Clinical trial · Interventional
Evaluation of an Algorithmically Enhanced Personalized Music-based Intervention on Stress Reduction in Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Stress | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Music of their desire | Behavioral | — | UNRESOLVED |
| Rubato Life Music | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- 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
- interventionNames
- Behavioral: Rubato Life Music
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Patients who have scheduled appointments for cancer restaging. Participants will listen to music of their own choice that they believe to be stress reducing
- interventionNames
- Behavioral: Music of their desire
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDBoyde 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
- BACKGROUNDBradt 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
- BACKGROUNDBurns 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
- BACKGROUNDGramaglia 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
- BACKGROUNDJasemi 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
- BACKGROUNDSihvonen 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
- BACKGROUNDStanczyk 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.