NCT06342453

CREATE: Art for Children With Cancer

CREATE: Clinical Research Examining the Arts as Targeted Elements in Childhood Cancer Care

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 8 Years – 13 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hematopoietic and Lymphatic System Neoplasm
• Malignant Solid Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Art Therapy	Participate in CrA
PROCEDURE	Discussion	Participate in art focus group, art-making
OTHER	Media Intervention	Watch videos
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2024-06-04
• Primary completion: 2026-07-01
• Completion: 2026-12-31
• First posted: 2024-04-02
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States