Describing the Comparative Effectiveness of Colorectal Cancer Screening Tests: The Impact of Quantitative Information
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 728
- 试验地点
- 2
- 主要终点
- Colorectal Cancer (CRC) Screening Intention: Change From Baseline to Post-intervention
研究概览
简要总结
Experts believe that increasing the low uptake of screening for colorectal cancer (CRC) requires educating patients about all approved tests and helping them choose one that fits their preferences. As one motto puts it: "The best test is the one that gets done." Screening tests range from more invasive and very sensitive for polyps and cancer (colonoscopy) to less invasive and less sensitive (e.g., fecal immunochemical testing (FIT)). But it is unclear how best to educate patients about the options and the tradeoffs involved. Some guidelines recommend that decision aids, a promising tool in this area, provide patients with detailed quantitative information, including baseline risk, risk reduction, and chance of negative outcomes. But this sort of "comparative effectiveness" data can confuse patients, especially those with limited mathematical ability. Previous studies have not measured the effect of providing quantitative information to patients with varying levels of ability or interest or asked them whether such data is essential for their decision-making.
The investigators will conduct a clinical trial to determine the impact on patients who view a decision aid (DA) that includes quantitative information versus a DA without such data. The investigators will also seek to determine whether numeracy moderates the effect of quantitative information.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have not had colonoscopy performed in last 10 years, sigmoidoscopy in last 5 years, or fecal occult blood testing (including FIT) in last 1 year and
- •have a scheduled appointment or due to schedule an appointment with a healthcare practitioner at our performance sites.
排除标准
- •undergoing workup for symptoms consistent with colon cancer, such as weight loss or rectal bleeding
- •have a diagnosis or medical history conferring elevated risk for CRC including polypectomy or colon cancer, inflammatory bowel disease, certain inherited syndromes, or a significant family history of CRC
- •are unable to speak and read English.
研究组 & 干预措施
Quantitative
Subjects view:
- A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
- Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
干预措施: DA - Quantitative (Behavioral)
Verbal
Subjects view:
- A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
- Computer-based presentation providing verbal information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.
干预措施: DA - Verbal (Behavioral)
结局指标
主要结局
Colorectal Cancer (CRC) Screening Intention: Change From Baseline to Post-intervention
时间窗: 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])
Multiple choice question assessing subject's intention in getting a CRC screening test in the next 6 months. The response options were: 5=Definitely, 4=Probably, 3=May or may not, 2=Probably not, and 1=Definitely not. Higher positive change means CRC screening intention increased. Increased intention to be screened is a better outcome.
Colorectal Cancer (CRC) Screening Completion
时间窗: 6 months post intervention
Completion of colonoscopy, fecal immunochemical testing (FIT), or other CRC screening test within 6 months of enrollment, based on documentation in the participants' electronic health record. If a patient completed both screening tests and the colonoscopy was a follow-up to a positive FIT, they were considered having completed a FIT only. If the FIT was negative and the patient still had a colonoscopy, they were considered to have completed both tests.
次要结局
- Decision Conflict: Change in Conflict From Baseline to Post-intervention(1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid]))
- Knowledge of Colorectal Cancer (CRC) and Colorectal Cancer Screening: Change in Number of Correct Answers From Baseline to Post-intervention(1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid]))
- Perceived Risk of Colorectal Cancer (CRC): Change From Baseline to Post-intervention(1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid]))
- Perceived Benefits of Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) and Colonoscopy: Change From Baseline to Post-intervention(1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid]))
- Perceived Barriers to Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) or Colonoscopy: Change From Baseline to Post-intervention(1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid]))
- Number of Patients With High and Low Subjective Numeracy(1 day)
研究者
Peter Schwartz
Assistant Professor of Medicine
Indiana University