CREATE: Art for Children With Cancer

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.

• Art Therapy (Procedure): Participate in CrA
• Discussion (Procedure), also known as Discuss, creating art: Participate in art focus group, art-making
• Media Intervention (Other): Watch videos
• Survey Administration (Other): Ancillary studies

Primary outcomes

• 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 outcomes

• 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.
• 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 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.
• 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.

Sex: All, ages: 8 Years to 13 Years

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

• Jennifer L Raybin, PhD RN, Principal investigator, OHSU Knight Cancer Institute

NIH grants: R34AT012497