Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342453
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-03-05
Brief Title:
Examining Arts as Therapy in Children With Cancer CREATe Trial
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
CREATe Clinical Research Examining the Arts as Therapy in Children With Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01534 | REGISTRY | None | None |
| STUDY00026814 | OTHER | None | None |
| R34AT012497 | NIH | OHSU Knight Cancer Institute | httpsreporternihgovquickSearchR34AT012497 |