CREATe: Clinical Research Examining the Arts as Therapy in children with cancer - Abstract: For the more than 40,000 children undergoing treatment for cancer each year, there is an urgent need to establish scalable complementary health interventions to treat symptoms not controlled by conventional supportive care. Complementary health interventions have been associated with decreased distress, anxiety, pain, and improved quality of life (QOL) in children with cancer. Creative arts therapy and art-making are mind-body interventions that have been related to improved QOL in adults and children with cancer, but foundational evidence lacks rigor and reproducibility. To address this gap, we will use art focus groups with children with cancer to develop a standardized creative arts intervention based on what we learned from our pilot studies. We will then establish feasibility of conducting a randomized controlled trial in 60 children ages 8-13 years in the first year of cancer treatment. This study will occur in two phases. Phase 1 will define and refine the intervention using art groups with participants who represent the future study population. Phase 2 will assess feasibility and acceptability of a 12-week two-arm trial. The intervention arms will consist of four 30-minute sessions of either creative arts or video watching during scheduled cancer treatment every 2-3 weeks over 12-weeks. Patient-reported QOL and symptom outcomes showed significant change in our preliminary work, but we will advance the measures for scalability with the standardized questionnaires: Pediatric PROMIS, Pediatric Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE), and Faces scale. Timepoints for data capture will occur at baseline, pre-/post- each session, and after the total 12-week intervention. Our multidisciplinary study team contributes congruent areas of expertise in clinical research among children with cancer, creative arts intervention development, pediatric symptom assessment, behavioral clinical trial implementation, and feasibility data analysis. This research has the potential to promote the integration of creative arts into conventional cancer care for children and transform the future of symptom management. The outcomes will strengthen the design and overcome methodological challenges in the clinical study of an innovative mind-body intervention for addressing QOL and symptom burden to improve the whole person health of children with cancer.
