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NCT Number: NCT06342453

CREATE: Art for Children With Cancer

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.

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Key information

Conditions

Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Jennifer L. Raybin

CONTACT

[email protected]

503-418-5150

Jennifer L. Raybin

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Art Therapy

Procedure

Participate in CrA

Discussion

Procedure

Participate in art focus group, art-making

Other names: Discuss, creating art

Media Intervention

Other

Watch videos

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Number of participants that complete all interventions and data collection time points

    Time frame: 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

  1. Number of eligible participants that enroll in the study (feasibility threshold of 80%)

    Time frame: Up to to 24 months

    Will use 95% confidence intervals to estimate the precision of all point estimates.

  2. Number of participants that complete all interventions and all surveys in the study.

    Time frame: Up to 24 months

    Goal of 80% of recruited participants. Will use 95% confidence intervals to estimate the precision of all point estimates.

  3. Number of intervenor fidelity surveys that obtain at least 95% score.

    Time frame: Up to 24 months

    Will use 95% confidence intervals to estimate the precision of all point estimates.

  4. Comparison of scores on the PRO-CTCAE between intervention arms

    Time frame: 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.

  5. Comparison of scores on the PROMIS between intervention arms

    Time frame: 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.

  6. Comparison of scores on the Faces between intervention arms

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mia Nolting

CONTACT

[email protected]

503-494-6234

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • Oregon Health and Science University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2024
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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