Gene Environment Risk Assessment and CRC Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 697
- 试验地点
- 1
- 主要终点
- Comparison of Genetic Epidemiology and Risk Assessment (GERA) feedback vs usual care (UC) in terms of colorectal cancer (CRC) screening utilization
研究概览
简要总结
RATIONALE: The Genetic Epidemiology and Risk Assessment program may be more effective than usual care in increasing the number of healthy participants who regularly receive screening for colorectal cancer.
PURPOSE: This randomized clinical trial is studying the Genetic Epidemiology and Risk Assessment program to see how well it works compared with usual care to increase colorectal cancer screening in healthy participants.
详细描述
OBJECTIVES:
- Compare Genetic Epidemiology and Risk Assessment (GERA) feedback vs usual care (UC) in terms of colorectal cancer (CRC) screening utilization by healthy participants.
- Determine the impact of GERA feedback and UC on psychological distress in these participants.
- Compare GERA feedback vs UC in terms of intention to have CRC screening, perceived CRC risk, CRC knowledge, salience and coherence of CRC screening, and support for CRC screening in these participants.
- Identify factors that moderate the impact of GERA feedback on CRC screening utilization.
OUTLINE: This is a randomized study. Participants are randomized to 1 of 2 screening arms.
- Arm I: Participants receive standard primary care.
- Arm II: Participants receive standard primary care followed by the Genetic Epidemiology and Risk Assessment (GERA) intervention. Participants also participate in a discussion session regarding the GERA including the rationale behind methylenetetrahydrofolate reductase mutation detection and folate assessment and its relationship to colorectal cancer risk.
All participants undergo a fecal occult blood test 3 weeks after the screening office visit.
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
- 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
- •DISEASE CHARACTERISTICS:
- •Healthy participants meeting the following criteria:
- •No personal history of colorectal polyps or cancer or inflammatory bowel disease
- •No family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer (CRC), or CRC in more than 1 first-degree relative
- •Nonadherent with standard CRC screening recommendations at the time of their index office visit
- •PATIENT CHARACTERISTICS:
- •Able to communicate with ease in English
- •PRIOR CONCURRENT THERAPY:
- •More than 6 weeks since prior antibiotics or antifolate medications (e.g., sulfasalazine, methotrexate)
排除标准
- 未提供
研究组 & 干预措施
Arm I
Participants receive standard primary care.
Arm II
Participants receive standard primary care followed by the Genetic Epidemiology and Risk Assessment (GERA) intervention. Participants also participate in a discussion session regarding the GERA including the rationale behind methylenetetrahydrofolate reductase mutation detection and folate assessment and its relationship to colorectal cancer risk.
干预措施: counseling intervention (Other)
Arm II
Participants receive standard primary care followed by the Genetic Epidemiology and Risk Assessment (GERA) intervention. Participants also participate in a discussion session regarding the GERA including the rationale behind methylenetetrahydrofolate reductase mutation detection and folate assessment and its relationship to colorectal cancer risk.
干预措施: educational intervention (Other)
结局指标
主要结局
Comparison of Genetic Epidemiology and Risk Assessment (GERA) feedback vs usual care (UC) in terms of colorectal cancer (CRC) screening utilization
时间窗: At study completion
Impact of GERA feedback and UC on psychological distress
时间窗: At study completion
Comparison of GERA feedback vs UC in terms of intention to have CRC screening, perceived CRC risk, CRC knowledge, salience and coherence of CRC screening, and support for CRC screening
时间窗: At study completion
Factors that moderate the impact of GERA feedback on CRC screening utilization
时间窗: At study completion
次要结局
未报告次要终点