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临床试验/NCT05447923
NCT05447923招募中不适用

Colorectal Cancer Screening in Black and Underserved Communities in the Phoenix Metro Area: Addressing Disparities in Cancer Prevention

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2022年5月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
Mayo Clinic
入组人数
450
试验地点
2
主要终点
Colorectal cancer disparities seen in people of color and minority populations

研究概览

简要总结

This clinical trial studies disparities involving colorectal cancer prevention and screening in Black and underserved communities in the Phoenix metropolitan area. The Black community is disproportionately impacted by colorectal cancer, with the highest rate of any racial/ethnic group in the United States. There are complex reasons behind these disparities, largely related to socioeconomic factors and healthcare access. Providing access to free, home-based fecal immunochemical testing (FIT), colorectal screening education, and appropriate follow-up to predominantly Black community-based organizations and underserved communities may help to close this gap.

详细描述

PRIMARY OBJECTIVES:

I. To evaluate patient navigation to address colorectal cancer disparities seen in people of color, minority populations, and establish an ongoing colorectal cancer screening outreach program for this community in Phoenix.

OUTLINE:

Participants receive free FIT tests in conjunction with education on colorectal cancer screening. Participants undergo self-collect FIT and mail the sample to Mayo Clinic Lab for processing. Participants also complete a questionnaire about colorectal cancer screening and healthcare. Participants receive FIT test results through Mayo Clinic nursing support and participants with a positive test are followed up by a patient navigator to discuss next steps and consultation with a gastroenterologist to review their results.

After completion of screening, participants with a positive FIT test are followed up at 2 and 4 weeks after initial outreach to assure participants have received adequate follow up.

研究设计

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

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 45 years of age or older
  • No prior history of colorectal cancer or colon polyps
  • No first-degree family history of colorectal cancer who were diagnosed under age 60
  • No current gastrointestinal (GI) or rectal symptoms (such as rectal bleeding)
  • Have not undergone a colonoscopy in the last 5 years
  • Have not had a fecal immunochemical test (FIT) test within the last year
  • Participants that attend 4 predominantly African American churches within the Phoenix Community and extend the study opportunity as feasible to other underserved communities in the Phoenix Metro area

排除标准

  • 未提供

研究组 & 干预措施

Screening (FIT, education, questionnaire, patient navigation)

Experimental

Participants receive free FIT tests in conjunction with education on colorectal cancer screening. Participants undergo self-collect FIT and mail the sample to Mayo Clinic Lab for processing. Participants also complete a questionnaire about colorectal cancer screening and healthcare. Participants receive FIT test results through Mayo Clinic nursing support and participants with a positive test are followed up by a patient navigator to discuss next steps and consultation with a gastroenterologist to review their results.

干预措施: Patient Navigation (Behavioral)

Screening (FIT, education, questionnaire, patient navigation)

Experimental

Participants receive free FIT tests in conjunction with education on colorectal cancer screening. Participants undergo self-collect FIT and mail the sample to Mayo Clinic Lab for processing. Participants also complete a questionnaire about colorectal cancer screening and healthcare. Participants receive FIT test results through Mayo Clinic nursing support and participants with a positive test are followed up by a patient navigator to discuss next steps and consultation with a gastroenterologist to review their results.

干预措施: Educational Intervention (Other)

Screening (FIT, education, questionnaire, patient navigation)

Experimental

Participants receive free FIT tests in conjunction with education on colorectal cancer screening. Participants undergo self-collect FIT and mail the sample to Mayo Clinic Lab for processing. Participants also complete a questionnaire about colorectal cancer screening and healthcare. Participants receive FIT test results through Mayo Clinic nursing support and participants with a positive test are followed up by a patient navigator to discuss next steps and consultation with a gastroenterologist to review their results.

干预措施: Fecal Immunochemical Test (Other)

Screening (FIT, education, questionnaire, patient navigation)

Experimental

Participants receive free FIT tests in conjunction with education on colorectal cancer screening. Participants undergo self-collect FIT and mail the sample to Mayo Clinic Lab for processing. Participants also complete a questionnaire about colorectal cancer screening and healthcare. Participants receive FIT test results through Mayo Clinic nursing support and participants with a positive test are followed up by a patient navigator to discuss next steps and consultation with a gastroenterologist to review their results.

干预措施: Questionnaire Administration (Other)

结局指标

主要结局

Colorectal cancer disparities seen in people of color and minority populations

时间窗: Up to study completion, up to 30 days

Evaluate patient navigation to address colorectal cancer disparities seen in people of color, minority populations, and establish an ongoing colorectal cancer screening outreach program.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Sponsor

研究点 (2)

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