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OpenTrials
Completed

NCT Number: NCT05856656

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie de l'Ouest

Angers, 49055, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music Therapy

Behavioral

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

Primary outcomes

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

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

    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.

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Acronym: CENSORIAL

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 12, 2023
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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