Recruiting

Personalized Music Intervention

Sponsor:

Rubato Life

Code:

NCT05519488

Conditions

Cancer

Stress

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rubato Life Music

Music of their desire

Study Details

Brief summary:

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 Lifeā„¢ (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.

Conditions

Cancer

Stress

Study ID

NCT05519488

Start date

Dec 1, 2022

Status verified date

Dec, 2022

Completion date

Sep 1, 2024

Anticipated

Primary completion date

Sep 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Aged 18 or older
  • Diagnosed with cancer, requiring restaging imaging between September 2022 and May 2023,
  • Have access to a smartphone and able to operate smartphone
  • Have a Google or Apple ID.

Exclusion Criteria:

  • Participants with hearing disorders who do not use hearing aids
  • Participants who have extreme dislike of music.
  • Participants who cannot comply with the minimum time Rubato Life application requires to be used

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention group

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

active comparator: Control group

Patients who have scheduled appointments for cancer restaging. Participants will listen to music of their own choice that they believe to be stress reducing

Interventions

Rubato Life Music

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

Music of their desire

patients will be asked to listen to a minimum of 45 minutes per day of music (or a total of 12 hours), of their desire, which the participant considers as stress relief music for a period of a 2 weeks (or a total of 12 hours)

Primary outcome measure

  • State-Anxiety (STAI-S) [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Locations

Saint Elizabeth's Medical Center

Recruiting

Boston, Massachusetts, United States, 02135

Contacts

Oscar Salirrosas, MD, FACS

617-991-4279oscarsr1508@gmail.com

Claudius Conrad, MD,PhD,FACS

6177892442claudius.conrad@steward.org

Principal Investigator:

Claudius Conrad, MD,PhD,FACS

More Information

Sponsor

Rubato Life

Last update posted

Dec 9, 2022

Last verified

Dec, 2022

Keywords

  • Music
  • Stress
  • Cancer
  • Anxiety
  • Rubato

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rubato Life on 2022-12-09.