- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02418494
Health-Related Symptom Questionnaires in Measuring Quality of Life in HIV-Infected Participants Treated or Monitored for Anal Lesions
Development of a Health-Related Symptom Index for Persons Diagnosed With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions (HSIL)
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
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San Francisco, California, United States, 94143-0875
- University of California at San Francisco - Comprehensive Cancer Center
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Illinois
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Chicago, Illinois, United States, 60614
- Anal Dysplasia Clinic
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New York
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Bronx, New York, United States, 10461
- Montefiore Medical Center-Einstein Campus
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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New York, New York, United States, 10011
- Laser Surgery Care
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New York, New York, United States, 10011
- Cornell Clinical Trials Unit
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- HIV-1 infection
- Biopsy-proven anal HSIL within the prior six months
- Life expectancy of greater than 5 years
Exclusion Criteria:
- History of anal cancer
- Inability to understand a written consent form
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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
Other Names:
Comprehension assessment of draft quality of life assessment
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Development of an 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.
Time Frame: Up to 4 months
|
Up to 4 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMC-A02 (Other Identifier: CTEP)
- U01CA121947 (U.S. NIH Grant/Contract)
- NCI-2015-00160 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- AMC Protocol #A02 (Other Identifier: AIDS Malignancy Clinical Trials Consortium)
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