Evaluating the Effectiveness of A Proposed 11-Step Community-Based Interventional Program That Educates, Assesses Risk And Overcomes Barriers to Complete Screening Colonoscopy Among Average Risk African Americans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 2
- 主要终点
- Difference in paired pre-/post-test score
研究概览
简要总结
The burden of colorectal cancer (CRC) is unequal among various populations within the United States. This inequality is most notable among African Americans, who exhibit the highest CRC mortality of all US populations. This study aims to evaluate a community-based intervention to educate, assess risk, and overcome barriers to screening among African Americans who are 45 years or older with no personal history of CRC, adenomas, or inflammatory bowel disease and have no family history of CRC.
Barriers being assessed include: Need for establishing care with primary care physician, need for financial assistance, need for reminder calls, need for transportation, need for appointment coordination, and need for education about colonoscopy preparation and procedure
详细描述
After reviewing the existing literature this study team believes that the proposed strategy is inherently unique, thus amenable to experimental inquiry.
The study will provide much needed data to define the extent to which the proposed multi-faceted approach may be effectively deployed to the target population. This includes the acquisition of data to evaluate the educational program, for which improvement in knowledge may be tested objectively using the study design, as well as survey and feasibility data which is pivotal for improving the strategy.
The 11 steps for completing cancer screening are listed below:
- Demographic/Socio-economic information
- Knowledge assessment and education
- Risk assessment questionnaire "Am I Average Risk?"
- Do I need screening colonoscopy?
- Barriers to colorectal cancer screening
- Outreach program evaluation
- Participants data entered in REDCap database
- Communication with primary care provider and navigator
- Participant navigation
- Evaluation of navigation services
- Program monitoring
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Education Only: African American individuals 18 years and older.
- •CRC colonoscopy screening : Average Risk African American individuals ages 45 - 75 who did not have a screening colonoscopy or other screening modality within the past10 years, have no history of CRC, adenomatous polyps or Inflammatory Bowel Disease (IBD) and no family history of colorectal cancer. This will be identified during outreach events (steps 3 and 4).
- •It is important to note that this program may ultimately include all races as a community outreach event, however we will not analyze the data of non-African Americans.
排除标准
- •African American individuals under the age of 18
- •Colonoscopy within 10 years
- •History of CRC, Adenoma, IBD
- •Family history of CRC
- •Fecal immunochemical test (FIT) within the past year
- •Cologuard test within the past 3 years
- •Flexible Sigmoidoscopy test within the past 5 years
- •Colonography within the past 5 years
结局指标
主要结局
Difference in paired pre-/post-test score
时间窗: From baseline (week 0) to follow-up end of study (week 24)
16 item knowledge questions, where each item is assessed as true, false, or not sure. A 25% improvement of knowledge between pre- and post-test scores will indicate an effective program
次要结局
- Feasibility of Intervention(At the end of education - 24 weeks)
- Percentage of individuals aged 45-75 who have never had colon or rectal cancer screening(At the end of education - 24 weeks)
- Fidelity of intervention(At the end of education - 24 weeks)
- Acceptability of intervention(At the end of education - 24 weeks)
- Barriers faced to scheduling colorectal cancer screening(At the end of education - 24 weeks)
- Percentage of participants who found the Risk assessment questionnaire helpful(At the end of education - 24 weeks)