Clinical trial NCT06342453: Examining Arts as Targeted Elements of Childhood Cancer Treatment, CREATe Trial
Official title: CREATe: Clinical Research Examining the Arts as Targeted Elements of Childhood Cancer Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-04-02
Enrollment: 72
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

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)
* Physically and cognitively able to participate in creative arts

Exclusion Criteria:

* Not English literate
* Otherwise unable to complete study procedures

Primary outcomes:
measure: Number of participants that complete all interventions and data collection time points
timeFrame: Up to day 90
Secondary outcomes:
measure: Number of eligible participants that enroll in the study (feasibility threshold of 80%)
timeFrame: Up to to 24 months
measure: Number of participants that complete all interventions and all surveys in the study.
timeFrame: Up to 24 months
measure: Number of intervenor fidelity surveys that obtain at least 95% score.
timeFrame: Up to 24 months
measure: Comparison of scores on the PRO-CTCAE between intervention arms
timeFrame: Up to 24 months
measure: Comparison of scores on the PROMIS between intervention arms
timeFrame: Up to 24 months
measure: Comparison of scores on the Faces between intervention arms
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Jennifer L Raybin
role: PRINCIPAL_INVESTIGATOR
References: