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

University of Michigan Rogel Cancer Center50 enrolled

Overview

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.

Initially Sessions 7 and 8 were both body percussion; however, the 04FEB2025 changed this to Session 7 will be body percussion and session 8 will be selected by the participant. This will allow for more tailoring of the intervention.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Anxiety

Interventions

TiMBReOTHER

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 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. 8 Participants Choice * will be selected by the participant.

ControlOTHER

Standard of care study staff calls and cancer survivorship resources

Eligibility

Sex: ALLMin age: 15 YearsMax age: 39 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Acceptability of TiMBRe

mean scores for the Acceptability E-scale Items are ≥ 4/5

Time frame: up to 8 weeks post start of intervention

Demand of TiMBRe

percent of patients recruited over three years

Time frame: 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

Time frame: 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

Time frame: From enrollment to end of treatment at 8 weeks

Secondary Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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