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

NCT05911269 | Active Not Recruiting

• 3 other identifiers: UMCC 2023.024HUM00231408R34CA286712
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Identification of facilitators and barriers to virtual TiMBRe participation

  up to 8 weeks post start of intervention

• Change in Anxiety management

  at baseline and eight weeks post initiation of treatment

Study Arms (2)

TiMBRe

EXPERIMENTAL

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

Attention-Control

ACTIVE COMPARATOR

Standard of care study staff calls and cancer survivorship resources

Other: Control

Interventions

TiMBRe OTHER

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.

TiMBRe

Control OTHER

Standard of care study staff calls and cancer survivorship resources

Attention-Control

Eligibility Criteria

• Age: 15 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48118, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Timbre Perception

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Auditory Perception; Vestibulocochlear Physiological Phenomena; Physiological Phenomena

Study Officials

• Robert Knoerl

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Explanatory-Sequential Mixed Methods Study

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 20, 2023
• Study Start: January 21, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)