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Examining Arts As Targeted Elements of Childhood Cancer Treatment, CREATe Trial

OHSU Knight Cancer Institute logo

OHSU Knight Cancer Institute

Status

Enrolling

Conditions

Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm

Treatments

Other: Media Intervention
Procedure: Discussion
Procedure: Art Therapy
Other: Survey Administration

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06342453
STUDY00026814 (Other Identifier)
NCI-2024-01534 (Registry Identifier)
R34AT012497 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 estimated patients

Sex

All

Ages

8 to 13 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

72 participants in 3 patient groups

Phase I (focus group)
Active Comparator group
Description:
Patients participate in focus groups to develop CrA intervention on study.
Treatment:
Other: Survey Administration
Procedure: Discussion
Phase II arm I (CrA)
Experimental group
Description:
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.
Treatment:
Other: Survey Administration
Procedure: Art Therapy
Phase II arm II (watch videos)
Active Comparator group
Description:
Patients passively watch videos for 30 minutes once a week for 4 sessions over 12 weeks.
Treatment:
Other: Survey Administration
Other: Media Intervention

Trial contacts and locations

1

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Central trial contact

Julia Jordan

Data sourced from clinicaltrials.gov

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