Trial Title:
Evaluation of an Algorithmically Enhanced Personalized Music-based Intervention on Stress Reduction in Cancer Patients
NCT ID:
NCT05519488
Condition:
Cancer
Stress
Conditions: Keywords:
Music
Stress
Cancer
Anxiety
Rubato
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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.
Primary purpose:
Supportive Care
Masking:
Double (Participant, Care Provider)
Intervention:
Intervention type:
Behavioral
Intervention name:
Rubato Life Music
Description:
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
Arm group label:
Intervention group
Intervention type:
Behavioral
Intervention name:
Music of their desire
Description:
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)
Arm group label:
Control group
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.
Detailed description:
A. Specific Aims/Objectives:
• Primary Aim:
Determine if Rubato Life (RL) music selection is effective at reducing anxiety (STAI-S)
in cancer patients undergoing restaging.
B. Background and Significance
The field of music-based interventions (MBI) is growing rapidly as part of the treatment
of patients with chronic diseases such as schizophrenia, cardiovascular disease,
dementia, chronic pain and cancer (Sihvonen et al., 2017). MBI can be divided into Music
Therapy (MT) and Music Medicine (MM).
In MT, patients are guided through a music intervention by trained music therapist. In
MM, patients listen to live or recorded music, or participate in other music
interventions without the personalized care of a music therapist (Stanczyk et al., 2011).
Music listening has been shown to reduce anxiety, and lower blood pressure (Panteleeva et
al., 2018), as well as help patients cope with negative emotions (Miranda and Claes,
2009). Previous studies have shown that MBI in the form of MM is a valuable addition to
the treatments of patients diagnosed with cancer by improving outcomes and helping
patients cope with the mental and emotional strain that accompanies their disease (Bradt
et al., 2015; Gramaglia et al., 2019; Jasemi et al., 2016). Other studies also found that
there is a growing interest in MBI among patients with cancer (Burns et al., 2005).
Nonetheless, traditional MM compared to effective MT lacks the personalization and
moment-to-moment adjustments that accompany music therapy in the hands of a seasoned
professional. There are adverse effects of music, such as increases in stress that can
accompany listening to music that one finds aversive, which music therapists can
mitigate. There is a need for a similar approach in MM, especially when limitations make
the presence of a music therapist impractical.
There is also more work to be done to separate more and less effective MM interventions.
Recognizing the need for a better understanding of the role of music in clinical
medicine, the NIH has reissued RFA-AT-19-001 (Promoting Research on Music and Health:
Phased Innovation Award for Music Interventions (R61/R33, Clinical Trial Optional). This
signifies a recognition of the need for a better understanding of music in the clinical
setting.
One aspect of MBI that has not been extensively investigated in prior studies involving
MM is the selection of music patients listen to. Often, patients are not asked regarding
their preferred musical genres and the musical taste or opinion of an experimenter or
medical provider is used to select the music. Alternatively, the patient is asked to list
their music preferences and a single individualized playlist is created, which is time
consuming and may induce stress (Stanczyk et al., 2011). There's also evidence that a
single playlist, when repeated too many times, can lose its power to reduce stress.
Despite the proven effectiveness of music-induced relaxation, making a music intervention
patient-specific has significant challenges: the cost associated with a professional
music therapist or personalized music curator operator dependence, lack of
reproducibility, and lack of increasing effectiveness. This leads to MBI not being widely
practiced. Rubato Life™ (RL) provides a low cost and effective MBI using a proprietary
algorithm for music selection that improves with feedback from a patient's physiological
responses. More specifically, machine-learning and deep neural network learning are
applied to select music that is reduces stress as measured by heart rate variability in
real time. Additionally, demographic information from prior published studies (Yamasaki
et al., 2016) and unpublished work is used to further improve of music selection, and the
curation of patient-specific playlists.
This study aims to determine the effect of the RL music selection algorithm on cancer
patients' physiological and psychological state during re-staging appointments. In this
change from baseline study design, we will examine the stress and anxiety levels of
patients during restaging appointments to determine the ability of RL decrease state
anxiety of individual patients undergoing cancer restaging. Further, we will compare this
change to that of a group of patients who undergo MBI based on commercially available
music selection (chosen by participants) that does not use individual heart rate
variability measures in real time.
D. Design and Methodology:
1) Study Design
200 adult patients with cancer undergoing restaging will be enrolled. Participants will
be recruited during their appointments for cancer restaging
The Primary Surgical Attending, will approach the patients at first, and a deeper
explanation of the Study will be given to patients by the Study Coordinator.
An interim analysis will be performed after the first 30 patients' complete participation
Enrolled patients will submit demographic, socioeconomic and medical information, initial
music preference, and will complete a standardized stress and anxiety questionnaire to
establish baseline stress and anxiety levels.
Patients will then be randomized 1:1 into 2 groups: (a) the intervention group in which
patients will be asked to listen to a minimum of 45 minutes per day of music for a period
of a 2 weeks (or a total of 12 hours) coming up to their scheduled appointment using the
RL music selection application while wearing an individual smart bracelet aimed to build
their optimal music therapy profile; and (b) the control group in which 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 the same time
period.
On the day of their restaging appointments, patients from both groups will be asked to
complete a baseline STAI-S stress and anxiety questionnaire followed by either one hour
of RL selected music in the intervention group or patient selected music for the control
group. At completion of one hour of listening, another STAI-S will be completed to assess
change in stress levels thereby allowing for a change from baseline levels of stress and
anxiety.
