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

NCT ID: NCT05856656

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2025-06-27

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.

Conditions

Anxiety; Breast Cancer; Chemotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Music therapy arm

A music therapy will be offered to patients before the first 3 chemotherapy cycles

Group Type: EXPERIMENTAL

Music therapy

Intervention Type: BEHAVIORAL

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

Standard care arm

Standard patient care, no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music therapy

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra PIQUIN

Role: STUDY_DIRECTOR

Institut de Cancérologie de l'Ouest

Locations

Institut de Cancérologie de l'Ouest

Angers, , France

Countries

France

Other Identifiers

ICO-2022-21

Identifier Type: -

Identifier Source: org_study_id