The Feasibility of Self or Partner-assisted Digital Anal Exam Screening

Anus Neoplasms Clinical Trial

Official title:

The Feasibility of Self or Partner-assisted Digital Anal Exam Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02384005
• Other study ID #: HSC-SPH-13-0671
• Secondary ID: 1R21CA181901-01A
• Status: Recruiting
• Phase: N/A
• First received: March 3, 2015
• Last updated: December 1, 2015
• Start date: February 2015
• Est. completion date: June 2016

Study information

• Verified date: December 2015
• Source: The University of Texas Health Science Center, Houston
• Contact: Alan G. Nyitray, PhD
• Phone: 713-500-9354
• Email: alan.g.nyitray[@]uth.tmc.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

1. 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 27 Years to 80 Years

Eligibility

Inclusion Criteria:

• Men who are aged 27-80 years

• Acknowledge sex with men in their lifetime

• Reside in Harris County, Texas

• Understand and speak English.

Exclusion Criteria:

• Current doctor's diagnosis of anal condyloma, hemorrhoids, fissures, or anal cancer

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Anus Neoplasms

Intervention

Other:
• Self-anal exam arm
After a short pre-test the clinician will use a model to show a normal and diseased anal canal and then use pictures to show a self-DAE. The clinician will describe how to do a self-DAE for single men and partners. Next, the clinician will ask the participant to lower his pants for collection of anal human papillomavirus (HPV) DNA and cytology. The clinician will conduct a DAE and then participants will do self-DAE done in private. Then the research assistant will demonstrate the computer-assisted self-interview. When participants return to the clinician to receive the DAE results, the clinician will conduct a safety-related interview. The clinician will treat external anal disease, triage internal anal disease, and ask to be notified if a participant has any anus-related concerns in the following week. A complete appointment will require 70 minutes for singles and 105 minutes for couples. The PI will later conduct 3 focus groups.

Locations

Country	Name	City	State
United States	University of Texas School of Public Health	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Baylor College of Medicine, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kappa agreement will be calculated between lay person and nurse practitioner on the anal exam results.		This cross-sectional design measures agreement on Day 1.	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Number of persons who state that a self-DAE is an acceptable procedure.		This cross-sectional design collects these data on Day 1	No
Secondary	Number of persons with adverse events after conducting a self-DAE.		This cross-sectional design collects these data on Day 1	Yes
Secondary	Number of persons who state they have the ability to conduct a self-DAE.		This cross-sectional design collects these data on Day 1	No
Secondary	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	No