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Trial Title:
Examining Arts as Therapy in Children With Cancer, CREATe Trial
NCT ID:
NCT06342453
Condition:
Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Art Therapy
Description:
Participate in CrA
Arm group label:
Phase II arm I (CrA)
Intervention type:
Procedure
Intervention name:
Discussion
Description:
Participate in art focus group, art-making
Arm group label:
Phase I (focus group)
Other name:
Discuss, creating art
Intervention type:
Other
Intervention name:
Media Intervention
Description:
Watch videos
Arm group label:
Phase II arm II (watch videos)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Phase I (focus group)
Arm group label:
Phase II arm I (CrA)
Arm group label:
Phase II arm II (watch videos)
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.
Criteria for 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
Gender:
All
Minimum age:
8 Years
Maximum age:
13 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
OHSU Knight Cancer Institute
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer L. Raybin
Phone:
503-418-5150
Email:
raybin@ohsu.edu
Investigator:
Last name:
Jennifer L. Raybin
Email:
Principal Investigator
Start date:
June 4, 2024
Completion date:
March 30, 2026
Lead sponsor:
Agency:
OHSU Knight Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Oregon Health and Science University
Agency class:
Other
Collaborator:
Agency:
National Center for Complementary and Integrative Health (NCCIH)
Agency class:
NIH
Source:
OHSU Knight Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06342453
