Anal CancerNCT00501306
Assessing Drivers and Barriers to Follow-Up Screening for Anal Cancer in Men Who Have Sex With Men
An observational study of Anal Cancer, run by Laser Surgery Care at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Anal Cancer
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to May 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Failure to provide consent to participate in the telephone or written questionnaire.
- Development of anal cancer.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Anal Cancer
- Keywords
- Condyloma Accuminata, Low Grade Squamous Intraepithelial Lesion, High Grade Squamous Intraepithelial Lesion, Anal Cancer Screening
- Medical subject headings
- Anus Neoplasms, Squamous Intraepithelial Lesions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laser Surgery Care
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Stephen E. Goldstone, M.D., Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501306
- Sponsor's protocol ID
- 07-0337-2
- Other IDs
- 32873
- Status last verified
- Jun 2011
- First submitted
- 12 Jul 2007
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20852198
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Drivers and Barriers to Follow-Up Screening for Anal Cancer in Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT00501306
- Acronym / sponsor ID
- 07-0337-2
- Conditions
- Anal Cancer
- Keywords
- Condyloma Accuminata, Low Grade Squamous Intraepithelial Lesion, High Grade Squamous Intraepithelial Lesion, Anal Cancer Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Laser Surgery CareUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jun 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 16 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Failure to provide consent to participate in the telephone or written questionnaire.
- Development of anal cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
- Results publication: PubMed 20852198Truesdale 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen E. Goldstone, M.D. principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Cancer, run by Laser Surgery Care at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00501306, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.