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NCT Number: NCT05911269

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

15 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Control

Other

Standard of care study staff calls and cancer survivorship resources

Primary outcomes

  1. Acceptability of TiMBRe

    Time frame: up to 8 weeks post start of intervention

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

  2. Demand of TiMBRe

    Time frame: up to 3 years from start of study

    percent of patients recruited over three years

  3. Adherence to TiMBRe

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

    percent of TiMBRe participants to complete the baseline and 8 weeks patient report measures

  4. Practicality of TiMBRe

    Time frame: 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 outcomes

  1. Identification of facilitators and barriers to virtual TiMBRe participation

    Time frame: 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.

  2. Change in Anxiety management

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 20, 2023
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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