NCT05856656

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

October 10, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2025

Completed
Last Updated

August 17, 2025

Status Verified

July 1, 2025

Enrollment Period

1.7 years

First QC Date

May 4, 2023

Last Update Submit

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

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 therapyBEHAVIORAL

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

Music therapy arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cancérologie de l'Ouest

Angers, 49055, France

Location

MeSH Terms

Conditions

Anxiety DisordersBreast Neoplasms

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental DisordersNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sandra PIQUIN

    Institut de Cancérologie de l'Ouest

    STUDY DIRECTOR

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

Locations