022-21
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Breast Cancer
• Breast Neoplasms
• Chemotherapy

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