Health-Related Symptom Questionnaires in Measuring Quality of Life in HIV-Infected Participants Treated or Monitored for Anal Lesions
NCT ID: NCT02418494
Last Updated: 2016-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
85 participants
OBSERVATIONAL
2015-04-30
2016-05-31
Brief Summary
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Detailed Description
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I. To develop an Anal Cancer/HSIL Outcomes Research Study (ANCHOR) high-grade squamous intraepithelial lesion (HSIL) health-related quality of life (HRQoL) Index (HQI) using state-of-the-art measure development methodology that captures the most important HRQoL symptoms and concerns of those persons diagnosed with anal HSIL and either treated or untreated for anal HSIL.
OUTLINE:
Participants complete the ANCHOR HSIL HRQoL interview over 45-60 minutes, comparing the list of symptoms, concerns, or HRQOL impacts related to HSIL diagnosis and treatment. Some patients also complete a cognitive interview for up to 3 sessions.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Observational (ANCHOR HRQoL interview, cognitive interview)
Participants complete the ANCHOR HSIL HRQoL interview over 45-60 minutes, comparing the list of symptoms, concerns, or HRQOL impacts related to HSIL diagnosis and treatment. Some patients also undergo a cognitive interview for up to 3 sessions.
Concept Elicitation
Complete cognitive interview to elicit relevant HSIL symptoms, compare to study index of symptoms, and rank symptoms in relation to effect on health-related quality of life
Comprehension Assessment
Comprehension assessment of draft quality of life assessment
Interventions
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Concept Elicitation
Complete cognitive interview to elicit relevant HSIL symptoms, compare to study index of symptoms, and rank symptoms in relation to effect on health-related quality of life
Comprehension Assessment
Comprehension assessment of draft quality of life assessment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Biopsy-proven anal HSIL within the prior six months
* Life expectancy of greater than 5 years
Exclusion Criteria
* Inability to understand a written consent form
35 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
Northwestern University
OTHER
The Emmes Company, LLC
INDUSTRY
University of Arkansas
OTHER
AIDS Malignancy Consortium
NETWORK
Responsible Party
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Principal Investigators
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Jack Burkhalter
Role: PRINCIPAL_INVESTIGATOR
AIDS Associated Malignancies Clinical Trials Consortium
Locations
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University of California at San Francisco - Comprehensive Cancer Center
San Francisco, California, United States
Anal Dysplasia Clinic
Chicago, Illinois, United States
Cornell Clinical Trials Unit
New York, New York, United States
Laser Surgery Care
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Countries
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Other Identifiers
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NCI-2015-00160
Identifier Type: REGISTRY
Identifier Source: secondary_id
AMC Protocol #A02
Identifier Type: OTHER
Identifier Source: secondary_id
AMC-A02
Identifier Type: OTHER
Identifier Source: secondary_id
AMC-A02
Identifier Type: OTHER
Identifier Source: secondary_id
AMC-A02
Identifier Type: -
Identifier Source: org_study_id
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