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Personalized Music-based Intervention for Stress in Cancer Patients
N/A
Recruiting
Led By Claudius Conrad, MD,PhD,FACS
Research Sponsored by Rubato Life
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
Study Summary
This trial will test whether using a personalized music playlist, through the Rubato Life app, can reduce stress and anxiety for cancer patients more than music of the patient's own choice.
Who is the study for?
This trial is for adults over 18 with a cancer diagnosis who need restaging imaging, can use a smartphone, and have a Google or Apple ID. It's not for those with hearing issues (unless they use aids), people who really dislike music, or anyone unable to commit to the app's minimum usage time.Check my eligibility
What is being tested?
The study tests if personalized music from the Rubato Life app reduces stress better than self-chosen music in cancer patients awaiting restaging. Participants will listen daily and wear smartwatches to monitor stress levels via heart rate variability.See study design
What are the potential side effects?
Since this trial involves listening to music, there are no direct medical side effects expected. However, participants may experience emotional responses related to their personal reactions to the music.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
State-Anxiety (STAI-S)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment1 Intervention
Patients who have scheduled appointments for cancer restaging. Participants will listen to music using Rubato Life app at least 45 minutes per day, for a period of 2 weeks coming up to their scheduled restaging appointment (or at least 12 total hours of listening), and for one hour immediately after the appointment. Patients in the Intervention group will wear smartwatches to monitor heart rate variability throughout the study
Group II: Control groupActive Control1 Intervention
Patients who have scheduled appointments for cancer restaging. Participants will listen to music of their own choice that they believe to be stress reducing
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Who is running the clinical trial?
Rubato LifeLead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
Claudius Conrad, MD,PhD,FACSPrincipal InvestigatorSaint Elizabeth's Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I need new scans for my cancer between September 2022 and May 2023.I am 18 years old or older.I strongly dislike music.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention group
- Group 2: Control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to volunteer for this clinical research?
"According to the information posted on clinicaltrials.gov, this research project is not currently recruiting volunteers. The trial was initially published on September 1st 2022 and has been unaltered since then. While there are no spots available for this study presently, 627 other trials have vacancies open at present."
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