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Recruiting NCT06342453

CREATE: Art for Children With Cancer

No phase Interventional Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Art Therapy, Discussion, Media Intervention, Survey Administration.
Who it may be relevant to
Registry conditions: Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm. Basic parameters: 8 years — 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Art Therapy
    Participate in CrA
  • Procedure Discussion
    Participate in art focus group, art-making
  • Other Media Intervention
    Watch videos
  • Other Survey Administration
    Ancillary studies

Primary outcome measures

  • Number of participants that complete all interventions and data collection time points [Time frame: Up to day 90]
Secondary outcome measures (6)
  • Number of eligible participants that enroll in the study (feasibility threshold of 80%) [Time frame: Up to to 24 months]
  • Number of participants that complete all interventions and all surveys in the study. [Time frame: Up to 24 months]
  • Number of intervenor fidelity surveys that obtain at least 95% score. [Time frame: Up to 24 months]
  • Comparison of scores on the PRO-CTCAE between intervention arms [Time frame: Up to 24 months]
  • Comparison of scores on the PROMIS between intervention arms [Time frame: Up to 24 months]
  • Comparison of scores on the Faces between intervention arms [Time frame: Up to 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • OHSU Knight Cancer Institute — Portland

Identifiers

NCT: NCT06342453 · STUDY00026814 · R34AT012497 · NCI-2024-01534 · STUDY00026814

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