Music Therapy in Patients With Breast Cancer (IMPACT)

NCT07549685 | Enrolling By Invitation

• 1 other identifier: ConsAL - IMPACT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

Medical Music Therapy; Quality of life; Anxiety; Distress; Pain; Cancer; Woman; Integrative

Outcome Measures

Primary Outcomes (1)

• State-Trait Anxiety Inventory

  Level of anxiety ( score 20-80)

  Every single session : 5 minutes before and 10 minutes after

Secondary Outcomes (5)

• Self-Rating Depression Scale (SDS),

  Baseline (T0) - At the end of Cycle 1 (each cycle is 28 days) (T1) - At the end of Cycle 2 (each cycle is 28 days) (T2) - through study completion, up to 4 month (T3)

• Quality of Life (QoL)

  Baseline (T0) - At the end of Cycle 1 (each cycle is 28 days) (T1) - At the end of Cycle 2 (each cycle is 28 days) (T2) - through study completion, up to 4 month (T3)

• Emotion Thermometers (ET)

  every single session: 5 minutes before and 10 minutes after.

• Visual Analogue Scale (VAS)

  pre-post sessions

• Pittsburgh Sleep Quality Index (PSQI).

  Baseline (T0) - At the end of Cycle 1 (each cycle is 28 days) (T1) - At the end of Cycle 2 (each cycle is 28 days) (T2) - through study completion, up to 4 month (T3)

Study Arms (2)

Group 1-Musictherapy A

ACTIVE COMPARATOR

Music therapy in phase A1 and B1, no music therapy in phase A2 and B2

Other: Music Therapy

Group 2 -Musictherapy B

ACTIVE COMPARATOR

Music therapy in phase A2 and B2, no music therapy in phase A1 and B1

Other: Music Therapy

Interventions

Music Therapy OTHER

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

Group 1-Musictherapy A; Group 2 -Musictherapy B

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo - Alessandria

Alessandria, 15121, Italy

Location

Related Publications (6)

• Giordano F, Rutigliano C, Ugolini C, Iacona E, Ronconi L, Raguseo C, Perillo T, Rosa A, Santoro N, Testoni I. Effect of Music Therapy on Chemotherapy Anticipatory Symptoms in Adolescents: A Mixed Methods Study. J Pain Symptom Manage. 2024 Jul;68(1):e62-e74. doi: 10.1016/j.jpainsymman.2024.04.019. Epub 2024 Apr 27.

  PMID: 38679306 BACKGROUND

• Palmer JB, Lane D, Mayo D, Schluchter M, Leeming R. Effects of Music Therapy on Anesthesia Requirements and Anxiety in Women Undergoing Ambulatory Breast Surgery for Cancer Diagnosis and Treatment: A Randomized Controlled Trial. J Clin Oncol. 2015 Oct 1;33(28):3162-8. doi: 10.1200/JCO.2014.59.6049. Epub 2015 Aug 17.

  PMID: 26282640 BACKGROUND

• Bradt J, Potvin N, Kesslick A, Shim M, Radl D, Schriver E, Gracely EJ, Komarnicky-Kocher LT. The impact of music therapy versus music medicine on psychological outcomes and pain in cancer patients: a mixed methods study. Support Care Cancer. 2015 May;23(5):1261-71. doi: 10.1007/s00520-014-2478-7. Epub 2014 Oct 17.

  PMID: 25322972 BACKGROUND

• Bradt J, Dileo C, Myers-Coffman K, Biondo J. Music interventions for improving psychological and physical outcomes in people with cancer. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD006911. doi: 10.1002/14651858.CD006911.pub4.

  PMID: 34637527 BACKGROUND

• Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.

  PMID: 38572751 BACKGROUND

• Chang L, Wang Y, Zhang J, Zhao W, Li X, Yang L. Effect of music therapy combined with aerobic exercise on sleep quality among breast cancer patients undergoing chemotherapy after a radical mastectomy: a randomized controlled trial. BMC Womens Health. 2024 Jul 18;24(1):408. doi: 10.1186/s12905-024-03241-6.

  PMID: 39026220 BACKGROUND

Related Links

• website of PNRR project

MeSH Terms

Conditions

Breast Neoplasms; Anxiety Disorders; Pain; Neoplasms

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Patrizia Santinon, MD

  Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo - Alessandria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Music therapy will be provided in group sessions lasting 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 session will be conducted by qualified music therapist affiliated with "Antonio Vivaldi" Conservatory of Music in Alessandria and the "A. Scarlatti" Conservatory of Music in Palermo, with support from trained doctoral students when required. At the end of each session, participants receiving MT will be provide with customized playlists prepared by the music therapist. Each playlist will last approximately 20 minutes and will be designed to support relaxation and improve sleep quality. Study procedures The study consists of four consecutive phases (A-1,B-1,A-2 and B-2), each lasting 4 weeks. Participants will be randomly assigned to two groups (GR1 and GR2), which will alternate between periods with MT and periods without MT.

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 24, 2026
• Study Start: November 12, 2025
• Primary Completion: March 11, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)