Clinical Problem: Up to 40% of adolescent and young adult (AYA, 15 – 39 years old) cancer survivors experience moderate-severe 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 and mindfulness-based stress reduction are recommended treatments for anxiety, but only 40% of AYA cancer survivors seek out such treatments, and 1/3 of AYAs seeking treatment report access barriers.
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), virtually-delivered, 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.15
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 moderate-severe 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 (12/18, [67%]) of AYAs with moderate-severe anxiety reporting clinically significant changes in their anxiety pre-to post-intervention.17 However, we must first address several planning issues that will prepare the protocol for successful implementation and completion in a randomized controlled trial.
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 moderate-severe anxiety. Secondarily, we will determine the credibility of an attention control condition for virtual TiMBRe delivery 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 moderate-severe 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 patient-reported outcome measures (e.g., PROMIS Anxiety 4a) at baseline, four weeks, and eight 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 and across multiple sites, with further data supporting a credible attention control and effective intervention fidelity methods. Results will inform a phase II efficacy trial.
