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

NCT05856656 | Completed Results

• 1 other identifier: ICO-2022-21
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Breast Cancer; Chemotherapy; Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in Score of State Trait Anxiety Inventory Before and After Chemotherapy

  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.

  From baseline to the end of Cycle 3 (each cycle is 21 days)

Study Arms (2)

Music therapy arm

EXPERIMENTAL

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

Behavioral: Music therapy

Standard care arm

NO INTERVENTION

Standard patient care, no intervention

Interventions

Music therapy BEHAVIORAL

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

Music therapy arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

Institut de Cancérologie de l'Ouest

Angers, 49055, France

Location

MeSH Terms

Conditions

Anxiety Disorders; Breast Neoplasms

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Mme Sandra PIQUIN
• Organization: Institut de Cancérologie de l'Ouest

sandra.piquin@ico.unicancer.fr

02 41 35 27 00

Study Officials

• Sandra PIQUIN

  Institut de Cancérologie de l'Ouest

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 12, 2023
• Study Start: October 10, 2023
• Primary Completion: June 27, 2025
• Study Completion: June 27, 2025
• Last Updated: June 8, 2026
• Results First Posted: June 8, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)