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

NCT ID: NCT05911269

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-21
• Study Completion Date: 2030-06-30

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.

Detailed Description

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

TiMBRe

Intervention Type: 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.

Attention-Control

Standard of care study staff calls and cancer survivorship resources

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

Standard of care study staff calls and cancer survivorship resources

Interventions

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 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.

Intervention Type: OTHER

Control

Standard of care study staff calls and cancer survivorship resources

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Knoerl

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Robert Knoerl

Role: CONTACT

rjknoerl@med.umich.edu

734-764-8617

Facility Contacts

Robert Knoerl

Role: primary

rjknoerl@med.umich.edu

734-764-8617

Other Identifiers

HUM00231408

Identifier Type: OTHER

Identifier Source: secondary_id

R34CA286712

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UMCC 2023.024

Identifier Type: -

Identifier Source: org_study_id