Assessing Drivers and Barriers to Follow-Up Screening for Anal Cancer in Men Who Have Sex With Men

June 21, 2011 updated by: Laser Surgery Care

This study is designed to identify barriers that prevent men who have sex with men from receiving doctor-recommended annual follow-up screenings for anal cancer. Men who are at the highest risk for developing anal cancer will be asked to complete a brief questionnaire (either via telephone or in writing). The questionnaire is designed to identify potential barriers to care-seeking behavior including, relationship status, financial constraints, highest level of education and knowledge about anal cancer and its precursors. The men who agree to participate in the study will then be organized into groups based on their history of coming in for follow-up screening visits after learning that they are at higher risk for developing anal cancer. These groups include 1) men that have come in for regular screening visits (at least once per year), 2) men who came in once and were then lost to follow-up, 3) men who came in for more than one screening visit and were then lost to follow-up, and 4) men who were previously lost to follow-up and then began coming in for screening again. By comparing the men's responses across the different groups, we hope to uncover key barriers and drivers to follow-up screenings for anal cancer.

The goal of this study is to evaluate the differences in questionnaire responses across cohorts that may impact care-seeking behavior.

We hypothesize that:

  • Patients who regularly comply with annual follow-up screening visits score higher on questions assessing knowledge of HPV and anal cancer.
  • Men in stable relationships are more likely to comply with annual screening visit recommendations.
  • Men who are educated by their primary care physicians about the importance of anal cancer screenings have higher screening rates.

Study Overview

Status

Completed

Conditions

Detailed Description

200 subjects will be selected out of a pool of MSM patients in Dr. Stephen Goldstone's private medical practice, Laser Surgery Care, who have in the past and/or are currently being screened for anal dysplasia.

Subjects who come into the office for a follow-up appointment for anal condyloma and/or anal dysplasia treatment will be asked to participate in the study. If written consent is provided, subjects will be asked to complete a written questionnaire.

Subjects will also be selected out of a pool of patients who have been lost to follow-up, defined as having failed to come in for a follow-up visit > 12 months after their last appointment for treatment or screening for anal condyloma and/or anal dysplasia. These subjects will be contacted via telephone and asked to participate in a brief telephone interview (approximately 14 minutes in duration). The interview is identical to the written questionnaire. At the conclusion of the interview, subjects will be given the opportunity to schedule a follow-up appointment.

Medical records for all subjects who agree to participate in the study will be used to confirm screening visit history as well as history and severity of dysplasia. In addition, HIV status will also be confirmed by review of the medical chart. Data will be entered into an anonymous medical record summary sheet. Information will then be entered into an electronic database identified only by subject number.

Subjects will be divided into cohorts based on follow-up care seeking behavior: 1) those who come in for regular screening defined as at least once per year, 2) those who came in once and were lost to follow-up, 3) those who came in for more than one screening visit and were then lost to follow-up, and 4) those who were previously lost to follow-up and then began coming in for screening again. Questionnaire responses will be compared across cohorts to determine which variables differ significantly. t-Tests, one way, and multivariate analysis of variance, and correlation analysis will be used as indicated by variable type.

Patients will not receive any compensation for their participation in the study.

Study Type

Observational

Enrollment (Actual)

195

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10011
        • Laser Surgery Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients seen in the clinical practice that either had screening for dysplasia, stopped having screening or returned for screening after a period of absence.

Description

Inclusion Criteria:

  • MSM patients in Dr. Stephen Goldstone's private surgical practice who previously tested positive for one of the known HPV subtypes (HPV types 6, 11, 16, 18, 31, 33 and 35) and developed condyloma and/or dysplasia in the anogenital region.

Exclusion Criteria:

  • Failure to provide consent to participate in the telephone or written questionnaire.
  • Development of anal cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laser Surgery Care

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Stephen E. Goldstone, M.D., Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

July 12, 2007

First Submitted That Met QC Criteria

July 13, 2007

First Posted (Estimate)

July 16, 2007

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-0337-2
  • 32873 (Other Grant/Funding Number: Merck and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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