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

Not Applicable

Recruiting

• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Interventions: Other: Media Intervention; Procedure: Discussion; Procedure: Art Therapy; Other: Survey Administration

• Registration Number: NCT06342453
• Lead Sponsor: OHSU Knight Cancer Institute

Brief 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.

Study Timeline

• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-26
• Study First Posted: 2024-04-02
• Study Start: 2024-06-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2026-03-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase II arm II (watch videos)	Media Intervention	Patients passively watch videos for 30 minutes once a week for 4 sessions over 12 weeks.
Phase II arm II (watch videos)	Survey Administration	Patients passively watch videos for 30 minutes once a week for 4 sessions over 12 weeks.
Phase I (focus group)	Discussion	Patients participate in focus groups to develop CrA intervention on study.
Phase II arm I (CrA)	Survey Administration	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.
Phase I (focus group)	Survey Administration	Patients participate in focus groups to develop CrA intervention on study.
Phase II arm I (CrA)	Art Therapy	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.

Primary Outcome Measures

Name	Time	Method
Number of participants that complete all interventions and data collection time points	Up to day 90	Will be considered feasible if 80% of participants complete 4 intervention sessions and 3 data collection time points. Will be summarized across and within each study arm using means and standard deviations for continuous variables, and frequency counts and percentages for nominal variables.

Secondary Outcome Measures

Name	Time	Method
Number of eligible participants that enroll in the study (feasibility threshold of 80%)	Up to to 24 months	Will use 95% confidence intervals to estimate the precision of all point estimates.
Comparison of scores on the PRO-CTCAE between intervention arms	Up to 24 months	Will use National Cancer Institute's Pediatric Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities. Answers ranging from None to Very Severe (none=0 to very severe=4); Not at All to Very Much (not at all=0 to very much=4), Never to Almost Constantly (0=never to almost constantly=4). Will be assessed by comparing outcome measure results between arms. Will use 95% confidence intervals to estimate the precision of all point estimates.
Comparison of scores on the PROMIS between intervention arms	Up to 24 months	Will use PROMIS Pediatric Global Health-7 measure, a brief 7-item summary assessment of a child's self-reported health. This measure contains 7 items assessing global health (physical and mental wellbeing. All items are completed on a 5-point Likert scale (1= Poor to 5 = Excellent, or 1 = Never to 5 = Always or Almost always, depending on the domain). Will be assessed by comparing outcome measure results between arms. Will use 95% confidence intervals to estimate the precision of all point estimates.
Number of participants that complete all interventions and all surveys in the study.	Up to 24 months	Goal of 80% of recruited participants. Will use 95% confidence intervals to estimate the precision of all point estimates.
Number of intervenor fidelity surveys that obtain at least 95% score.	Up to 24 months	Will use 95% confidence intervals to estimate the precision of all point estimates.
Comparison of scores on the Faces between intervention arms	Up to 24 months	Will be assessed using a Faces scale with 9 faces in order of happy to sad to assess emotional reactions. Will be assessed by comparing outcome measure results between arms. Will use 95% confidence intervals to estimate the precision of all point estimates.

Trial Locations

Locations (1)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States