Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5,500
- 试验地点
- 1
- 主要终点
- Blood-Based Screening Test (BBST) Follow-Up
研究概览
简要总结
The goal of this prospective implementation study is to understand the impact of a blood-based screening test (BBST) for colorectal cancer (CRC) on patient acceptability of and adherence to CRC screening as well as the rate of follow-up BBST in those with negative BBST at a 1-year interval.
Additional aims include assessing the impact of digital patient navigation intervention on the rate of follow-up colonoscopy in individuals with positive BBST. Patients will be randomized into the non-intervention arm or the intervention with an app arm.
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
- 45 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients aged 45-84 years of age
- •Considered by health-care providers to be "average risk" for CRC as determined by USPSTF guidelines
- •If a patient opts for BBST, they are able and willing to provide blood samples per protocol
- •Ability to understand and the willingness to participate in the study
- •Must have been seen in HTPN clinic within the past 24 months from study activation
- •Must have active MyBSW app portal account and/or establish account during study recruitment
排除标准
- •Patients with a personal history of CRC
- •Patients with a known high-risk family history of CRC precluding the patient from being average risk
- •Patients with known diagnosis of inflammatory bowel disease or history of polyps
- •Patients who are currently symptomatic for CRC such as: blood in the stool
- •Patients with any known medical condition which, in the opinion of the investigator, should preclude enrollment into the study
- •Have a recorded up to date CRC screening in the EMR (within 1 year for FIT, 3 years for mt-sDNA, 10 years for colonoscopy)
- •Patients with a previous abnormal colonoscopy finding who are due for surveillance.
研究组 & 干预措施
App Intervention
Patients on the app intervention arm will receive educational messages via their healthcare portal smartphone app.
干预措施: Educational Information via Smartphone App (Other)
Standard Support
Patients on the standard support arm who receive a positive blood test result and either do not access their healthcare portal smartphone app and/or do not schedule a colonoscopy within 2 weeks of the blood test result will receive the standard patient navigation support offered which typically includes explanation and education regarding their positive test result and referral to a gastroenterologist or other proceduralist for a colonoscopy.
结局指标
主要结局
Blood-Based Screening Test (BBST) Follow-Up
时间窗: 1 year after initial result
Assess the number of patients with a negative BBST result who accept and complete a follow-up BBST.
次要结局
- Patient Screening Test Preference(1 year)
- Screening Rates(1 year)
- Intervention Efficacy(1 year)