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| ID | Type | Description | Link |
|---|---|---|---|
| R34AT012497 | U.S. NIH Grant/Contract | View source | |
| NCI-2024-01534 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00026814 | Other Identifier | OHSU Knight Cancer Institute |
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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I (focus group) | Active Comparator | Patients participate in focus groups to develop CrA intervention on study. |
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| 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. |
|
| Phase II arm II (watch videos) | Active Comparator | Patients passively watch videos for 30 minutes once a week for 4 sessions over 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Art Therapy | Procedure | Participate in CrA |
| |
| Discussion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to to 24 months |
| Number of participants that complete all interventions and all surveys in the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mia Nolting | Contact | 503-494-6234 | jordanju@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer L Raybin | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Recruiting | Portland | Oregon | 97239 | United States |
Will share by publishing in an ICMJE journal and will also submit data and metadata to the Dyad data repository.
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| ID | Term |
|---|---|
| D001155 | Art Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Procedure |
Participate in art focus group, art-making |
|
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| Media Intervention | Other | Watch videos |
|
| Survey Administration | Other | Ancillary studies |
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Goal of 80% of recruited participants. Will use 95% confidence intervals to estimate the precision of all point estimates. |
| 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. | 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. | 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. | 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. | Up to 24 months |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |