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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05911269
• Other study ID #: UMCC 2023.024
• Secondary ID: HUM00231408
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: September 2028

Study information

• Verified date: April 2024
• Source: University of Michigan Rogel Cancer Center
• Contact: Robert Knoerl
• Phone: 734-764-8617
• Email: rjknoerl[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2028
• Est. primary completion date: September 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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.
• Control
Standard of care study staff calls and cancer survivorship resources

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of TiMBRe	mean scores for the Acceptability E-scale Items are = 4/5	up to 8 weeks post start of intervention
Primary	Demand of TiMBRe	percent of patients recruited over three years	up to 3 years from start of study
Primary	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
Primary	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	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.	up to 8 weeks post start of intervention
Secondary	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.	at baseline and eight weeks post initiation of treatment