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

NCT05519488 | Unknown

• 1 other identifier: RLM1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cancer; Stress

Keywords

Music; Stress; Cancer; Anxiety; Rubato

Outcome Measures

Primary Outcomes (1)

• State-Anxiety (STAI-S)

  A standardized 20-item assessment of state-level (momentary, situational) anxiety (Spielberger et al., 1999). Example items include "I am tense", "I am worried" and "I feel calm", "I feel secure". STAI has an internal consistency ranging between 0.86 -0.95 and test-retest reliability from 0.65-0.75.

  2 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: Rubato Life Music

Control group

ACTIVE COMPARATOR

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

Behavioral: Music of their desire

Interventions

Rubato Life Music BEHAVIORAL

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

Intervention group

Music of their desire BEHAVIORAL

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)

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rubato Life: lead

Study Sites (1)

Saint Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

RECRUITING

Related Publications (8)

• Boyde C, Linden U, Boehm K, Ostermann T. The Use of Music Therapy During the Treatment of Cancer Patients: A Collection of Evidence. Glob Adv Health Med. 2012 Nov;1(5):24-9. doi: 10.7453/gahmj.2012.1.5.009. Epub 2012 Nov 1.

  PMID: 27257528 BACKGROUND

• Bradt J, Potvin N, Kesslick A, Shim M, Radl D, Schriver E, Gracely EJ, Komarnicky-Kocher LT. The impact of music therapy versus music medicine on psychological outcomes and pain in cancer patients: a mixed methods study. Support Care Cancer. 2015 May;23(5):1261-71. doi: 10.1007/s00520-014-2478-7. Epub 2014 Oct 17.

  PMID: 25322972 BACKGROUND

• Burns DS, Sledge RB, Fuller LA, Daggy JK, Monahan PO. Cancer patients' interest and preferences for music therapy. J Music Ther. 2005 Fall;42(3):185-99. doi: 10.1093/jmt/42.3.185.

  PMID: 16086604 BACKGROUND

• Gramaglia C, Gambaro E, Vecchi C, Licandro D, Raina G, Pisani C, Burgio V, Farruggio S, Rolla R, Deantonio L, Grossini E, Krengli M, Zeppegno P. Outcomes of music therapy interventions in cancer patients-A review of the literature. Crit Rev Oncol Hematol. 2019 Jun;138:241-254. doi: 10.1016/j.critrevonc.2019.04.004. Epub 2019 Apr 5.

  PMID: 31121392 BACKGROUND

• Jasemi M, Aazami S, Zabihi RE. The Effects of Music Therapy on Anxiety and Depression of Cancer Patients. Indian J Palliat Care. 2016 Oct-Dec;22(4):455-458. doi: 10.4103/0973-1075.191823.

  PMID: 27803568 BACKGROUND

• Sihvonen AJ, Sarkamo T, Leo V, Tervaniemi M, Altenmuller E, Soinila S. Music-based interventions in neurological rehabilitation. Lancet Neurol. 2017 Aug;16(8):648-660. doi: 10.1016/S1474-4422(17)30168-0. Epub 2017 Jun 26.

  PMID: 28663005 BACKGROUND

• Stanczyk MM. Music therapy in supportive cancer care. Rep Pract Oncol Radiother. 2011 Jun 8;16(5):170-2. doi: 10.1016/j.rpor.2011.04.005.

  PMID: 24376975 BACKGROUND

• Yamasaki A, Mise Y, Mise Y, Lee JE, Aloia TA, Katz MH, Chang GJ, Lillemoe KD, Raut CP, Conrad C. Musical preference correlates closely to professional roles and specialties in operating room: A multicenter cross-sectional cohort study with 672 participants. Surgery. 2016 May;159(5):1260-8. doi: 10.1016/j.surg.2015.10.031. Epub 2015 Dec 23.

  PMID: 26706609 BACKGROUND

Related Links

• Rubato is an innovative technology that matches music to the listener's physiological and psychological state.

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Claudius Conrad, MD,PhD,FACS

  Saint Elizabeth's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar Salirrosas, MD FACS

CONTACT

6179914279; claudius.conrad@steward.org

Amit Sternberg

CONTACT

4242058386; amits@rubato.life

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 29, 2022
• Study Start: December 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)