Clinical trial · Interventional
Music Therapy in Patients With Breast Cancer (IMPACT)
Feasibility of N-of-1 Trials to Evaluate Music Therapy in Patients With Breast Cancer Undergoing Adjuvant Chemotherapy: a Multicentre Pilot Study Protocol Integrated Music Therapy Program for Advanced Care in Breast Cancer Treatment (IMPACT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Music Therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group 1-Musictherapy A
- description
- Music therapy in phase A1 and B1, no music therapy in phase A2 and B2
- interventionNames
- Other: Music Therapy
- type
- ACTIVE_COMPARATOR
- label
- Group 2 -Musictherapy B
- description
- Music therapy in phase A2 and B2, no music therapy in phase A1 and B1
- interventionNames
- Other: Music Therapy
Primary outcomes (1)
- measure
- State-Trait Anxiety Inventory
- timeFrame
- Every single session : 5 minutes before and 10 minutes after
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDGiordano 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
- BACKGROUNDPalmer 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
- BACKGROUNDBradt 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
- BACKGROUNDBradt 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
- BACKGROUNDBray 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
- BACKGROUNDChang 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.