Examining Arts As Targeted Elements of Childhood Cancer Treatment, CREATe Trial

OHSU Knight Cancer Institute

Status: Enrolling

Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Treatments: Other: Media Intervention; Procedure: Discussion; Procedure: Art Therapy; Other: Survey Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06342453

STUDY00026814 (Other Identifier)

NCI-2024-01534 (Registry Identifier)

R34AT012497 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 8 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 8 to 13 years of age
• Have been diagnosed with cancer of any type in the prior 12 months
• Be English literate (we will amend this criterium when the study surveys are validated in Spanish)
• Physically and cognitively able to participate in creative arts

Exclusion criteria

• Not English literate
• Otherwise unable to complete study procedures

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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72 participants in 3 patient groups

Phase I (focus group)

Active Comparator group

Description:

Patients participate in focus groups to develop CrA intervention on study.

Treatment:

Other: Survey Administration

Procedure: Discussion

Phase II arm I (CrA)

Experimental group

Description:

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.

Treatment:

Other: Survey Administration

Procedure: Art Therapy

Phase II arm II (watch videos)

Active Comparator group

Description:

Patients passively watch videos for 30 minutes once a week for 4 sessions over 12 weeks.

Treatment:

Other: Survey Administration

Other: Media Intervention