Colorectal Cancer Screening Assessment Study in American Samoa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 264
- 试验地点
- 4
- 主要终点
- Use of FOBT ColoCARE Home Kit
研究概览
简要总结
This study, led by the American Samoa Community Cancer Coalition's INdigenous Samoan Partnership to Initiate Research Excellence (INSPIRE) and the UH Cancer Center's project team including Dr. Cassel, will utilize a community-based and culturally relevant process to assess the uptake of fecal occult blood testing (FOBT) using tailored colorectal cancer patient education materials for those with inadequate health literacy. Our primary outcomes include: 1) process to develop "suitable" and "comprehensible" health promotion materials for populations in English and Samoan with various health literacy levels, 2) commitment to use the FOBT Colocare home kit, and 3) use of a FOBT Colocare home kit.
详细描述
Utilizing the Behavioral Model of Health Services Use as a conceptual framework and the evidence-based program "Against Colorectal Cancer in Our Neighborhoods" (ACCION) for the Latino population in Texas as a guide, the proposed study will conduct a randomized controlled trial of Indigenous Samoan participants (N=312), age≥ 50 recruited using Respondent-Driven Sampling (RDS). This design will compare use of non-tailored instruction for completing ColoCare FOBT home-kits (N=156) versus the experimental condition, using a ColoCare FOBT home-kit with instructions tailored to low health literacy and to enhance CRC-Knowledge Attitudes and Behavior (KAB) - (N=156). Our goal is to test the influence of tailored materials on timely completion of CRC screening using the ColoCARE FOBT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Resident of America Samoa
- •Over age 50
- •Have not been diagnosed or treated for colon cancer
- •Is not high risk for CRC by having family history or diagnosed with irritable bowel syndrome
- •Can read and speak English and Samoan (can provide written informed consent)
- •Have a home address and working phone
- •Is willing to provide information on their health behaviors
排除标准
- •persons who indicate they speak or read and write Samoan or English less than well
结局指标
主要结局
Use of FOBT ColoCARE Home Kit
时间窗: 3 months
Number of participants reporting results for the FOBT ColoCARE Home kit
Increase Uptake of FOBT ColoCARE Home Kit
时间窗: 2 months
Change in CRC-Knowledge Attitudes and Behavior (KAB) among subjects who viewed the tailored ColoCARE video. This measure is a 7 question assessment given before and after participants viewed the ColoCARE video. Participants were scored based on their pre and post assessment responses.
Modified Patient Education Materials
时间窗: 1 Month
Use a combination of inadequate health literacy recommendations, suitable, and comprehensible assessment methods to develop modified culturally appropriate patient education materials for Colorectal Cancer (CRC). Each of the 22 items within the 6 identified categories are given a score of 0 - 2 based upon certain criteria. Total scores are calculated into percentages and 100% to 70% is "adequate", "69% to 40%" is "marginal, while 39% - 0% is "inadequate".
次要结局
未报告次要终点