- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06494046
Defining Musical Toxicity and Its Effect on Patient Well-being
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. 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 Type
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
* 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
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
Exclusion Criteria:
* < 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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational Musical Toxicity Group
Patients complete a questionnaire, participate in an interview and their medical records reviewed on study.
|
Non-Interventional Study
|
|
Observational No Musical Toxicity Group
Patients have their medical records reviewed on study.
|
Non-Interventional Study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dean A. Shumway, M.D., Mayo Clinic in Rochester
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Site
- Neoplasms by Histologic Type
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Neoplasms, Glandular and Epithelial
- Esophageal Diseases
- Skin Diseases
- Breast Diseases
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Neoplasms
- Carcinoma
- Esophageal Neoplasms
- Breast Neoplasms
- Brain Neoplasms
Other Study ID Numbers
- ROR2333 (Other Identifier: Mayo Clinic in Rochester)
- NCI-2024-05423 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 23-012760 (Other Identifier: Mayo Clinic Institutional Review Board)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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