Culturally Adapted Multilevel Decision Support Navigation Trial To Reduce Colorectal Cancer Disparity Among At-Risk Asian American Primary Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Colorectal cancer screening test-specific adherence at 6 months (Stool Blood Test)
研究概览
简要总结
The objective of the study is to conduct a randomized controlled trial to determine the impact of a multi-level culturally-sensitive decision support intervention on colorectal cancer screening adherence among 400 Chinese and Korean American primary care patients.
详细描述
This study culturally adapts existing evidence-based decision support navigation intervention and tests its efficacy among 200 Chinese and Korean American men and 200 Chinese and Korean American women aged 50 to 75 eligible for colorectal cancer screening. Participants are recruited from primary care physician clinics. The study is designed to compare colorectal cancer screening outcomes between the decision support navigation intervention and the advanced control. Those randomized to the advanced control group only receives an informational booklet, a stool blood test kit and a reminder by mail. Those randomized to the decision support navigation intervention group receives everything the advanced control group receives as well as decision support and navigation contacts. Investigators in the study develop an individualized screening plan using a theory-based online Decision Counseling Program, share the plan with the participants' primary care physicians, and have primary care physicians to encourage the colorectal cancer screening to participants. Using outcomes data collected by survey and medical record review, this study: (1) determines overall colorectal cancer screening adherence in the culturally adapted decision support navigation intervention vs. the advanced control; (2) measures change in colorectal cancer screening decision stage in the culturally adapted decision support navigation intervention vs. the advanced control; and (3) assesses colorectal cancer screening test-specific (stool blood test vs. colonoscopy) adherence in the culturally adapted decision support navigation intervention vs. the advanced control. Additionally, investigators in the study evaluate intervention reach, effectiveness, adoption, implementation, and maintenance using interview data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female Chinese and Korean American patients aged 50 to 75, who are not up to date for colorectal cancer screening
排除标准
- •Those with a family history, previous history of removing polyps, inflammatory bowel disease, or diagnosis of colorectal cancer screening.
结局指标
主要结局
Colorectal cancer screening test-specific adherence at 6 months (Stool Blood Test)
时间窗: 6 months
Measure the fraction of participants who undergo a stool blood test at 6 months.
Colorectal cancer screening test-specific adherence at 12 months (Colonoscopy)
时间窗: 12 months
Measure the fraction of participants who undergo a colonoscopy at 12 months.
Colorectal cancer screening adherence at 6 months by self-report
时间窗: 6 months
Measure overall colorectal cancer screening adherence at 6 months by self-report during 6-month survey (by phone).
Colorectal cancer screening decision stage at baseline (Stool Blood Test)
时间窗: Baseline
Measure colorectal cancer screening decision stage for stool blood test at baseline.
Colorectal cancer screening decision stage at baseline (Colonoscopy)
时间窗: Baseline
Measure colorectal cancer screening decision stage for colonoscopy at baseline.
Colorectal cancer screening decision stage at 6 months (Colonoscopy)
时间窗: 6 months
Measure colorectal cancer screening decision stage for colonoscopy at 6 months.
Change in colorectal cancer screening decision stage between baseline and 6 months (Colonoscopy)
时间窗: Baseline and 6 months
Measure change in colorectal cancer screening decision stage for colonoscopy between baseline and 6 months.
Overall colorectal cancer screening adherence at 12 months by self-report
时间窗: 12 months
Measure overall colorectal cancer screening adherence at 12 months by self-report (by phone interview).
Change in colorectal cancer screening decision stage between baseline and 6 months (Stool Blood Test)
时间窗: Baseline and 6 months
Measure change in colorectal cancer screening decision stage for stool blood test between baseline and 6 months.
Colorectal cancer screening adherence at 6 months by medical record review
时间窗: 6 months
Measure overall colorectal cancer screening adherence at 6 months by medical record review.
Overall colorectal cancer screening adherence at 12 months by medical record review
时间窗: 12 months
Measure overall colorectal cancer screening adherence at 12 months by medical record review.
Colorectal cancer screening test-specific adherence at 6 months (Colonoscopy)
时间窗: 6 months
Measure the fraction of participants who undergo a colonoscopy at 6 months.
Colorectal cancer screening test-specific adherence at 12 months (Stool Blood Test)
时间窗: 12 months
Measure the fraction of participants who undergo a stool blood test at 12 months.
Colorectal cancer screening decision stage at 6-months (Stool Blood Test)
时间窗: 6 months
Measure colorectal cancer screening decision stage for stool blood test at 6 months.
次要结局
- Knowledge about colorectal cancer and colorectal cancer screening (Baseline)(Baseline)
- Knowledge about colorectal cancer and colorectal cancer screening (6 months)(6 months)
- Change in knowledge about colorectal cancer and colorectal cancer screening between baseline and 6 months(Baseline and 6 months)
研究者
Sunmin Lee
Professor
University of California, Irvine