CREATE: Art for Children With Cancer

NCT06342453 | Recruiting

• 3 other identifiers: STUDY00026814R34AT012497NCI-2024-01534
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

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

  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.

  Up to day 90

Secondary Outcomes (6)

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

  Up to to 24 months

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

  Up to 24 months

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

  Up to 24 months

• Comparison of scores on the PRO-CTCAE between intervention arms

  Up to 24 months

• Comparison of scores on the PROMIS between intervention arms

  Up to 24 months

Study Arms (3)

Phase I (focus group)

ACTIVE COMPARATOR

Patients participate in focus groups to develop CrA intervention on study.

Procedure: Discussion; Other: Survey Administration

Phase II arm I (CrA)

EXPERIMENTAL

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.

Procedure: Art Therapy; Other: Survey Administration

Phase II arm II (watch videos)

ACTIVE COMPARATOR

Patients passively watch videos for 30 minutes once a week for 4 sessions over 12 weeks.

Other: Media Intervention; Other: Survey Administration

Interventions

Art Therapy PROCEDURE

Participate in CrA

Phase II arm I (CrA)

Discussion PROCEDURE

Participate in art focus group, art-making

Also known as: Discuss, creating art

Phase I (focus group)

Media Intervention OTHER

Watch videos

Phase II arm II (watch videos)

Survey Administration OTHER

Ancillary studies

Phase I (focus group); Phase II arm I (CrA); Phase II arm II (watch videos)

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Not English literate
• Otherwise unable to complete study procedures

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Interventions

Art Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jennifer L Raybin

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mia Nolting

CONTACT

503-494-6234; jordanju@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: April 2, 2024
• Study Start: June 4, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)