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Trial Title:
Feasibility of Virtual, Tailored, Music-Based Relaxation for Anxiety in Adolescent and Young Adult Cancer Survivors
NCT ID:
NCT05911269
Condition:
Anxiety
Conditions: Official terms:
Anxiety Disorders
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Explanatory-Sequential Mixed Methods Study
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
TiMBRe
Description:
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.
Arm group label:
TiMBRe
Intervention type:
Other
Intervention name:
Control
Description:
Standard of care study staff calls and cancer survivorship resources
Arm group label:
Attention-Control
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.
Criteria for 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.
Gender:
All
Minimum age:
15 Years
Maximum age:
39 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Michigan
Address:
City:
Ann Arbor
Zip:
48118
Country:
United States
Contact:
Last name:
Robert Knoerl
Phone:
734-764-8617
Email:
rjknoerl@med.umich.edu
Investigator:
Last name:
Robert Knoerl
Email:
Principal Investigator
Start date:
December 2024
Completion date:
February 2029
Lead sponsor:
Agency:
University of Michigan Rogel Cancer Center
Agency class:
Other
Source:
University of Michigan Rogel Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05911269
