Ignite Creation Date:
2024-05-06 @ 6:01 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05519488
Status:
RECRUITING
Last Update Posted:
2022-12-09
First Post:
2022-08-25
Brief Title:
Evaluation of an Algorithmically Enhanced Personalized Music-based Intervention on Stress Reduction in Cancer Patients
Sponsor:
Rubato Life
Organization:
Rubato Life
Study Overview
Official Title:
Evaluation of an Algorithmically Enhanced Personalized Music-based Intervention on Stress Reduction in Cancer Patients
Status:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Elizabeths 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
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 Elizabeths 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 AimsObjectives
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 R61R33 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 Theres 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 patients 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 11 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 InclusionExclusion 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 11 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 OutcomesEndpoints
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 086 -095 and test-retest reliability from 065-075
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 happenedhappening 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 005 power of 080 with a proportion of subjects from each group of 05 with and Standardized effect size of 0400
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
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 R61R33 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 Theres 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 patients 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 11 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 InclusionExclusion 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 11 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 OutcomesEndpoints
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 086 -095 and test-retest reliability from 065-075
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 happenedhappening 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 005 power of 080 with a proportion of subjects from each group of 05 with and Standardized effect size of 0400
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None