Ohio Colorectal Cancer Prevention Initiative: Adherence to Colon Cancer Screening (ACCS) Project:Your Personal Prescription For Colorectal Cancer Screening.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,900
- 试验地点
- 1
- 主要终点
- Successfully following screening guidelines appropriate to the participant's risk profile
研究概览
简要总结
This randomized clinical trial studies website access or genetic counseling with or without patient navigators on adherence to colorectal cancer screening recommendations in patients with newly diagnosed colorectal cancer and their first degree relatives. Websites for colorectal cancer prevention and genetic counseling may be effective methods to help people learn about cancer screening. Patient navigators may improve adherence to colorectal cancer screening recommendations. It is not yet known whether website access or genetic counseling is more effective with or without patient navigators.
详细描述
PRIMARY OBJECTIVES:
I. Test the comparative-effectiveness of the interventions (i.e., website +/- navigator or genetic counseling +/- navigator) in a randomized controlled trial, using colorectal cancer (CRC) cases as the unit of randomization/analysis on adherence to individualized CRC screening recommendations.
SECONDARY OBJECTIVES:
I. Examine the cost effectiveness of the interventions, assessing the effect of the interventions on subgroups (i.e., Lynch syndrome positive vs. Lynch syndrome negative; probands vs. relatives; older vs. younger patients, etc), and barriers to adherence, as well as how the navigators resolve barriers.
II. Overscreening will be explored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newly diagnosed with colorectal adenocarcinoma at Ohio State University (OSU) (or a participating Ohio hospital) with sufficient tumor available to perform the microsatellite instability (MSI) test, regardless of age at diagnosis or family history
- •First-degree relatives of the cases who test positive for LS
- •First-degree relatives of the cases who test negative for LS
排除标准
- •Pregnant women
- •Prisoners
- •Individuals who are cognitively impaired
研究组 & 干预措施
Arm 1: website access only
There is no intervention with this arm. Completion of the website is part of enrollment.
Arm 2: patient navigator
The intervention consists of participants receiving the services of a patient navigator to address individual barriers to adhering to the "personal prescription" for colon and rectal cancer screening.
干预措施: Patient Navigator (Other)
Arm 3: genetic counseling
There is no intervention in this arm. Patients diagnosed as positive for Lynch Syndrome use genetic counseling to discuss medical and family history and genetic risk of CRC, including genetic factors such as DNA mismatch repair genes, autosomal dominant inheritance, cancer risks associated with LS, screening recommendations, and genetic testing. There is no intervention. This is standard care.
Arm 4:Gen. counselor & patient navigator
Participants diagnosed positive for Lynch syndrome use genetic counseling as in Arm 3 and in addition receive the services of a patient navigator to address individual barriers to adhering to the CRC screening recommendations.
干预措施: Patient Navigator (Other)
结局指标
主要结局
Successfully following screening guidelines appropriate to the participant's risk profile
时间窗: Up to 14 months
For participants who are within the recommended guidelines, success would be defined as receiving no further screening. For those outside of the recommended guidelines, success would entail receiving a screening test. The outcome will combine medical record review and self-report by using medical record review when available and self-report otherwise. Evaluations will use a generalized estimating equations (GEE) approach with empirical sandwich variance estimators.
次要结局
- Cost effectiveness of the interventions(Up to 14 months)
研究者
Electra Paskett
Principal Investigator
Ohio State University Comprehensive Cancer Center