Music Therapy as a Tool for Anxiety Reduction in Localized Breast Cancer
CENSORIAL
1 other identifier
interventional
27
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable anxiety
Started Oct 2023
Typical duration for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2023
CompletedFirst Posted
Study publicly available on registry
May 12, 2023
CompletedStudy Start
First participant enrolled
October 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2025
CompletedAugust 17, 2025
July 1, 2025
1.7 years
May 4, 2023
August 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Music therapy arm
EXPERIMENTALA music therapy will be offered to patients before the first 3 chemotherapy cycles
Standard care arm
NO INTERVENTIONStandard patient care, no intervention
Interventions
Music therapy is a technique of care, accompaniment and support, which aims to improve health and well-being.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut de Cancérologie de l'Ouest
Angers, 49055, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sandra PIQUIN
Institut de Cancérologie de l'Ouest
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
August 17, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share