2) Inclusion/Exclusion Criteria
Inclusion criteria:
1. Aged 18 or older
2. Diagnosed with cancer, requiring restaging imaging between September 2022 and May
2023,
3. Have access to a smartphone and able to operate smartphone
4. Have a Google or Apple ID.
Exclusion criteria:
1. Participants with hearing disorders who do not use hearing aids
2. Participants who have extreme dislike of music.
3. Participants who cannot comply with the minimum time Rubato Life application
requires to be used
No subjects in this study require special consideration
3) Description of Study Treatments or Exposures
Participants will be randomly assigned (1:1) to be in either the Intervention or Control
group. The Intervention group will be given a smartwatch, the Rubato Life App downloaded
to their smartphone, and a Spotify acocunt. The Control group will be given a Spotify
account. Participants in both groups will be asked to listen to at least 45 minutes of
music per day (or a total of 12 hours) for 2 weeks prior to their restaging visit. Music
for the Control group will be participant-selected, at their leisure. Music for the
Intervention group will be a personalized playlist distributed to the participant through
the Rubato Life application. All participants will be asked to listen to music for one
hour immediately following the restaging appointment.
4) Definition of Primary and Secondary Outcomes/Endpoints
Primary outcome: Anxiety, as measured through the State-Trait Anxiety Inventory, State
component (STAI-S). Participants will be asked to complete the STAI-S prior to
randomization, the day of their restaging appointment, and one hour after their restaging
appointment.
5) Data Collection Methods, Assessments, Interventions and Schedule
Demographic questionnaire: A questionnaire for recording participants' age, race, patient
race, age, sex, income (range options), insurance status, music background, English
proficiency (range options), medications.
Brief Music Experience Questionnaire (BMEQ): A validated questionnaire to assess general
music preferences (Werner et al., 2006).
State-Trait Anxiety Inventory- State (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.
6) Confidentiality: Participant privacy and confidentiality will be maintained by
coding all data upon enrollment.
The research data will be destroyed in 5 years.
7) Adverse Event Criteria and Reporting Procedures: There are not adverse event
considered in listenint to music.
8) Study Timeline:
Rolling recruitment will take place upon study approval and will continue until 200
participants are enrolled.
E. Risks and Discomforts:
Participants may feel uncomfortable will answering certain questions about their current
anxiety. Participants may experience discomfort from wearing a smartwatch.
To minimize effects of risks, participants may skip questions that make them feel
uncomfortable.
Participants may contact study coordinator if discomfort arises from wearing smartwatch
and measures to reduce discomfort will be taken, such as loosening the watch.
Participants will be asked to report any other anxiety provoking events that
happened/happening during the study period.
Participants may discontinue participation at any time.
F. Potential Benefits:
There are no direct benefits to participants for participating in this study.
Participation in this study may benefit society by helping scientists understand how
music impacts anxiety associated with cancer restaging. The benefits to society outweigh
potential risks associated with this study.
G. Data Management, Recordkeeping and Analysis
1. Data Management Methods:
Data will be managed by the study coordinator, using Flask Data Manager, which is an
electronic recordkeeping program. The data will be coded upon enrollment and
connections from codes to identifiers will be stored in a password protected file
separate from the data. Data monitoring will be performed by the study coordinator
and the PI.
2. Quality Control Methods:
Only previously-validated assessments are used in this study, which have high
reliability and validity. All study members will be trained on appropriate study
protocols and responsible conduct of research. Study progress will be monitored
after collection of 30 participants with an interim analysis.
3. Data Analysis Plan:
Categorical variables will be compared using the Chi-square test. Continuous
variables will be compared using the Mann-Whitney U test and expressed as median
values (range), with scores grouped into 10-point ranges (0-9, 10-19, 20-29, etc).
Data will be analyzed after collection of 30 participants and at the conclusion of
the study, after all participant data has been collected.
4. Statistical Power and Sample Considerations:
The sample size will be set at a significance level of 0.05, power of 0.80, with a
proportion of subjects from each group of 0.5 with and Standardized effect size of 0.400.
Total sample size will be of 200 subjects, 100 in the Intervention group, and 100 in the
control group.
H. Study Organization:
This study will be overseen by Dr. Conrad, while daily research activities will be
completed primarily by the Study Coordinator.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Saint Elizabeth's Medical Center
Address:
City:
Boston
Zip:
02135
Country:
United States
Status:
Recruiting
Contact:
Last name:
Oscar Salirrosas, MD, FACS
Phone:
617-991-4279
Email:
oscarsr1508@gmail.com
Contact backup:
Last name:
Claudius Conrad, MD,PhD,FACS
Phone:
6177892442
Email:
claudius.conrad@steward.org
Investigator:
Last name:
Claudius Conrad, MD,PhD,FACS
Email:
Principal Investigator
Investigator:
Last name:
Oscar Salirrosas Roncal, MD, FACS
Email:
Sub-Investigator
Investigator:
Last name:
Eduardo A Vega, MD
Email:
Sub-Investigator
Investigator:
Last name:
William Kawahara
Email:
Sub-Investigator
Start date:
December 1, 2022
Completion date:
September 1, 2024
Lead sponsor:
Agency:
Rubato Life
Agency class:
Other
Source:
Rubato Life
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05519488
https://www.rubato.life/
