Determining the Feasibility of Virtual, Tailored, Music-Based Relaxation for Anxiety in Adolescent and Young Adult Cancer Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Acceptability of TiMBRe
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 39 Years (Child, Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
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.
Intervention: TiMBRe (Other)
Attention-Control
Standard of care study staff calls and cancer survivorship resources
Intervention: Control (Other)
Outcomes
Primary Outcomes
Acceptability of TiMBRe
Time Frame: up to 8 weeks post start of intervention
mean scores for the Acceptability E-scale Items are ≥ 4/5
Demand of TiMBRe
Time Frame: up to 3 years from start of study
percent of patients recruited over three years
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
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
- Identification of facilitators and barriers to virtual TiMBRe participation(up to 8 weeks post start of intervention)
- Change in Anxiety management(at baseline and eight weeks post initiation of treatment)