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临床试验/NCT07796334
NCT07796334尚未招募不适用

Colon Health Champion Program

Virginia Commonwealth University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2026年9月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
29
试验地点
1
主要终点
Determine feasibility of Colon Health Champions (CHC)-Successful Recruitment

研究概览

简要总结

This is a single arm-proof-of-concept trial. The primary goal of this trial is to assess the feasibility and acceptability of the Colon Health Champion Program

详细描述

Participants in the Colon Health Champion Program will join in a small group discussion and watch videos to learn about colon cancer and why it is important to get checked (screened). They will fill out surveys before and after the meeting, and again one month later. At the end of the discussion, participants may be offered a FIT test to check for colon cancer.

研究设计

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

入排标准

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

入选标准

  • Adults aged (45-75 years old) who reside in target communities.
  • Ability to speak, write, and comprehend English language
  • Additional for trial participants only (not champions): Participants will include adults who are at average risk of colorectal cancer (CRC) and due for routine CRC screening.

排除标准

  • Planning to move from the area within the study period
  • Cognitive impairment that would preclude informed consent or completion of study measures
  • Additional for Trial Participants only (not Champions):
  • At elevated risk of CRC, defined as having one or more of the following:
  • Personal history of CRC, adenomatous polyps, or inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
  • Strong family history of CRC, defined as having one first-degree relative diagnosed at age 59 or younger or two or more first-degree relatives who have had CRC
  • Known hereditary CRC syndromes (e.g., Lynch syndrome or familial adenomatous polyposis [FAP])
  • Currently experiencing potential colorectal symptoms, including:
  • Blood in stool or rectal bleeding
  • Persistent changes in bowel habits (e.g., constipation or changes in stool shape lasting more than two weeks)
  • Unintended or unexplained weight loss
  • Severe fatigue or anemia
  • Currently up-to-date with CRC screening, defined as having received any of the following tests:
  • Colonoscopy within the last ten years
  • FIT within the last year
  • FIT +DNA within the last three years

研究组 & 干预措施

Proof-of-concept trial to assess the Colon Health Champion Program

Experimental

Participants will attend an in-person small group discussion. The discussion will teach participants about colon cancer and why it is important to get checked (screened).

干预措施: Intervention Arm: Colon Health Champions (CHC) Program (Behavioral)

结局指标

主要结局

Determine feasibility of Colon Health Champions (CHC)-Successful Recruitment

时间窗: Day the last participant is enrolled, and the protocol closes to accrual, (estimated enrollment duration is up to 12 months)

Meeting participant enrollment within the recruitment window

Determine feasibility of Colon Health Champions (CHC) Intervention - Participation

时间窗: 1 month following intervention

Achieving \>/=70% participation retention at the 1-month follow-up assessment.

次要结局

  • Determine Acceptability of Colon Health Champions (CHC)(Immediately following intervention (post-intervention))
  • Determine Fidelity of Colon Health Champions (CHC)(Immediately following intervention (post-intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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