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

NCT00501306 | Completed

• 2 other identifiers: 07-0337-232873
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anal Cancer

Keywords

Condyloma Accuminata; Low Grade Squamous Intraepithelial Lesion; High Grade Squamous Intraepithelial Lesion; Anal Cancer Screening

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Laser Surgery Care: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Laser Surgery Care

New York, New York, 10011, United States

Location

Related Publications (1)

• Truesdale MD, Goldstone SE. The fear factor: drivers and barriers to follow-up screening for human papillomavirus-related anal cancer in men who have sex with men. Int J STD AIDS. 2010 Jul;21(7):482-8. doi: 10.1258/ijsa.2010.010070.

  PMID: 20852198 RESULT

MeSH Terms

Conditions

Anus Neoplasms; Squamous Intraepithelial Lesions

Condition Hierarchy (Ancestors)

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; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen E. Goldstone, M.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 12, 2007
• First Posted: July 16, 2007
• Study Start: June 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: June 23, 2011

Record last verified: 2011-06

Locations

US (1)