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Music Therapy in Patients With Breast Cancer (IMPACT)

NCT07549685 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-24

No results posted yet for this 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.

Conditions

Interventions

OTHER

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

Sponsors & Collaborators

  • Istituto di Studi Superiori Musicali (ISSM) Conservatorio Antonio Vivaldi di Alessandria

    lead OTHER

Principal Investigators

  • Patrizia Santinon, MD · Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo - Alessandria

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-12
Primary Completion
2026-03-11
Completion
2026-06-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07549685 on ClinicalTrials.gov