Anxiety
Conditions
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.
Interventions
OTHERTiMBRe
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.
OTHERControl
Standard of care study staff calls and cancer survivorship resources
Sponsors
University of Michigan Rogel Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Explanatory-Sequential Mixed Methods Study
Eligibility
Sex/Gender
ALL
Age
15 Years to 39 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of TiMBRe | up to 8 weeks post start of intervention | mean scores for the Acceptability E-scale Items are ≥ 4/5 |
| Demand of TiMBRe | up to 3 years from start of study | percent of patients recruited over three years |
| Adherence to TiMBRe | From enrollment to end of treatment at 8 weeks | percent of TiMBRe participants to complete the baseline and 8 weeks patient report measures |
| Practicality of TiMBRe | 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
| Measure | Time frame | Description |
|---|---|---|
| Identification of facilitators and barriers to virtual TiMBRe participation | 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. |
| Change in Anxiety management | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobert Knoerl
University of Michigan Rogel Cancer Center
Outcome results
None listed