NCT05519488

Evaluation of an Algorithmically Enhanced Personalized Music-based Intervention on Stress Reduction in Cancer Patients

Status unknown NA Last updated 9 December 2022

What this trial tests

NA trial testing Rubato Life Music in Cancer in 200 participants. Status unknown.

Timeline

1 December 2022

Primary endpoint
1 September 2023

1 September 2024

Quick facts

Lead sponsor	Rubato Life
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	200
Start date	1 December 2022
Primary completion	1 September 2023
Estimated completion	1 September 2024
Sites	1 location across United States

Drugs / interventions tested

• Rubato Life Music
• Music of their desire

Conditions studied

• Cancer — all drugs for Cancer →
• Stress — all drugs for Stress →

Sponsor

Rubato Life

Who can join

18 and older, any sex, with Cancer or Stress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Receiving a cancer diagnosis is a life-altering event for patients and their families that not only carries serious physical health implications but also causes significant stress and emotional distress.

After initial diagnosis, restaging appointments can bring back additional fear, sadness, and anxiety. Music listening interventions can alleviate stress associated with cancer diagnosis by improving patients' ability to cope with the mental and emotional strain that accompanies their disease. Yet, current music listening interventions lack personalization and moment-to-moment adjustments that accompany traditional music therapy in the hands of a seasoned professional. Rubato Life™ (RL) application uses a proprietary algorithm for music selection that utilizes machine-learning and deep neural network to select music that reduces stress as measured by heart rate variability in real time, offering improved personalization of stress-reducing music. We hypothesize that using personalized musical playlists, through RL, will improve stress and anxiety outcomes for patients undergoing cancer restaging more than participant-selected music.

This 3-week longitudinal study will include 200 patients from St. Elizabeth's Medical Center who have scheduled appointments for cancer restaging. Participants will be randomized into one of two groups: a) an intervention group, in which patients will listen to music using Rubato Life app, and b) a control group, in which patients listen to music of their own choice that they believe to be stress reducing. Patients in both groups will be asked to listen to 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. Patients will be asked to complete assessments of anxiety (STAI-S) prior to randomization, on the day of their restaging, and following one hour of post-restaging music listening.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.