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Enrolling by invitation Not applicable

Music Therapy in Patients With Breast Cancer (IMPACT)

NCT07549685 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto di Studi Superiori Musicali (ISSM) Conservatorio Antonio Vivaldi di Alessandria
Phase
Not applicable
Started
2025-11-12
Last updated
2026-04-24

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Music Therapy

Music Therapy: Group sessions of music therapy last approximately 60 minutes, on a weekly basis. Sessions will include both receptive (eg guided listening and music imagery) and active techniques (eg instrumental or vocal improvisation, songwriting). All the sessions will be conducted by a qualified music therapist

Study summary

This study aims to evaluate the feasibility and potential benefits of music therapy in patients with breast cancer undergoing adjuvant chemotherapy.

Breast cancer patients often experience significant physical and psychological symptoms during treatment, including anxiety, fatigue and reduced quality of life. Music therapy is a promising non-pharmacological intervention that may help improve psychological well-being and symptom management. However, current evidence is mainly based on group-level studies and does not account for individual variability in response.

This pilot study is designed as a series of combined N-of-1 trials, in which each participant alternates periods with and without music therapy, acting as her own control. A total of 24 patients will be recruited from two Italian oncology centres and randomly assigned to different intervention sequences.

The intervention consists of weekly group music therapy sessions lasting approximately 60 minutes, including both active and receptive techniques, along with personalized music playlists for home use.

The primary objective is to assess the feasibility of this study design, including recruitment, retention, data completeness and acceptability of the intervention. Secondary objectives include exploring the effects of music therapy on psychological and physical well-being, as well as estimating variability in individual responses.

The results of this study will inform the design of future larger studies aimed at evaluating the effectiveness of music therapy using personalised trial approaches.

Eligibility

Sex
FEMALE
Min age
25 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: Participants will be eligible for inclusion if they meet all of the following criteria: - women age 25-75 years; * histologically confirmed diagnosis of BC; * undergoing adjuvant chemotherapy following surgery; * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; * ability to understand the Italian language and comply with study procedures; * provide written informed consent to study participation. Exclusion Criteria: Participants will be excluded if they meet any of the following criteria: * active neurological disorders; * active psychiatric disorders; * current or past substance abuse; * significant uncorrected visual, auditory or speech impairments; * have primary or metastatic brain tumours, as confirmed clinically or radiologically; * any condition that, in the opinion of the investigators, may interfere with participation in the study.

Primary outcome measure(s)

  • State-Trait Anxiety Inventory — Every single session : 5 minutes before and 10 minutes after
    Level of anxiety ( score 20-80)

Trial sites (1)

FacilityCityRegionStatus
Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo - Alessandria Alessandria Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07549685 on ClinicalTrials.gov ↗ ← All trials in Italy