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

Clinical Problem: Up to 48.5% of adolescent and young adult (AYA, 15 – 39 years old) cancer survivors experience clinically relevant anxiety. Anxiety disrupts the successful achievement of normative developmental tasks and is associated with fear of cancer recurrence and decreased quality of life. Cognitive behavioral therapy is a guideline-based recommendation for anxiety, but only 40% of AYAs seek out such treatments, and stigma regarding psychotherapy is high, particularly among individuals of diverse backgrounds. Overall Objective: Music-based interventions offer an evidence-based treatment for anxiety in adults with cancer. Despite the growth of studies, approximately 8% of trials have included AYA/pediatric cancer patients. The overall objective is to determine the feasibility of conducting an eight-week, (45 min/week), virtuallydelivered, tailored music-based relaxation (TiMBRe) intervention to decrease anxiety in AYA cancer survivors. TiMBRe uses tailored music experiences, delivered by a board-certified music therapist, to develop greater self-awareness and use of music-based relaxation to increase self-efficacy to cope and manage anxiety. Need for Planning Study: The primary aim of our future, phase II, multicenter randomized controlled trial is to determine the efficacy of a virtual, TiMBRe intervention to reduce anxiety in AYA cancer survivors with clinically relevant anxiety. Our preliminary data (N=37) demonstrate that the implementation of a four-session (45 min each), virtual TiMBRe intervention for AYAs with cancer is feasible and well accepted by AYAs, with a majority (13/21, [67%]) of AYAs with anxiety reporting clinically significant changes in their anxiety pre-to postintervention. However, we must first address several planning issues that will prepare the protocol for successful implementation and completion in a randomized controlled trial. R34 Specific Aims: The primary aim is to determine the feasibility of implementing a randomized controlled trial of an eight-week, virtual, TiMBRe intervention in post-treatment AYA cancer survivors with clinically relevant anxiety. Secondarily, we will determine the credibility of an attention control condition for virtual TiMBRe and develop fidelity measures to ensure standardized delivery of virtual TiMBRe across therapists. Methods: Using an explanatory-sequential mixed methods design, we will first randomize 50 AYA cancer survivors with clinically relevant anxiety from the University of Michigan to the eight-week TiMBRe intervention or attention-control (i.e., study staff calls + cancer survivorship resources). Participants will complete patientreported outcome measures (e.g., PROMIS Anxiety 4a) at baseline, four, eight, and twenty weeks. TiMBRe group participants will participate in semi-structured interviews to evaluate intervention acceptability. Expected Outcomes: The expected outcome is the demonstration that virtual TiMBRe intervention delivery is feasible within a randomized-controlled trial, with further data supporting a credible attention control and effective intervention fidelity methods. Results will inform a phase II efficacy trial.