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

Sponsor

University of Michigan Rogel Cancer Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05911269

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Other: TiMBRe Other: Control	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Explanatory-Sequential Mixed Methods StudyExplanatory-Sequential Mixed Methods Study

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2026

Anticipated Study Completion Date :

Aug 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TiMBRe 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 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.
Active Comparator: Attention-Control Standard of care study staff calls and cancer survivorship resources	Other: Control Standard of care study staff calls and cancer survivorship resources

Arm

Intervention/Treatment

Experimental: TiMBRe

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

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.

Active Comparator: Attention-Control

Standard of care study staff calls and cancer survivorship resources

Other: Control

Standard of care study staff calls and cancer survivorship resources

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Identification of facilitators and barriers to virtual TiMBRe participation [up to 8 weeks post start of intervention]
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.
Change in Anxiety management [at baseline and eight weeks post initiation of treatment]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 39 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48118

Sponsors and Collaborators

University of Michigan Rogel Cancer Center

Investigators

Principal Investigator: Robert Knoerl, University of Michigan Rogel Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Michigan Rogel Cancer Center

ClinicalTrials.gov Identifier:

NCT05911269

Other Study ID Numbers:

UMCC 2023.024
HUM00231408

First Posted:

Jun 20, 2023

Last Update Posted:

Jun 20, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Jun 20, 2023