跳至主要内容
临床试验/NCT02194959
NCT02194959已完成不适用

Training African American Peers as Patient Navigators for Colon Cancer Screening

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2011年7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
800
试验地点
1
主要终点
Colonoscopy completion

研究概览

简要总结

Cancer health disparities related to race and ethnicity are among the most serious problems facing the US health care system. A recent institute of medicine report stated that such disparities are seen at every level of health care, from prevention to treatment and follow-up. This problem is acutely evident in the figures for colorectal cancer (CRC) among African Americans. According to the American cancer society, African Americans have the highest CRC incidence and mortality of any ethnic/racial group. Indeed, CRC incidence and mortality are 15% and 43% higher among African Americans than whites, respectively. These disparities could be effectively reduced through greater African American participation in CRC screening and early detection. More importantly, due to the preponderance of CRC in African Americans beyond the reach of the flexible sigmoidoscopy (1), increased adherence to colonoscopy among African Americans will save lives. Although there is clear evidence that providing patients with someone to help them manage/navigate the health care system (i.e., patient navigation (PN)) is effective in helping them to complete cancer screening, very few hospitals provide PN for colonoscopy. The vast majority of hospitals in NYC are unable to provide PN for patients for whom colonoscopy is recommended, in large part because of the costs associated with professional-led PN. This project seeks to address this serious public health problem by investigating the success of training African Americans who have undergone colonoscopy to serve as volunteer peer patient navigators to encourage others from their community to complete CRC screening via colonoscopy.

详细描述

The overall goal of the study was to reduce CRC morbidity and mortality by increasing African American participation in colonoscopy. This was done by development and implementation of a training program for Peer Patient Navigation (PPN) to increase participation of African Americans in colonoscopy.

The primary care physician referred all participants and introduced the study to the patient. The physician will then introduced the patient to the Research Assistant/Recruiter immediately following the medical visit during which a CRC screening colonoscopy was recommended. The Research Assistant/Recruiter reviewed the study and asked potential participants if they were interested; if so, the candidate's eligibility was determined. If these criteria were met and the patient wanted to be in the study, informed consent and HIPAA was reviewed and obtained. If the patient wanted to think about his/her decision, informed consent was obtained at a later date.

Patients were referred and scheduled for screening colonoscopy as part of standard of care. Both groups received 3 intervention phone calls from their assigned navigators, 1) to schedule the colonoscopy, 2) a call 2 weeks before the procedure and, 3) a third call three days before the procedure.

For research purposes, participants were randomized to one of two kinds of patient navigation:

  1. Standard patient navigation receiving care that they would normally receive if they were not participating in the study with navigation from the GI staff, and three phone calls involved scheduling and reminding the participant about their colonoscopy appointment.
  2. Peer Patient Navigation (PPN): Participants were assisted by African American peers who have undergone colonoscopy, and were able to discuss, first-hand, their personal experience undergoing colonoscopy and describe how they coped effectively with the procedure.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be self-identified as African-American
  • Referral from a primary care physician for colonoscopy
  • Agree to undergo colonoscopy at a participating hospital
  • Be at least 50 years of age or older
  • Have telephone service
  • Be able to provide informed consent in English

排除标准

  • Personal or family history (1st degree relative) of colon cancer
  • Personal history of any chronic GI disorder (i.e., irritable bowel syndrome, colitis)

结局指标

主要结局

Colonoscopy completion

时间窗: up to 6 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 (1)

Loading locations...

相似试验