CREATE: Art for Children With Cancer

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mia Nolting; Phone Number: 503-494-6234; Email: jordanju@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • OHSU Knight Cancer Institute
      • Contact: Jennifer L. Raybin; Phone Number: 503-418-5150; Email: raybin@ohsu.edu
      • Principal Investigator: Jennifer L. Raybin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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). Parent/caregiver of child participant may be Spanish speaking
• Physically and cognitively able to participate in creative arts
• Expected to receive enough treatment at local site to participate in all four intervention sessions

Exclusion Criteria:

• Not English literate
• Otherwise unable to complete study procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Phase I (focus group); Patients participate in focus groups to develop CrA intervention on study.	Other: Survey Administration; Ancillary studies; Procedure: Discussion; Participate in art focus group, art-making; Other Names: Discuss, creating art
Experimental: Phase II arm I (CrA); 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.	Other: Survey Administration; Ancillary studies; Procedure: Art Therapy; Participate in CrA
Active Comparator: Phase II arm II (watch videos); Patients passively watch videos for 30 minutes once a week for 4 sessions over 12 weeks.	Other: Survey Administration; Ancillary studies; Other: Media Intervention; Watch videos

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that complete all interventions and data collection time points	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.	Up to day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that complete all interventions and all surveys in the study.	Goal of 80% of recruited participants. Will use 95% confidence intervals to estimate the precision of all point estimates.	Up to 24 months
Number of intervenor fidelity surveys that obtain at least 95% score.	Will use 95% confidence intervals to estimate the precision of all point estimates.	Up to 24 months
Comparison of scores on the PRO-CTCAE between intervention arms	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.	Up to 24 months
Comparison of scores on the PROMIS between intervention arms	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.	Up to 24 months
Comparison of scores on the Faces between intervention arms	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.	Up to 24 months
Number of eligible participants that enroll in the study (feasibility threshold of 80%)	Will use 95% confidence intervals to estimate the precision of all point estimates.	Up to to 24 months

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University; National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Jennifer L Raybin, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Therapeutics; Complementary Therapies; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Sensory Art Therapies; Art Therapy
• Other Study ID Numbers: STUDY00026814 (Other Identifier: OHSU Knight Cancer Institute); NCI-2024-01534 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R34AT012497 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will share by publishing in an ICMJE journal and will also submit data and metadata to the Dyad data repository.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No