Feasibility of Virtual, Tailored, Music-Based Relaxation for Anxiety in Adolescent and Young Adult Cancer Survivors
- Conditions
- Anxiety
- Interventions
- Other: TiMBReOther: Control
- Registration Number
- NCT05911269
- Lead Sponsor
- University of Michigan Rogel Cancer Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description TiMBRe 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. Attention-Control Control Standard of care study staff calls and cancer survivorship resources
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States