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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Baylor College of Medicine
Information provided by (Responsible Party):
Alan G Nyitray, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT02384005
First received: March 3, 2015
Last updated: May 10, 2016
Last verified: May 2016
  Purpose

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.


Condition Intervention
Anus Neoplasms Other: Self-anal exam arm

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: The Feasibility of Self or Partner-assisted Digital Anal Exam Screening

Resource links provided by NLM:


Further study details as provided by Alan G Nyitray, The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Kappa agreement will be calculated between lay person and nurse practitioner on the anal exam results. [ Time Frame: This cross-sectional design measures agreement on Day 1. ]

Secondary Outcome Measures:
  • Odds ratios will be calculated for the association between partnership status and concordance between participant and clinician. [ Time Frame: This cross-sectional design collects data for the odds ratios on Day 1 ]
  • Odds ratios will be calculated for the association between age and concordance between participant and clinician. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: This cross-sectional design collects these data on Day 1 ]
  • Number of persons with adverse events after conducting a self-DAE. [ Time Frame: This cross-sectional design collects these data on Day 1 ]
  • Number of persons who state they have the ability to conduct a self-DAE. [ Time Frame: This cross-sectional design collects these data 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. [ Time Frame: This cross-sectional design collects these data on Day 1 ]

Enrollment: 201
Study Start Date: February 2015
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Self-anal exam arm
Study only has one arm.
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   27 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02384005

Locations
United States, Texas
University of Texas School of Public Health
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Cancer Institute (NCI)
Baylor College of Medicine
Investigators
Principal Investigator: Alan G. Nyitray, PhD University of Texas School of Public Health at Houston
  More Information

Responsible Party: Alan G Nyitray, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02384005     History of Changes
Other Study ID Numbers: HSC-SPH-13-0671
1R21CA181901-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: March 3, 2015
Last Updated: May 10, 2016

Additional relevant MeSH terms:
Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on June 26, 2017