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临床试验/NCT01052922
NCT01052922已完成不适用

Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement

Kaiser Permanente2 个研究点 分布在 1 个国家目标入组 2,260 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,260
试验地点
2
主要终点
Adherence to FOBT test kit

研究概览

简要总结

Ancillary Aim #1 We will evaluate intervention effects by comparing binary outcomes for screening (yes/no) in the primary SOS study. In this aim, we propose to calculate actual screening rates by use of time-to-event analyses (also known as survival analysis). The outcome variable of interest is the first time since randomization to have CRCS, either based on FOBT, FS, or CS. Knowing screening rates will not only enable us to make comparisons between groups, but also over time.

Ancillary Aims #2 and #3 We will recruit additional participants for two ancillary study aims. First, we will enroll patients age 50-74 years using the same criteria as for the primary SOS study, which includes neither history of colorectal cancer nor evidence of life-limiting disease. Participants who return the questionnaire, consent and considered eligible will be randomized to receive one of three different at-home fecal test kits. The kits will be returned to the GH centralized laboratory, and participants will be informed about lab results using standard GH pathways. Participants who have a test-positive will receive a series of two follow-up surveys (first at 1-2 weeks post result and second at 4-months post result). A comparison group of test-negative results will be matched based on selected criteria, and this group will also receive the follow-up surveys. Participants at both time intervals who do not return the survey via mail will be called and if available, administered the questionnaire via phone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
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

入选标准

  • Not up to date on CRCS
  • Continuously enrolled in GHC for 24 months
  • Expected to continue to be enrolled at GHC for 24 months

排除标准

  • Known high risk for CRC
  • History of CRC
  • History of inflammatory bowel disease
  • Current anticoagulation therapy
  • Organ failure
  • Serious illness
  • Debilitating disease
  • Nursing home resident.

结局指标

主要结局

Adherence to FOBT test kit

时间窗: 1-2 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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