Music Therapy in Patients With Breast Cancer (IMPACT) (IMPACT-)

April 17, 2026 updated by: Istituto di Studi Superiori Musicali (ISSM) Conservatorio Antonio Vivaldi di Alessandria

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Breast cancer is the most commonly diagnosed cancer among women worldwide and is frequently associated with a substantial burden of physical and psychological symptoms during treatment. Patients undergoing adjuvant chemotherapy often experience anxiety, fatigue, sleep disturbances and reduced quality of life, which may negatively affect treatment adherence and overall well-being. Addressing these multidimensional needs requires integrated, patient-centred supportive care approaches.

Music therapy (MT) is a clinical and evidence-based intervention delivered by trained therapists, using both active and receptive techniques to support psychological and emotional well-being. Previous studies have shown that MT may reduce anxiety and improve mood and quality of life in oncology settings. However, most available evidence is based on conventional group-level study designs, which do not adequately capture the variability in individual responses to the intervention.

N-of-1 trials represent an innovative methodological approach in which repeated treatment and control periods are compared within the same individual, allowing each patient to act as her own control. This design enables the evaluation of personalised treatment effects and intra-individual variability, which is particularly relevant for supportive care interventions such as music therapy.

This study is a multicentre, non-profit, interventional pilot study designed as a series of combined N-of-1 trials. A total of 24 patients with histologically confirmed breast cancer undergoing adjuvant chemotherapy will be recruited from two oncology centres in Italy. Participants will be randomly assigned to one of two intervention sequences, alternating periods with music therapy and periods without intervention according to a crossover design consisting of four consecutive phases (A-1, B-1, A-2, B-2), each lasting four weeks.

During intervention phases, participants will attend weekly group music therapy sessions lasting approximately 60 minutes. Sessions will include both receptive techniques (such as guided listening and music imagery) and active techniques (such as instrumental or vocal improvisation and songwriting). In addition, participants will receive personalised music playlists to be used between sessions.

Assessments will be conducted at baseline and at predefined follow-up time points throughout the study (T1, T2 and T3), as well as before and after MT sessions where applicable. Patient-reported outcome measures will include validated instruments assessing anxiety, depression, quality of life, emotional distress, symptom intensity and sleep quality.

The primary objective of the study is to assess the feasibility of conducting an N-of-1 trial design in this population, including recruitment, retention, data completeness and acceptability of the intervention. Secondary objectives include exploring changes in psychological and physical well-being and estimating intra- and inter-patient variability in treatment response.

As a pilot study, this trial is not powered to detect definitive treatment effects. The results will be used to inform the design, methodological assumptions and sample size calculation of future adequately powered studies evaluating the effectiveness of music therapy using personalised trial approaches.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy, 15121
        • Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo - Alessandria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group 1-Musictherapy A
Music therapy in phase A1 and B1, no music therapy in phase A2 and B2
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
Active Comparator: Group 2 -Musictherapy B
Music therapy in phase A2 and B2, no music therapy in phase A1 and B1
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
State-Trait Anxiety Inventory
Time Frame: Every single session : 5 minutes before and 10 minutes after
Level of anxiety ( score 20-80)
Every single session : 5 minutes before and 10 minutes after

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-Rating Depression Scale (SDS),
Time Frame: 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)
Level of depression . Score (0-15)
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)
Time Frame: 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)
Changing in perceived quality of life. Score (0-100)
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)
Time Frame: every single session: 5 minutes before and 10 minutes after.
Changing in level of emotions. Score (0-10)
every single session: 5 minutes before and 10 minutes after.
Visual Analogue Scale (VAS)
Time Frame: pre-post sessions
Level of pain
pre-post sessions
Pittsburgh Sleep Quality Index (PSQI).
Time Frame: 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)
Changing in quality of sleep. Score (0-21)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto di Studi Superiori Musicali (ISSM) Conservatorio Antonio Vivaldi di Alessandria

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Patrizia Santinon, MD, Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo - Alessandria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 11, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ConsAL - IMPACT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to the nature of the study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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