Barrett's Esophagus Screening Towards Rural Referral Pathways: Screening for Esophageal Cancer in Rural Oregon Without Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Feasibility of the use of a SECD: Number of providers who indicate likelihood of using SECD
研究概览
简要总结
Recent advancements in swallowable esophageal cell-collection devices (SECD) offer a safe, minimally invasive, accurate, and low-cost alternative to esophageal screening without the need for an upper endoscopy. The BEST-RPP study aims to evaluate the acceptability and feasibility of using this novel approach to screen for Barrett's Esophagus (BE) and Esophageal Carcinoma (EAC) in rural primary care clinic settings in Oregon.
详细描述
This is a proof-of-concept observational study to pilot the use of an FDA approved swallowable esophageal cell-collection device to screen for esophageal cancer in two rural primary care clinics in Oregon. The principal investigator will work with clinic staff to gauge the current use and understanding of SECDs as screening tools for esophageal cancer and to identify 50 patients at each site to approach about SECDs as an option for screening, for a total of 100 patients. If patients provide their consent and are eligible, they will undergo SECD administration for cancer screening in their primary care clinic. The study will evaluate the feasibility of use of this diagnostic tool in rural primary care settings, patient acceptability of screening for esophageal cancer via SECD in their primary care clinics, and where there are positive cases, the efficacy of diagnostic and treatment pathways to transitioning patients to tertiary centers for full diagnostic workup.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Willing and able to comply with the protocol
- •Live in a rural area
- •Chronic GERD Dx
- •3 or more of the following risk factors: Male, age >50 years White race Tobacco smoking Obesity Family history of BE or EAC in a first-degree relative
排除标准
- 未提供
研究组 & 干预措施
Patients with suspected Barrett's Esophagus or at risk for esophageal cancer
Patients who receive primary care in a rural settings and are in need of screening for Barrett's Esophagus or esophageal cancer.
干预措施: Screening with swallowable esophageal cell-collection devices (SECD) (Device)
结局指标
主要结局
Feasibility of the use of a SECD: Number of providers who indicate likelihood of using SECD
时间窗: 8 months
Feasibility of screening for esophageal cancer via SECD in rural primary care settings will be measured by data collected from Provider Post-Inservice Questionnaire, which includes, Indication of provider likelihood of using SECD as a screening tool.
Feasibility of the use of SECD: Number of providers who indicate willingness to be trained and train clinic staff
时间窗: 8 months
Feasibility of screening for esophageal cancer via SECD in rural primary care settings will be measured by data collected from Provider Post-Inservice Questionnaire, which includes, Indication of provider willingness to be trained and train clinic staff in SECD administration.
Feasibility of the use of SECD: Number of referrals
时间窗: 8 months
Feasibility of screening for esophageal cancer via SECD in rural primary care settings will be measured by data collected from number of provider referrals received for the study.
Feasibility of the use of SECD: Number enrolled
时间窗: 8 months
Feasibility of screening for esophageal cancer via SECD in rural primary care settings will be measured by data collected from number of patients enrolled.
Patient acceptability: Number of interested patients who schedule an appointment to be screened
时间窗: 8 months
Assess patient acceptability of using a SECD for screening in rural primary care settings vs tertiary care centers Acceptability will be measured by the number of interested patients who schedule an appointment to be screened via the SECD and the number of patients who come to their appointments. As well as patients who are interested in being screened via SECD at other care centers where it is offered.
Patient acceptability: Number of patients who come to their appointments
时间窗: 8 months
Assess patient acceptability of using a SECD for screening in rural primary care settings vs tertiary care centers Acceptability will be measured by the number of interested patients who schedule an appointment to be screened via the SECD and the number of patients who come to their appointments. As well as patients who are interested in being screened via SECD at other care centers where it is offered.
Patient acceptability: Number of patients interested in being screened via SECD at other care centers
时间窗: 8 months
Assess patient acceptability of using a SECD for screening in rural primary care settings vs tertiary care centers Acceptability will be measured by the number of interested patients who schedule an appointment to be screened via the SECD and the number of patients who come to their appointments. As well as patients who are interested in being screened via SECD at other care centers where it is offered.
次要结局
- Access: time to full diagnostic work up for patients with positive SECD results(8 months)
研究者
Fouad Otaki
Principal Investigator
OHSU Knight Cancer Institute