Addressing Colorectal Cancer in South Florida Firefighters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 646
- 试验地点
- 2
- 主要终点
- Feasibility of Participants with Positive FIT Results Who Comply with Follow-up for Colonoscopy
研究概览
简要总结
The standard way of screening for colorectal cancer is to have a series of fecal blood tests, where a sample is taken from a participant's stool, or an endoscopic procedure performed by a doctor, where a camera is used to look inside the bowel. This research study will use a test performed by the participant. This test will look for changes in the stool that can identify if participants are at higher risk for cancer.
Another aim of this study is to better understand what firefighters and retired firefighters think about colorectal cancer and other health issues. This information will help us develop programs that may improve colorectal cancer outcomes in the firefighter community.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For this study, participation is open to active and retired firefighters:
- •≥ 40 and ≤ 65 years of age,
- •who work or worked in Florida Fire and Rescue departments and
- •report never having fecal occult blood test (FOBT) or sigmoidoscopy/colonoscopy in their life or only one FOBT in the past year, a sigmoidoscopy in the last 5 years or a colonoscopy in the last 10 years. The research assistant will assess eligibility using a brief screener that will be completed online via RedCAP.
- •For years 2 and 3 of the study, the investigators will enroll previously eligible participants who did not complete colorectal cancer (CRC) screening during year
- •The investigators will also enroll participants who completed fecal immunochemical test (FIT) with our study during year 1 and
- •They will be contacted via RedCAP and a follow up phone call at the 1 year mark of their previous screening. Based on national guidelines, FIT screening is suggested on a yearly basis. The eligibility criteria will be the same and participants will sign a revised informed consent form, stating that they understand that they are being re-consented for the same study.
- •Participants, ages 50-65 years old, meeting the above criteria who declined the offered standard-of-care FIT will then be offered the blood-based septin9 test 90 days from the initial offering. FDA guidelines require the participant to be at least 50 years old to participate in the septin9 blood collection. The blood based test will be collected by a nurse or certified phlebotomist in the community setting.
排除标准
- •Individuals, who have a personal history of CRC, inflammatory bowel disease (ie, Crohn disease involving the colon or ulcerative colitis) will be excluded from participation as these conditions increase the likelihood of positive test results not associated with the onset or recurrence of CRC disease. Additionally, individuals will be excluded if they are not physically capable of performing the FIT themselves.
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
结局指标
主要结局
Feasibility of Participants with Positive FIT Results Who Comply with Follow-up for Colonoscopy
时间窗: Up to 6 months
Feasibility will be measured as the percentage of participants with positive FIT results who comply with the necessary follow-up for colonoscopy. Criterion for success: 85% of all participants with positive FIT results comply with necessary follow up for colonoscopy.
Feasibility of Participants Completing FIT Screening Tool
时间窗: Up to 6 months
Feasibility will be measured as the percentage of eligible participants completing the FIT screening tool. Criterion for success: 65% of all eligible participants complete the FIT screening tool.
Feasibility of FIT Specimens Adequate for Lab Processing
时间窗: Up to 6 months
Feasibility will be measured as the percentage of FIT specimens collected from participants that are adequate for processing. Criterion for success: 95% of all FIT specimens are adequate for lab processing.
Acceptability of Participants Who Feel FIT is an Acceptable Method of Screening
时间窗: Up to 6 months
Acceptability will be measured as the percentage of participants who feel the FIT is an acceptable method of screening. Criterion for success: 90% of participants who complete the FIT find it to be an acceptable method of screening.
次要结局
未报告次要终点
研究者
Erin Kobetz-Kerman, PhD, MPH
Professor
University of Miami