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临床试验/NCT06085560
NCT06085560Enrolling By Invitation不适用

Choice, Implementation Intentions and Colorectal Cancer Screening

Michigan State University2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2023年7月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
600
试验地点
2
主要终点
Colorectal Cancer Screening Modality Request Rates

研究概览

简要总结

The goal of this study is to improve use of colorectal cancer screening among screening eligible African Americans who are served by Federally Qualified Health Centers in Michigan. The main questions it aims to answer are:

  • To what extent to individual prefer and select to complete screening with colonoscopy versus stool-based (FIT Kit or sDNA) options?
  • Can full completion of (i.e. follow-through with) screening with a selected modality be enhanced by delivery of a culturally targeted intervention?

Participants will learn about colonoscopy, FIT Kit and sDNA as recommended and widely used screening options. Participants will select a modality to complete their own screening with. Participants will then be randomized to one of three arms (usual care, standard intervention, culturally targeted intervention). Researchers will compare the extent to which intervention arms enhance completion rates across each of the three screening modalities.

详细描述

Background: African-Americans are more likely than other racial groups to develop and die from colorectal cancer (CRC). These disparities are largely due to lower rates of CRC detection among African-Americans. At-home CRC screening using a recommended screening tool - including fecal immunochemical testing (FIT Kit) and stool DNA testing (sDNA) ¬- could aid in reducing disparities. Yet, at-home screening remains underutilized, and little is known about preferences for specific at-home screening alternatives, despite that options present tradeoffs that likely influence uptake. Another challenge, including among African Americans, is that at-home screening suffers from low conversion - full completion of screening by individuals who are issued at-home screening kits. Implementation intentions may be an effective psychological tool for overcoming low conversion among African Americans.

Objective/Hypothesis: This study proposes to evaluate preference for and conversion rates associated with colonoscopy, FIT Kit and sDNA testing among low income Africans Americans, and will evaluate use of implementation intentions to promote uptake and conversion across these screening modalities.

Specific Aims: (1) To identify and compare preferences for colonoscopy versus annual FIT KIT testing versus stool DNA testing once every three years in a community sample of CRC screening-eligible African-Americans; (2) To identify and compare conversion of at-home CRC screening over three years among participants who elect to complete FIT Kit versus stool DNA testing for at-home CRC screening; (3) To determine the effectiveness of utilizing culturally targeted Implementation Intentions to promote conversion of colonoscopy and at-home CRC screening in screening eligible African-Americans.

Study design: In collaboration with clinical and community experts, the investigators will develop video materials to educate CRC screening eligible individuals about colonoscopy FIT Kit and sDNA as options for at-home CRC screening. In partnership with two Federally Qualified Health Center - one in Detroit, MI and one in Flint, MI - the investigators will provide access to these screening options and evaluate preferences for and conversion associated with each screening modality in a sample of screening eligible low-income African Americans. To consider strategies for enhancing conversion, the investigators will also evaluate a culturally-targeted approach to implementation intentions for use with CRC screening.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Screening
盲法
Single (Participant)

盲法说明

Participants will be unaware of their assignment to usual care vs. intervention conditions

入排标准

年龄范围
45 Years 至 72 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • African American, ages 45-72, Medicaid or Medicare or private insurance, current health center patient, eligible for CRC screening (Colonoscopy more than 10 years ago, Sigmoidoscopy more than 5 years ago, FOB test more than 1 year ago, FIT kit more than 1 year ago, sDNA test more than 3 years ago, Never been screened).

排除标准

  • All who do not meet inclusion criteria.

研究组 & 干预措施

Implementation Intention Intervention: Culturally-Targeted Message

Experimental

Participants selecting a colorectal cancer screening will receive culturally-targeted implementation intention messages in addition to the "usual care" from the FQHC.

干预措施: Implementation Intention Intervention: Culturally-Targeted Message (Behavioral)

Usual Care Message

Active Comparator

Participants selecting a colorectal cancer screening will receive "usual care" from the FQHC.

干预措施: Usual Care Message (Behavioral)

Implementation Intention Intervention: Standard Message

Active Comparator

Participants selecting a colorectal cancer screening will receive implementation intention messages in addition to the "usual care" from the FQHC.

干预措施: Implementation Intention Intervention: Standard Message (Behavioral)

结局指标

主要结局

Colorectal Cancer Screening Modality Request Rates

时间窗: up to 2 weeks

Frequency (percentage) with which colonoscopy versus FIT Kit versus sDNA kit versus no screening are selected.

Colorectal Cancer Screening Completion Rate

时间窗: up to 6 months

Frequency (percentage of time) that chosen screening method is fully completed.

Theory of Planned Behavior Colorectal Cancer Screening Outcomes

时间窗: collected immediately, up to 1 hour

Self-report measures of colorectal cancer screening attitudes, norms, perceived control, intentions to be screened are each adapted from published research (Lucas et al., 2021). These items are constructed following recommended procedures to ensure construct validity and adequate behavioral specificity (Fishbein \& Ajzen, 2011). All items use Likert-type scales that range from 1 (strongly agree) to 7 (strongly disagree).

Anticipatory Racism

时间窗: collected immediately, up to 1 hour

Adapted from published research (Lucas et al., 2021), all participants respond to questions that asked whether they believe racism would impact the benefits they could experience from obtaining colorectal cancer screening. Participants will then respond to three questions that ask, "In some way, my obtaining CRC screening would be impacted by racism," "Racism would undermine the value of CRC screening for me." and "Racism would negatively impact the accuracy of my CRC screening. Responses are collected using a 7-point Likert-type scale that ranged from 1 (strongly agree) to 7 (strongly disagree).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Todd Lucas

C.S. Mott Endowed Professor

Michigan State University

研究点 (2)

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