Comparative Effectiveness of Interventions to Improve Screening Among Rural Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 985
- 试验地点
- 4
- 主要终点
- Percentage of Participants Who Received All Needed Screening and Any Needed Screening Across the Three Randomized Arms
研究概览
简要总结
This randomized clinical trial studies how well a tailored interactive digital versatile disc (DVD) with or without patient navigation works in improving screening rates in rural women for breast cancer, cervical cancer or colorectal cancer. A tailored interactive DVD and patient navigation may help rural women to learn more about cancer screening and to better understand the results.
详细描述
PRIMARY OBJECTIVES:
I. Compare the effectiveness of a tailored and interactive DVD (TIDVD) versus (vs.) TIDVD + telephone-based patient navigation (PN) intervention (TIDVD + PN) vs. usual care (UC), to increase guideline-based cancer screening rates at 12 months post randomization for breast cancer (BC), cervical cancer (CC), and colorectal cancer (CRC) among 1058 women age 50 to 74 living in rural northwest Ohio and northeast Indiana.
II. Compare the cost effectiveness of the TIDVD and the TIDVD + PN intervention vs. UC, for adherence to each screening outcome or combination of screening tests.
OUTLINE: Patients are randomized to 1 of 3 arms.
Arm I: Patients watch a tailored interactive DVD program and answer questions posed by the DVD program.
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 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Be non-adherent to one or more recommended screenings for BC, CC, or CRC by Medical Record Review (MRR)
- •Reside in one of 32 rural counties in Indiana (IN) or Ohio (OH)
- •Provide informed consent
- •Able to speak/read English
- •Have access to a DVD player or computer that can play DVDs
排除标准
- •Have a personal or family history of any hereditary/genetic cancer syndrome such as BRCA1 and BRCA2 polymorphisms, hereditary nonpolyposis colon cancer, or familial adenomatous polyposis
- •Have a personal history of inflammatory bowel disease (Crohn's disease or colitis), colon polyps, or a history of cancer except non-melanoma skin cancer
- •Have a first degree relative with a history of breast or colorectal cancer
- •Plan to move outside of the country within the next year
- •Reside in a nursing home or other institution
- •Are pregnant or intend to become pregnant during the study period
结局指标
主要结局
Percentage of Participants Who Received All Needed Screening and Any Needed Screening Across the Three Randomized Arms
时间窗: Up to 12 months
Will be tested initially with pair-wise chi-square tests. Binary logistic regression analysis will be used to compare the two interventions and the UC group on the binary dependent variable (adherence), while adjusting for any potentially confounding covariates. The models will be controlled for any demographic covariate (e.g., age, education) for which the randomized groups differ significantly at baseline using a liberal significance level of 0.20 to achieve conservative adjustment. As a sensitivity analysis, multiple imputation will be used to impute the adherence outcome for participants.
次要结局
- Cost Effectiveness of Each Intervention(Up to 12 months)
- Cost of the Interventions(Up to 12 months)
研究者
Electra Paskett
Principal Investigator
Ohio State University Comprehensive Cancer Center