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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
72
Participate in CrA
Participate in art focus group, art-making
Watch videos
Ancillary studies
OHSU Knight Cancer Institute
Portland, Oregon, United States
RECRUITINGNumber 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.
Time frame: Up to day 90
Number of eligible participants that enroll in the study (feasibility threshold of 80%)
Will use 95% confidence intervals to estimate the precision of all point estimates.
Time frame: Up to to 24 months
Number of participants that complete all interventions and all surveys in the study.
Goal of 80% of recruited participants. Will use 95% confidence intervals to estimate the precision of all point estimates.
Time frame: Up to 24 months
Number of intervenor fidelity surveys that obtain at least 95% score.
Will use 95% confidence intervals to estimate the precision of all point estimates.
Time frame: Up to 24 months
Comparison of scores on the PRO-CTCAE between intervention arms
Will use National Cancer Institute's Pediatric Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities. Answers ranging from None to Very Severe (none=0 to very severe=4); Not at All to Very Much (not at all=0 to very much=4), Never to Almost Constantly (0=never to almost constantly=4). Will be assessed by comparing outcome measure results between arms. Will use 95% confidence intervals to estimate the precision of all point estimates.
Time frame: Up to 24 months
Comparison of scores on the PROMIS between intervention arms
Will use PROMIS Pediatric Global Health-7 measure, a brief 7-item summary assessment of a child's self-reported health. This measure contains 7 items assessing global health (physical and mental wellbeing. All items are completed on a 5-point Likert scale (1= Poor to 5 = Excellent, or 1 = Never to 5 = Always or Almost always, depending on the domain). Will be assessed by comparing outcome measure results between arms. Will use 95% confidence intervals to estimate the precision of all point estimates.
Time frame: Up to 24 months
Comparison of scores on the Faces between intervention arms
Will be assessed using a Faces scale with 9 faces in order of happy to sad to assess emotional reactions. Will be assessed by comparing outcome measure results between arms. Will use 95% confidence intervals to estimate the precision of all point estimates.
Time frame: Up to 24 months
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