Examining Arts as Therapy in Children With Cancer, CREATe Trial

Status Not yet recruiting

Clinical Trial Summary

This clinical trial is being done to develop and test how well creative arts interventions (drawing, painting, making sculptures) compared to watching videos can affect symptoms and impact the quality of life in children with cancer. Creative arts mind-body interventions (CrA) are one type of complementary health interventions which have been associated with improved quality of life and reduced symptom burden among children with cancer. CrA is an ideal intervention for children with cancer due to the long hours spent in the hospital setting for treatments, the creativity and developmental focus of children, and their potential ability to communicate more easily through art than words. Researchers want to develop and test a CrA intervention to help improve symptoms and the quality of life of children with cancer.

Clinical Trial Description

PRIMARY OBJECTIVE: I. Feasibility of an randomized controlled trial (RCT) of art among children with cancer. SECONDARY OBJECTIVES: I. Achieve recruitment rate target. II. Achieve accrual target. III. Achieve fidelity to intervention. IV. Assess initial effect sizes. OUTLINE: PHASE I: Patients participate in focus groups to develop CrA intervention on study. PHASE II: Patients are randomized to 1 of 2 arms. ARM I: Patients participate in CrA interventions comprising drawing, painting, and making sculptures with a trained artist for 30 minutes once a week for 4 sessions over 12 weeks. ARM II: Patients passively watch videos for 30 minutes once a week for 4 sessions over 12 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06342453
Study type	Interventional
Source	OHSU Knight Cancer Institute
Contact	Julia Jordan
Phone	503-494-6234
Email	jordanju@ohsu.edu
Status	Not yet recruiting
Phase	N/A
Start date	May 1, 2024
Completion date	March 30, 2026

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