Participatory Research to Advance Colon Cancer Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27,580
- 试验地点
- 2
- 主要终点
- Increased colorectal cancer screening rates
研究概览
简要总结
The overall goal of this study is to test strategies to raise rates of colorectal cancer screening among the Latino population in a federally qualified health center that operates multiple clinics. This intervention study will test automated and live prompts to a direct-mail fecal testing program in two phases.
In Phase I (Years 01 - 02), the investigators will tailor and define intervention components using a community-based participatory research approach called boot camp translation (BCT). The ultimate design of the intervention will be defined by patient and provider feedback from BCT. The investigators will then conduct a three-arm patient-randomized comparative effectiveness trial in two pilot clinics to compare 1) automated prompts (i.e., automated phone calls, text messages) to alert and remind patients to complete screening, 2) live prompts (i.e., live phone calls), and 3) a combination approach of automated plus live prompts.
In Phase II (Years 03 - 05), the investigators will spread and test the spread of the adapted intervention to additional clinics within the partnering health center using a two-arm main trial.
Both phases will be guided by an advisory group of clinicians, researchers, policy makers, and patients.
详细描述
The study will fulfill the following aims:
Aim 1: Develop personalized messages (e.g., phone scripts, text messages, patient portal prompts) and define an intervention using boot camp translation to increase colon cancer screening among Latino populations.
Aim 2: Assess the reach, effectiveness, and differences by subgroup (e.g., preferred language) of a three-arm colorectal cancer screening program among Latino FQHC patients, in 2 clinics, through a patient randomized-controlled trial.
In addition to Usual Care, the arms are:
- Automated Prompts-an automated data-driven program for delivering FIT kit prompts (using automated phone calls, text messages, and/or emails) to patients due for colorectal cancer screening.
- Automated Plus Live Prompts-a higher-intensity program using automated, data-driven strategies for delivering FIT kit prompts plus linguistically and culturally tailored live prompts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
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
- •Persons aged 50-75 years and not up-to-date with colorectal cancer screening
排除标准
- •Persons having colorectal disease (e.g., ulcerative colitis or colectomy), personal history of colorectal cancer or colorectal disease, end-stage or life threatening diseases or, those known to be under hospice care or living in a skilled nursing facility may be excluded.
结局指标
主要结局
Increased colorectal cancer screening rates
时间窗: Up to 4 years (study period)
Fecal testing completion
次要结局
未报告次要终点