CREATE: Clinical Research Examining the Arts as Targeted Elements in Childhood Cancer Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Number of participants that complete all interventions and data collection time points
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Not English literate
- •Otherwise unable to complete study procedures
研究组 & 干预措施
Phase II arm II (watch videos)
Patients passively watch videos for 30 minutes once a week for 4 sessions over 12 weeks.
干预措施: Media Intervention (Other)
Phase II arm II (watch videos)
Patients passively watch videos for 30 minutes once a week for 4 sessions over 12 weeks.
干预措施: Survey Administration (Other)
Phase II arm I (CrA)
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.
干预措施: Survey Administration (Other)
Phase I (focus group)
Patients participate in focus groups to develop CrA intervention on study.
干预措施: Survey Administration (Other)
Phase I (focus group)
Patients participate in focus groups to develop CrA intervention on study.
干预措施: Discussion (Procedure)
Phase II arm I (CrA)
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.
干预措施: Art Therapy (Procedure)
结局指标
主要结局
Number of participants that complete all interventions and data collection time points
时间窗: Up to day 90
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.
次要结局
- Number of eligible participants that enroll in the study (feasibility threshold of 80%)(Up to 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)
- 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 Faces between intervention arms(Up to 24 months)
研究者
Jenny Raybin
Principal Investigator
OHSU Knight Cancer Institute