Examining Arts as Therapy in Children With Cancer, CREATe Trial

Malignant Solid Neoplasm Clinical Trial

Official title:

CREATe: Clinical Research Examining the Arts as Therapy in Children With Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06342453
• Other study ID #: STUDY00026814
• Secondary ID: NCI-2024-01534ST
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: March 30, 2026

Study information

• Verified date: March 2024
• Source: OHSU Knight Cancer Institute
• Contact: Julia Jordan
• Phone: 503-494-6234
• Email: jordanju[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: March 30, 2026
• Est. primary completion date: March 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Malignant Solid Neoplasm
• Neoplasms

Intervention

Procedure:
• Art Therapy
Participate in CrA
• Discussion
Participate in art focus group, art-making

Other:
• Media Intervention
Watch videos
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Center for Complementary and Integrative Health (NCCIH), Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of eligible participants that enroll in the study (feasibility threshold of 60%)	Will use 95% confidence intervals to estimate the precision of all point estimates.	Up to to 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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