The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,711
- 试验地点
- 4
- 主要终点
- Increase in colorectal cancer screening rate of the 5 tested invitation approaches.
研究概览
简要总结
Participants will be mailed an invitation to complete CRC screening along with a fecal immunochemical test (FIT) kit, containing a 1-sample "Polymedco Over the Counter (OC) Sensor FIT", simplified English/Spanish instructions on performing the test, educational information about colorectal cancer screening and a return mailer with prepaid postage.
Processes that will be used to promote screening completion include automated and "live" phone call reminders to encourage completion of FIT testing.
Participants will be randomly assigned to 1 of 5 interventions across 3 conditions, described below:
- Condition 1 (Standard Intervention):
- Branch I: Participants assigned to the control condition will receive a FIT kit and the standard invitation letter to participate in free screening.
- Condition 2 (Time Guideline):
- Branch II: Participants will receive a FIT kit and invitation letter to participate in free screening with a 1-week time restriction.
- Branch III: Participants will receive a FIT kit and invitation letter to participate in free screening with a 3-week time restriction.
- Condition 3 (Time Guideline + Incentive):
- Branch IV: Participants will receive a FIT kit and invitation letter to participate in free screening requesting they return the kit within 1-week for a "higher" monetary incentive or within 3 weeks for a "lower" (half of the higher) monetary incentive.
- Branch V: Participants will receive a FIT kit and invitation letter to participate in free screening requesting they return the kit within 1-week for a "higher" (same as lower in Branch IV) monetary incentive or within 3 weeks for a "lower" (half of the higher) monetary incentive.
Participants with a normal test result will receive a personal letter confirming this with invitations to complete a repeat screening in subsequent year(s). Participants receiving an abnormal FIT result will be navigated to complete a diagnostic colonoscopy.
Participants continuing in the screening program in subsequent years will receive letters emphasizing the importance of repeat screening to prevent adverse CRC outcomes.
详细描述
Eligible subjects will be identified from John Peter Smith (JPS) Health Network. A preliminary aggregate report suggests 10,000 patients may be identified for screening evaluation.
Data compilation and management will be centralized at the University of Texas (UT) Southwestern Medical Center - Moncrief Cancer Institute (MCI) using John Peter Smith Health Network administrative claims data to assess screening rates while individually identifying patients not up-to-date with screening. Data will be queried to identify all 50-74 year olds who are potentially eligible for program inclusion.
Data sources will include:
- The existing database of John Peter Smith patients who are part of a previous CRC screening study (STU 082012-086)
- Administrative and electronic medical record databases from JPS
Patient datasets provided by John Peter Smith Health Network will be obtained through a data use agreement. Inclusion/exclusion criteria will be applied prior to data transfer. The dataset will be transferred through secure, data encrypted transfer systems data encrypted universal serial bus (USB) drives.
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
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Uninsured or Underinsured
- •English or Spanish speaking
- •No history of colon cancer or colon resection
- •No history of inflammatory bowel disease
- •Colonoscopy not completed in the last 10 years
- •Sigmoidoscopy not completed in the last 5 years
- •Fecal Occult Blood Test (FOBT) or fecal immunochemical test (FIT) not completed in the last year
- •Complete contact information on file
- •Not incarcerated or homeless
排除标准
- •Under 50 or over 74 years of age
- •Insured but not underinsured
- •Other than English or Spanish speaking
- •History of colon cancer or colon resection
- •History of inflammatory bowel disease
- •Colonoscopy completed within the last 10 years
- •Sigmoidoscopy completed within the last 5 years
- •FOBT or FIT screening completed within the last year
- •Incomplete contact information (i.e., no address or phone number on file)
- •Incarcerated or homeless
结局指标
主要结局
Increase in colorectal cancer screening rate of the 5 tested invitation approaches.
时间窗: 24 days [3 week + 3 days for mailing] from time of mailed invitation
Primary analysis will be proportion of participants returning their kit within 24 days of mailing. We a priori computed sample size required to have 80% power to detect at least an 8% absolute increase in screening between each branch. We planned for 10 pairwise comparisons with a two-sided 0.005 (=0.05/10) significance level and Bonferroni correction. Estimated return rate for the control was 36.5%. Based on these parameters, we estimate requiring at least 1,026 individuals per group. To maximize sample receiving outreach, the final sample will randomize all eligible patients and is expected to be larger than 1,026 per group.
次要结局
未报告次要终点
研究者
Keith Argenbright
Professor of Medicine
University of Texas Southwestern Medical Center