Comparing Interventions to Increase Colorectal Cancer Screening in Low-Income and Minority Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 371
- 试验地点
- 2
- 主要终点
- Participants Completing CRC Screening Per Electronic Medical Record Documentation
研究概览
简要总结
The purpose of this study is to test different approaches to help people understand the purpose of colorectal cancer (CRC) screening, two screening test options available, and the barriers to screening so they can make informed decisions about CRC screening. Participants will be randomly assigned to one of three groups: (1) one group will receive a tailored digital video disc (DVD) in the mail; (2) another group will receive the mailed DVD plus telephone calls from a patient navigator; and (3) the third group will receive the care normally provided by the healthcare system's endoscopy department.
The investigators hypothesize the following: (1) participants who receive the tailored DVD plus the patient navigation intervention will have higher rates of CRC screening with the fecal immunochemical test (FIT), colonoscopy, or either screening test compared to those who receive the tailored DVD alone; (2) participants who receive either intervention (DVD only or DVD plus patient navigation) will have higher rates of CRC screening with FIT, colonoscopy, or either screening test than those who receive usual care; and (3) participants who receive either intervention who complete colonoscopy will have better quality of bowel preparation, less anxiety about the procedure, and greater satisfaction with the colonoscopy experience than those who receive usual care.
详细描述
Colorectal cancer (CRC) often can be prevented through regular screening and although multiple screening tests are available, colonoscopy is often the only screening test offered to patients. Unfortunately, up to half of people in some hospitals who receive a recommendation and are scheduled for colonoscopy do not complete the test. Reasons for not completing colonoscopy include lack of awareness of the need for, and benefits of, screening, fear of pain, fear of finding cancer, unpleasantness of the bowel preparation, cost, transportation issues, and the unwillingness to undergo an invasive test in the absence of symptoms. The process of bowel cleansing is one of the most challenging aspects of having a colonoscopy. Interventions that improve patients' knowledge about CRC screening, including test options other than colonoscopy, enhance access, improve skills needed to complete CRC screening, and reduce barriers will lead to greater numbers of people being screened. Patient navigation and computer tailored interventions have been shown to be effective approaches to increase CRC and other cancer screening but there is no evidence of their comparative effectiveness. The purpose of this study is to compare two health system-based interventions, with one another and with usual care, to increase completion rates among a diverse sample of patients. The investigators will enroll an ethnically diverse group of 450 men and women aged 50-75,or aged 45-75 if African American, who are at average risk for CRC and were referred and scheduled for colonoscopy at one endoscopy department but canceled or did not attend their scheduled appointment. Participants will be randomized to receive: (1) a mailed tailored digital video disc (DVD) alone; 2) the mailed tailored DVD plus a telephone-based Patient Navigator; or 3) usual care. Data will be collected at baseline, at 6 months and at 9 months post-baseline. Interviews to assess receipt, viewing, and satisfaction with the tailored DVD will be conducted 2 weeks after mailing. Satisfaction with the patient navigator will be assessed at 6 months. Multivariable logistic regression analyses will be used to test the interventions' effects on CRC screening test completion and, for those who complete colonoscopy, quality of bowel preparation. The investigators will also examine whether these interventions change knowledge about CRC and screening as well as health beliefs (perceived risk, perceived benefits, barriers, and self-efficacy) about screening. From this study, the investigators will learn how effective these two standardized, easy to disseminate health system-based interventions are compared to each other and to usual care. If the interventions are found to be equally effective, or differentially effective for different subgroups of patients, healthcare systems may consider implementing one or both of these interventions in their settings.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Referred for a screening colonoscopy that was not done (i.e, canceled or no show)
排除标准
- •Unable to speak, read, and write English
- •Personal history of CRC or polyps
- •Personal history of conditions that place participants at high risk for CRC such as ulcerative colitis, Crohn's disease, or known hereditary syndromes such as familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer
- •Family history of CRC which increases the participant's risk for CRC
- •Advised by a health care provider to not have a colonoscopy due to the participant's health
- •Speech impairment
- •Hearing impairment
- •Cognitive impairment
- •Vision impairment
研究组 & 干预措施
Tailored DVD
Tailored digital video disc (DVD)
干预措施: Tailored DVD (Behavioral)
Tailored DVD + Patient Navigation
Tailored digital video disc (DVD) plus Patient Navigation by a population health nurse in the healthcare system
干预措施: Tailored DVD (Behavioral)
Tailored DVD + Patient Navigation
Tailored digital video disc (DVD) plus Patient Navigation by a population health nurse in the healthcare system
干预措施: Patient Navigation (Behavioral)
Usual Care
Care normally provided by a nurse in the endoscopy department of the healthcare system
结局指标
主要结局
Participants Completing CRC Screening Per Electronic Medical Record Documentation
时间窗: 12 months post-baseline interview
Number of participants completing CRC screening by any test (defined as colonoscopy or FIT) is measured by electronic medical record review. Dates that participants had a colonoscopy and dates of FIT analysis are extracted from the electronic medical record.
次要结局
- Change in Perceived Barriers to CRC Screening by Colonoscopy(6 months post-baseline interview)
- Change in Perceived Self-Efficacy for CRC Screening by Colonoscopy(6 months post-baseline interview)
- Change in Perceived Benefits of CRC Screening by FIT(6 months post-baseline interview)
- Change in Perceived Barriers to CRC Screening by FIT(6 months post-baseline interview)
- Change in Perceived Self-Efficacy for CRC Screening by FIT(6 months post-baseline interview)
- Participants Completing Colonoscopy Per Electronic Medical Record Documentation(12 months post-baseline interview)
- Bowel Preparation Quality Rating Using Boston Bowel Preparation Scale(12 months post-baseline interview)
- Participants With Adequate Quality of Bowel Preparation Per Modified Aronchick Rating Scale(12 months post-baseline interview)
- Colonoscopy-Related Procedural Anxiety for Participants Completing a Colonoscopy(12 months post-baseline interview)
- Satisfaction With Colonoscopy Experience(12 months post-baseline interview)
- Participants Completing a Fecal Immunochemical Test (FIT) Per Electronic Medical Record Documentation(12 months post-baseline interview)
- Participants Who Self-Reported Completing CRC Screening(6-9 months post-baseline interview)
- Participants Who Self-Reported Completing a Colonoscopy(6-9 months post-baseline interview)
- Participants Who Self-Reported Completing a Fecal Immunochemical Test (FIT)(6-9 months post-baseline interview)
- Change in Knowledge of CRC and Screening(6 months post-baseline interview)
- Change in Perceived Risk for CRC(6 months post-baseline interview)
- Change in Colonoscopy-Related Procedural Anxiety Regardless of Whether or Not Participants Had a Colonoscopy(6 months post-baseline interview)
- Change in Perceived Benefits of CRC Screening by Colonoscopy(6 months post-baseline interview)
