Breast CarcinomaNCT06494046
Defining Musical Toxicity and Its Effect on Patient Well-being
An observational study of Breast Carcinoma and Esophageal Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This study evaluates the experience of musicians who are going through cancer treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma, Esophageal Carcinoma, Head and Neck Carcinoma
- What is being tested?
- Non-Interventional Study
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2024to 19 May 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are active or accomplished musicians undergoing cancer treatment.
Who may be able to join
- * Adults ≥ 18 years or older
- Active or accomplished musicians
- Those performing in the community as part of a group or as a soloist
- Those teaching lessons in an individual or group setting
- Those for whom music teaching or performance is a primary source of income
- Those who play music multiple times per week
Show all 16Show fewer
- Our ideal cohort will consist of an equal number of patients with the following malignancies above the diaphragm:
- Brain
- Head and Neck
- Esophagus or Lung
- Breast
- Our ideal cohort will consist of an equal number of patients who engage in the following musical endeavors:
- Stringed instruments
- Wind instruments (including woodwind and brass instruments)
- Keyboard instruments
- Vocalists
Who cannot join
- * < 18 years
- Did not regularly attempt to engage in musical endeavors during or after cancer treatment
- Not willing or able to complete the questionnaire or engage in a one-hour interview (i.e. limited English proficiency)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
This study evaluates the experience of musicians who are going through cancer treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- Describe specific musical difficulties that arise during and after cancer treatments: define "musical toxicity".
II. Discover any interventions or treatments which musicians found helpful while going through cancer treatment.
III. Investigate whether the priority of playing music changed through the course of cancer treatment and beyond, in relation to other priorities including cancer cure and length of life.
IV. Discover treatment and cancer related factors which are correlated with worse musical toxicity.
OUTLINE: This is an observational study. Patients are assigned to 1 of 2 groups.
MUSICAL TOXICITY GROUP: Patients complete a questionnaire, participate in an interview and have their medical records reviewed on study.
NO MUSICAL TOXICITY GROUP: Patients have their medical records reviewed on study.
- Conditions
- Breast Carcinoma, Esophageal Carcinoma, Head and Neck Carcinoma, Lung Carcinoma, Malignant Brain Neoplasm, Malignant Solid Neoplasm
- Being tested
- Non-Interventional Study
- Medical subject headings
- Breast Neoplasms, Esophageal Neoplasms, Lung Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-Interventional Study
| Study group | Role | What they receive |
|---|---|---|
| Observational Musical Toxicity Group | Patients complete a questionnaire, participate in an interview and their medical records reviewed on study. Receives: Other: Non-Interventional Study | |
| Observational No Musical Toxicity Group | Patients have their medical records reviewed on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe specific musical difficulties that arise during and after cancer treatments - MTQ 10-item
Assessed using the Musical Toxicity Questionnaire (MTQ 10-item), a survey with yes/no and open-ended questions (e.g., What musical instrument do you play, or do you sing?). The survey is designed to capture the participant's thoughts and feelings on how cancer treatments (before and after) has affected enjoyment and ability to play, teach, or perform music. The questionnaire will take about 15-30 minutes to complete. Qualitative analysis software will be utilized to code responses and organize themes. Themes will be organized into related groups and interpreted to generate conclusions.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start15 Aug 2024
- Primary completion19 May 2025
- Study completion19 May 2025
Why it stopped: Resident working with study left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dean A. Shumway, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494046
- Sponsor's protocol ID
- ROR2333
- Other IDs
- NCI-2024-05423, 23-012760, ROR2333
- Status last verified
- May 2025
- First submitted
- 2 Jul 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Musical Toxicity and Its Effect on Patient Well-being
- ClinicalTrials.gov ID
- NCT06494046
- Acronym / sponsor ID
- ROR2333
- Conditions
- Breast Carcinoma, Esophageal Carcinoma, Head and Neck Carcinoma, Lung Carcinoma, Malignant Brain Neoplasm, Malignant Solid Neoplasm
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Resident working with study left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- 19 May 2025 (actual)
- First posted
- 10 Jul 2024 (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 evaluates the experience of musicians who are going through cancer treatment.
Detailed description
PRIMARY OBJECTIVES:
- Describe specific musical difficulties that arise during and after cancer treatments: define "musical toxicity".
II. Discover any interventions or treatments which musicians found helpful while going through cancer treatment.
III. Investigate whether the priority of playing music changed through the course of cancer treatment and beyond, in relation to other priorities including cancer cure and length of life.
IV. Discover treatment and cancer related factors which are correlated with worse musical toxicity.
OUTLINE: This is an observational study. Patients are assigned to 1 of 2 groups.
MUSICAL TOXICITY GROUP: Patients complete a questionnaire, participate in an interview and have their medical records reviewed on study.
NO MUSICAL TOXICITY GROUP: Patients have their medical records reviewed on study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational Musical Toxicity Group | – | Other: Non-Interventional StudyPatients complete a questionnaire, participate in an interview and their medical records reviewed on study. |
| Observational No Musical Toxicity Group | – | Other: Non-Interventional StudyPatients have their medical records reviewed on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are active or accomplished musicians undergoing cancer treatment.
Key inclusion criteria (16 listed)
- * Adults ≥ 18 years or older
Key exclusion criteria (3 listed)
- * < 18 years
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 |
|---|---|---|
| Non-Interventional StudyNon-Interventional Study | Other | Observational Musical Toxicity Group, Observational No Musical Toxicity Group |
Primary outcome
Describe specific musical difficulties that arise during and after cancer treatments - MTQ 10-item
Time frame: Baseline
Assessed using the Musical Toxicity Questionnaire (MTQ 10-item), a survey with yes/no and open-ended questions (e.g., What musical instrument do you play, or do you sing?). The survey is designed to capture the participant's thoughts and feelings on how cancer treatments (before and after) has affected enjoyment and ability to play, teach, or perform music. The questionnaire will take about 15-30 minutes to complete. Qualitative analysis software will be utilized to code responses and organize themes. Themes will be organized into related groups and interpreted to generate conclusions.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Dean A. Shumway, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma and Esophageal Carcinoma, run by Mayo Clinic at 1 site in United States.
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 16 inclusion and 3 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: withdrawn, as of the sponsor's last update on 4 Jun 2025. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Describe specific musical difficulties that arise during and after cancer treatments - MTQ 10-item (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2025.