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临床试验/NCT04607291
NCT04607291已完成1 期

Increasing Access and Developing Predictors for Colorectal Cancer Screening for Minority and Medicaid Clients

Roswell Park Cancer Institute1 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2019年9月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
183
试验地点
1
主要终点
Change in Screening Metrics

研究概览

简要总结

This phase I study investigates how well a health service program called Witness CARES Services works in increasing access and adherence to colorectal cancer screening in patients who have not undergone a colorectal screening in the past year. Providing patients with navigational and screening services via Witness CARES Services may improve access to and adherence levels of colorectal screening.

详细描述

PRIMARY OBJECTIVES:

I. Test the feasibility of Witness CARES (WC) Services to achieve colorectal carcinoma (CRC) screening for non-adherent Medicaid clients.

II. Develop an algorithm for predicting CRC screening outcomes following intervention services.

OUTLINE:

Patients who are not prepared for a colonoscopy or stool test receive educational materials, messages, and videos electronically or by mail with information about colorectal screening and are followed up by phone within 2 weeks. Patients desiring colonoscopy receive navigator assistance with obtaining the screening (e.g.,determining gastrointestinal doctor, scheduling appointment, prep materials and process, transportation, escort). Patients desiring a stool test receive navigator assistance by facilitating fecal tests.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Participants who are non-adherent to CRC screening over the past year (i.e., no stool testing in past 11 months or colonoscopy for over 9 years)
  • •Medicaid or Medicaid/Medicare subscribers
  • •Uninsured patients may be included from Mercy Comprehensive Care Center (MCCC), but will only be eligible for services to obtain fecal immunochemical tests (FIT) through the New York State (NYS) Cancer Services Program

排除标准

  • •Any participants from the lists of gaps in care clients from insurance or primary care practices who report having had a colonoscopy in the past 9 years (or having positive findings such as polyps, 5 years) or having completed some type of fecal test for CRC will be excluded
  • •Participants under 50 will be excluded unless they have been deemed high risk by their physician, and have a prescription for CRC screening
  • •Participants symptomatic for CRC will be excluded from the study

研究组 & 干预措施

Health services research (Witness CARES services) Intervention

Experimental

Patients who are not prepared for a colonoscopy or stool test receive educational materials, messages, and videos electronically or by mail with information about colorectal screening and are followed up by phone within 2 weeks. Patients desiring colonoscopy, receive navigators assistance with obtaining the screening (e.g.,determining gastrointestinal doctor, scheduling appointment, prep materials and process, transportation, escort). Patients desiring a stool test, receive navigators assistance by facilitating fecal tests.

干预措施: Community Health Service (Other)

Health services research (Witness CARES services) Intervention

Experimental

Patients who are not prepared for a colonoscopy or stool test receive educational materials, messages, and videos electronically or by mail with information about colorectal screening and are followed up by phone within 2 weeks. Patients desiring colonoscopy, receive navigators assistance with obtaining the screening (e.g.,determining gastrointestinal doctor, scheduling appointment, prep materials and process, transportation, escort). Patients desiring a stool test, receive navigators assistance by facilitating fecal tests.

干预措施: Survey Administration (Other)

结局指标

主要结局

Change in Screening Metrics

时间窗: Up to 12 months

After CRC screening, satisfaction surveys will be conducted in order to assess the services of the Witness Cares Program. Below are responses to basic follow-up questions.

Model Development for Prediction of Intent and Colorectal Cancer (CRC) Screening Behaviors

时间窗: Up to 12 months

A telephone assessment of 118 self reported questions will be conducted in order to assess what factors are associated with CRC screening. The outcome of interest is CRC screening (colonoscopy or fecal immunochemical testing (FIT) test), which is treated as a binary outcome. The potential predictors include basic demographic characteristics as well as the survey sub-scales (based on the 118 self-reported questions).

次要结局

  • Prediction of Which CRC Screening Test is Most Acceptable(Up to 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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