Breast CancerIMPACT-NCT07549685
Music Therapy in Patients With Breast Cancer (IMPACT)
A study testing Music Therapy in people with Breast Cancer, run by Istituto di Studi Superiori Musicali (ISSM) Conservatorio Antonio Vivaldi di Alessandria at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Music Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 12 Nov 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo - Alessandria
Alessandria, 15121
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Music Therapy
- Keywords
- Medical Music Therapy, Quality of life, Anxiety, Distress, Pain, Cancer, Woman, Integrative
- Medical subject headings
- Breast Neoplasms, Anxiety Disorders, Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyOther
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 group | Role | What they receive |
|---|---|---|
| Group 1-Musictherapy A | Active comparator | Music therapy in phase A1 and B1, no music therapy in phase A2 and B2 Receives: Other: Music Therapy |
| Group 2 -Musictherapy B | Active comparator | Music therapy in phase A2 and B2, no music therapy in phase A1 and B1 Receives: Other: Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory
Level of anxiety ( score 20-80)
Measured: Every single session : 5 minutes before and 10 minutes after
Secondary outcomes (5)
Self-Rating Depression Scale (SDS),
Level of depression . Score (0-15)
Measured: 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)
Changing in perceived quality of life. Score (0-100)
Measured: 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)
Changing in level of emotions. Score (0-10)
Measured: every single session: 5 minutes before and 10 minutes after.
Visual Analogue Scale (VAS)
Level of pain
Measured: pre-post sessions
Pittsburgh Sleep Quality Index (PSQI).
Changing in quality of sleep. Score (0-21)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start12 Nov 2025
- Primary completion11 Mar 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto di Studi Superiori Musicali (ISSM) Conservatorio Antonio Vivaldi di Alessandria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrizia Santinon, MD, Principal investigator, Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo - Alessandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549685
- Sponsor's protocol ID
- ConsAL - IMPACT
- Acronym
- IMPACT-
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the nature of the study
Publications
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.
PubMed 38679306Palmer 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.
PubMed 26282640Bradt 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.
PubMed 25322972Bradt 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.
PubMed 34637527Bray 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.
PubMed 38572751Chang 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.
PubMed 39026220Giordano F, Baroni M, Zingarelli M, Scarlata E, Pelazza C, Mazzucco R, Santi M, Albini G, Visconti M, Rossi M, Blasi L, Santinon P. Feasibility of an N-of-1 trial using a crossover design to evaluate music therapy in patients with breast cancer undergoing adjuvant chemotherapy: a multicentre pilot study protocol in two Italian centres (IMPACT-CASTA DIVA). BMJ Open. 2026 Sep 15;16(9):e122143. doi: 10.1136/bmjopen-2026-122143.
PubMed 42744377
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07549685
- Acronym / sponsor ID
- IMPACT- / ConsAL - IMPACT
- Conditions
- Breast Cancer
- Keywords
- Medical Music Therapy, Quality of life, Anxiety, Distress, Pain, Cancer, Woman, Integrative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Istituto di Studi Superiori Musicali (ISSM) Conservatorio Antonio Vivaldi di AlessandriaUniversity, hospital or other
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1-Musictherapy A | Active comparator | Other: Music TherapyMusic therapy in phase A1 and B1, no music therapy in phase A2 and B2 |
| Group 2 -Musictherapy B | Active comparator | Other: Music TherapyMusic therapy in phase A2 and B2, no music therapy in phase A1 and B1 |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TherapyGroup 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 | Other | Group 1-Musictherapy A, Group 2 -Musictherapy B |
Primary outcome
State-Trait Anxiety Inventory
Time frame: Every single session : 5 minutes before and 10 minutes after
Level of anxiety ( score 20-80)
5 secondary outcomes
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)
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)
Emotion Thermometers (ET)
Time frame: every single session: 5 minutes before and 10 minutes after.
Visual Analogue Scale (VAS)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 38679306Giordano 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.
- Background: PubMed 26282640Palmer 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.
- Background: PubMed 25322972Bradt 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.
- Background: PubMed 34637527Bradt 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.
- Background: PubMed 38572751Bray 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.
- Background: PubMed 39026220Chang 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.
- Derived from this study: PubMed 42744377Giordano F, Baroni M, Zingarelli M, Scarlata E, Pelazza C, Mazzucco R, Santi M, Albini G, Visconti M, Rossi M, Blasi L, Santinon P. Feasibility of an N-of-1 trial using a crossover design to evaluate music therapy in patients with breast cancer undergoing adjuvant chemotherapy: a multicentre pilot study protocol in two Italian centres (IMPACT-CASTA DIVA). BMJ Open. 2026 Sep 15;16(9):e122143. doi: 10.1136/bmjopen-2026-122143.
- website of PNRR projectLink provided by the sponsor.
- Individual participant dataSharing planned: No. Due to the nature of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrizia Santinon, MD principal investigator
Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo - Alessandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Breast Cancer, run by Istituto di Studi Superiori Musicali (ISSM) Conservatorio Antonio Vivaldi di Alessandria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (time frame: Every single session : 5 minutes before and 10 minutes after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07549685, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.