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

Sponsor
Institut Cancerologie de l'Ouest (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05856656
Collaborator
(none)
27
2
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Music therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
27 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Music Therapy as a Tool for Anxiety Reduction in Localized Breast Cancer
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Music therapy arm

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

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

No Intervention: Standard care arm

Standard patient care, no intervention

Outcome Measures

Primary Outcome Measures

  1. To evaluate the impact of music therapy on anxiety in breast cancer patients undergoing adjuvant or neoadjuvant chemotherapy. [5 months]

    The evolution of anxiety before the first and before the 3rd chemotherapy session, measured by the questionnaire STAI etat score.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Institut Cancerologie de l'Ouest

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier:
NCT05856656
Other Study ID Numbers:
  • ICO-2022-21
First Posted:
May 12, 2023
Last Update Posted:
May 12, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 12, 2023