The feasibility of self or partner-assisted digital anal exam screening

自我或伴侣协助数字肛门检查筛查的可行性

• 批准号: 8892125
• 负责人: ALAN GASPAR NYITRAY
• 金额: $ 16.63万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-15 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8892125
• 关键词: Age; Agreement; Anal canal; Anatomy; Anus; Behavioral; Caring; Clinic; Clinical; Colposcopy; Communities; Couples; Data; Detection; Diagnostic; Disease; Early Diagnosis; Early treatment; Educational process of instructing; Effectiveness; Eligibility Determination; Ethnic Origin; Feasibility Studies; Goals; Gold; Health; Hemorrhoids; Human Papillomavirus; Human papilloma virus infection; Incidence; Knowledge; Learning; Literature; Malignant Neoplasms; Malignant neoplasm of anus; Malignant neoplasm of cervix uteri; Methods; Modality; Modeling; Molecular; Morbidity - disease rate; Nurse Practitioners; Pap smear; Participant; Pelvis; Persons; Phase; Physicians; Play; Population; Positioning Attribute; Procedures; Protocols documentation; Race; Recording of previous events; Recruitment Activity; Reporting; Research; Research Infrastructure; Resolution; Role; Safety; Self Efficacy; Testing; Training; United States; Unmarried person; Visit; aged; analog; condyloma; design; digital; efficacy trial; experience; follow-up; high risk; innovation; insight; medical schools; men; men who have sex with men; mortality; online tutorial; phase III trial; prevent; rectal; screening; skills; tumor; waist circumference

DESCRIPTION (provided by applicant): 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 Phase II feasibility study will investigate increasing digital anal exam (DAE) use to enhance screening for anal cancer among MSM aged 27-80 years. We 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 we 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: 1. Estimate the agreement between the digital anal exams of 200 MSM and the gold standard of a highly experienced nurse practitioner. 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? The goal is to advance knowledge of how to increase use of digital anal exams to reduce anal cancer morbidity and mortality. The 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.

描述（由申请人提供）：尽管肛门癌的发病率和死亡率在增加，但没有标准的筛查方案；然而，肛肠指检（也称为直肠指检）将在任何推荐的方案中发挥作用。至关重要的是,更少的

项目成果

A phase II clinical study to assess the feasibility of self and partner anal examinations to detect anal canal abnormalities including anal cancer.

• DOI: 10.1136/sextrans-2017-053283
• 发表时间: 2018-03
• 期刊: Sexually transmitted infections
• 影响因子: 3.6
• 作者: Nyitray AG;Hicks JT;Hwang LY;Baraniuk S;White M;Millas S;Onwuka N;Zhang X;Brown EL;Ross MW;Chiao EY
• 通讯作者: Chiao EY

A qualitative investigation among men who have sex with men on the acceptability of performing a self- or partner anal exam to screen for anal cancer.

• DOI: 10.1007/s10552-017-0935-6
• 发表时间: 2017-10
• 期刊: Cancer causes & control : CCC
• 作者: Butame SA;Lawler S;Hicks JT;Wilkerson JM;Hwang LY;Baraniuk S;Ross MW;Chiao EY;Nyitray AG
• 通讯作者: Nyitray AG