The Feasibility of Self or Partner-assisted Digital Anal Exam Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Kappa agreement will be calculated between lay person and nurse practitioner on the anal exam results.
研究概览
简要总结
There is no standard screening protocol for anal cancer even as disease incidence increases. This single-visit study will clarify if single persons can do a self-digital anal exam, or perhaps the exam requires a partner, or if, in fact, the exam requires a clinician for reasons of safety, accuracy, or acceptability.
The investigators hypothesize that men having sex with men's digital anal exam (DAE) findings will have moderate or substantial agreement with a nurse practitioner DAE for detecting an anal abnormality (defined as condylomas, hemorrhoids, fissures, and malignant tumors). As a secondary hypothesis the investigator believe a partner-assisted DAE conducted within a couple will have better agreement with the nurse practitioner DAE than will a self-DAE conducted by a single person.
详细描述
There is no standard screening protocol for anal cancer even as disease incidence and mortality increases; however, a digital anorectal exam (also called a digital rectal exam) will play a role in any recommended protocol. Critically, fewer digital anorectal exams are being performed by physicians even though it is a simple and quick procedure. If men who have sex with men (MSM) can learn to examine the anal canal, then detection and treatment of early cancers among this population may increase. This single-visit Phase II feasibility study will investigate increasing digital anal exam (DAE) use to enhance screening for anal cancer among MSM aged 27-80 years. The investigators hypothesize that MSM's DAE findings will have moderate or substantial agreement with a nurse practitioner DAE for detecting an anal abnormality (defined as condylomas, hemorrhoids, fissures, and malignant tumors). As a secondary hypothesis the investigators believe a partner-assisted DAE conducted within a couple will have better agreement with the nurse practitioner DAE than will a self-DAE conducted by a single person. It is not proposed that lay persons recognize specific conditions but, rather, that any abnormality should trigger a doctor visit. The specific aims are:
- Estimate the agreement between the digital anal exams of 200 MSM and the gold standard of a highly experienced nurse practitioner during a single clinical visit.
This aim will answer the question: under optimal circumstances, will MSM report accurate findings after performing their own DAE? 2. Determine factors independently associated with concordance of MSM and nurse practitioner DAEs including age, single men vs. men in couples, race, ethnicity and waist circumference.
This aim will provide insight into which MSM are more likely to perform accurate DAEs. 3. Assess DAE acceptability, self-efficacy, safety, and intentions-to-seek subsequent care.
This aim will answer the question: will lay-performed DAEs have sufficient acceptability and safety and trigger appropriate follow-up care?
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
- 27 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men who are aged 27-80 years
- •Acknowledge sex with men in their lifetime
- •Reside in Harris County, Texas
- •Understand and speak English.
排除标准
- •Current doctor's diagnosis of anal condyloma, hemorrhoids, fissures, or anal cancer
研究组 & 干预措施
Self-anal exam arm
Study only has one arm.
干预措施: Self-anal exam arm (Other)
结局指标
主要结局
Kappa agreement will be calculated between lay person and nurse practitioner on the anal exam results.
时间窗: This cross-sectional design measures agreement on Day 1.
次要结局
- Odds ratios will be calculated for the association between partnership status and concordance between participant and clinician.(This cross-sectional design collects data for the odds ratios on Day 1)
- Odds ratios will be calculated for the association between ethnicity and concordance between participant and clinician.(This cross-sectional design collects data for the odds ratios on Day 1)
- Number of persons who state they intend to seek subsequent care in the event of an abnormal result to a self-DAE.(This cross-sectional design collects these data on Day 1)
- Odds ratios will be calculated for the association between age and concordance between participant and clinician.(This cross-sectional design collects data for the odds ratios on Day 1)
- Odds ratios will be calculated for the association between waist circumference and concordance between participant and clinician.(This cross-sectional design collects data for the odds ratios on Day 1)
- Odds ratios will be calculated for the association between race and concordance between participant and clinician.(This cross-sectional design collects data for the odds ratios on Day 1)
- Number of persons who state that a self-DAE is an acceptable procedure.(This cross-sectional design collects these data on Day 1)
- Number of persons with adverse events after conducting a self-DAE.(This cross-sectional design collects these data on Day 1)
- Number of persons who state they have the ability to conduct a self-DAE.(This cross-sectional design collects these data on Day 1)
研究者
Alan G Nyitray
Assistant Professor
The University of Texas Health Science Center, Houston