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.

Public Health Relevance

There is no standard screening protocol for anal cancer even as disease incidence increases. This study will clarify if single persons can do a self-digital ana exam, or perhaps the exam requires a partner, or if, in fact, the exam requires a clinician for reasons of safety, accuracy, or acceptability.

Agency
National Institute of Health (NIH)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21CA181901-01A1
Application #
8757029
Study Section
Special Emphasis Panel (ZCA1)
Program Officer
Marquez, Guillermo
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2014
Total Cost
Indirect Cost
Name
University of Texas Health Science Center Houston
Department
Internal Medicine/Medicine
Type
Schools of Public Health
DUNS #
City
Houston
State
TX
Country
United States
Zip Code
77225