Feasibility of Virtual, Tailored, Music-Based Relaxation for Anxiety in Adolescent and Young Adult Cancer Survivors

Study Overview
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Brief Summary
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Demonstrate the feasibility of conducting an eight-week, (45 min/week), theory driven, virtually-delivered, tailored music-based relaxation (TiMBRe) intervention to decrease anxiety in adolescent and young adult (AYA) cancer survivors with clinically-relevant anxiety.

Official Title
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Determining the Feasibility of Virtual, Tailored, Music-Based Relaxation for Anxiety in Adolescent and Young Adult Cancer Survivors

Conditions
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Anxiety

Intervention / Treatment
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* Other: TiMBRe
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 15 - 39 years old at least one month post cancer treatment report clinically relevant anxiety in the past seven days (PROMIS Anxiety 4a scores ≥ 55)35 speak/read English. Exclusion Criteria: prognosis less than 3 months documentation of significant hearing impairment plan to receive surgery, radiation, or chemotherapy for cancer treatment during the study period plans in place to begin new psychosocial (i.e., cognitive behavioral therapy14 or mindfulness-based stress reduction15) or pharmacological treatments for anxiety during the study. Although, participants may continue psychosocial or pharmacological treatments for anxiety if the treatments were initiated at least eight weeks prior to study enrollment, the dose has not changed, and they report clinically relevant anxiety in the last week.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Explanatory-Sequential Mixed Methods Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TiMBRe<br>an eight-week, (45 min/week), theory driven, virtually-delivered, tailored music-based relaxation (TiMBRe) intervention to decrease anxiety in AYA cancer survivors with clinically-relevant anxiety. | Other: TiMBRe<br>* 1 & 2 Music Listening Live music played by the music therapist (e.g., guitar, voice) and AYA selected music will be used to facilitate attention to the present moment and provide cues for breathing/relaxation. 3 & 4 Music Facilitated Breathing The therapist will lead participants in music facilitated breathing exercises using rhythmic features of the music to cue structured breathing for relaxation and self-awareness 5 & 6 Music Facilitated Progressive Muscle Relaxation for Stress Reduction Using music as a structured auditory cue for tensing and releasing of muscles. 7 & 8 Body Percussion The therapist will lead participants in a hands-on body percussion activity to bring attention to the sound of rhythm, sensation in their hands and body.<br>|
| Active Comparator: Attention-Control<br>Standard of care study staff calls and cancer survivorship resources | Other: Control<br>* Standard of care study staff calls and cancer survivorship resources<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of TiMBRe | mean scores for the Acceptability E-scale Items are ≥ 4/5 | up to 8 weeks post start of intervention | 
| Demand of TiMBRe | percent of patients recruited over three years | up to 3 years from start of study | 
| Adherence to TiMBRe | percent of TiMBRe participants to complete the baseline and 8 weeks patient report measures | From enrollment to end of treatment at 8 weeks | 
| Practicality of TiMBRe | percent of TiMBRe group participants self-report practicing music-based relaxation skills for at least 10 minutes on at least three days per week | From enrollment to end of treatment at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of facilitators and barriers to virtual TiMBRe participation | Interviews will be transcribed by a professional HIPAA compliant transcription agency. We will analyze interview data using inductive content analysis.74 Transcripts will be entered into NVivo Qualitative Data Analysis Software (QSR International, Melbourne, Australia). The study team will read transcripts to derive codes, discuss labels to group codes into categories, and identify major themes and corresponding exemplar quotes. The interviewer will write reflexive memos after each interview and review memos with corresponding audio recordings to discern linkages, gaps, and questions. | up to 8 weeks post start of intervention | 
| Change in Anxiety management | determine the preliminary impact of the eight-week virtual TiMBRe intervention, relative to the control, on improving anxiety (PROMIS Anxiety 4a, 40.3 - 81.6; higher scores = worse anxiety) utilizing data collected at baseline, four weeks, and eight weeks. Reporting the change from baseline to eight weeks. | at baseline and eight weeks post initiation of treatment |