Pilot Randomized Controlled Trial Assessing the Impact of Protect Your Colon™ on Colorectal Cancer Screening Behaviors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Rate of completion of a CRC screening test
研究概览
简要总结
The purpose of the research is to assess the impact of Protect Your Colon™, a colorectal cancer (CRC) screening decision aid, on patients' CRC screening behaviors. The Investigators hypothesize that Protect Your Colon™, through optimizing shared decision making, will lead to selection of a test that accurately matches patients' values and increase CRC screening uptake. To test this hypothesis, the investigators will conduct a pilot randomized controlled trial (RCT) to assess if provision of Protect Your Colon™ improves communication on CRC screening, intent to complete screening, and ultimately uptake of screening vs. usual care.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals 45 to 75 years old
- •No prior CRC screening or not up-to-date with CRC screening
- •Not at high risk for CRC (e.g., inflammatory bowel disease, colon polyposis syndromes, family history of CRC)
- •No prior colon polyps
- •Additional inclusion criteria for participants recruited through Cint online survey panels: (i) appointment with a primary care provider up to 6 weeks from time of screening, and (ii) have Preferred Provider Organization (PPO) insurance.
排除标准
- •Does not speak English
- •Does not have internet access
- •Any records flagged "break the glass" or "research opt out."
研究组 & 干预措施
Protect Your Colon™ (Intervention)
Patients randomized to Protect Your Colon™ will be directed to go through the website before their clinic appointment. Those who finish the decision aid will then review their personalized report which details their priorities in selecting a screening test as well as the test that best matches their values. Patients will also be encouraged to bring their personalized report with them to the visit to discuss with their doctor. All intervention participants will also receive a reminder via email one day before their scheduled clinic visit. They will be reminded to go through the Protect Your Colon™ website before the clinic visit and to bring their personalized report with them to the visit.
干预措施: Protect Your Colon™ (Behavioral)
Usual Care (Control)
The usual care group will be managed according to the providers' customary practices: CRC screening discussions, if any, are at the discretion of the provider as Cedars-Sinai does not employ a standardized approach. Patients randomized to the control arm will not be sent any materials before their clinic appointment.
结局指标
主要结局
Rate of completion of a CRC screening test
时间窗: 6 months post visit
Uptake of CRC screening within 6 months of patients' initial visit
次要结局
- Qualitative feedback on details of CRC screening test(1 day post visit)
研究者
Christopher Almario
Assistant Professor
Cedars-Sinai Medical Center