Development of the Intervention Protocol for the Study of Creative Arts Among Children With Cancer.
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BackgroundCreative arts interventions improve symptoms among children with cancer, but current evidence lacks rigor and reproducibility. To address this gap, we developed standardized interventions with a subsample representing the study population and conducted feasibility activities for a future randomized controlled trial (RCT).MethodThis study consisted of three parts: (a) define intervention and attention control procedures; (b) enroll participants to test and rate the procedures; and (c) create scalable flowcharts and training curricula. We developed standardized art sessions and an attention control video-watching activity. Participants aged 8-13 years in the first year of cancer treatment were enrolled to complete interventions and rate approval using the Faces Scale. Field notes and photographs were recorded by permission. Responses were used to refine the protocol and create flow diagrams for both arms. We then repeated the activities to confirm participants' ratings remained consistent.ResultsTen participants were enrolled and completed 13 art and six video sessions. No one declined or discontinued early, and four participants completed ≥1 session. All participants rated sessions with at least a happy face. Field notes revealed parents/caregivers were engaged and approved of the study activities. Refinements included simplification of the art supplies, utilizing clinical staff to help navigate the complex treatment schedules, and reframing the artist directions to focus on fostering creativity.DiscussionApproval by child participants and their caregivers helped design the protocol to enable us to conduct the RCT in Aim 2.