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)
4 other identifiers
observational
85
1 country
6
Brief Summary
This research trial studies health-related symptom questionnaires in measuring quality of life in human immunodeficiency virus (HIV)-infected participants treated with or monitored for anal lesions. Collecting information and symptoms from patients diagnosed with anal lesions may help reduce the risk of anal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2015
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 13, 2015
CompletedFirst Posted
Study publicly available on registry
April 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJune 9, 2016
February 1, 2016
1.1 years
April 13, 2015
June 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Up to 4 months
Study Arms (1)
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.
Interventions
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 of draft quality of life assessment
Eligibility Criteria
Participants diagnosed with HSIL within the prior 6 months enrolled at Weill Cornell Medical College/New York Presbyterian Hospital, Montefiore Medical Center, and Laser Surgery Care Center
You may qualify if:
- HIV-1 infection
- Biopsy-proven anal HSIL within the prior six months
- Life expectancy of greater than 5 years
You may not qualify if:
- History of anal cancer
- Inability to understand a written consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AIDS Malignancy Consortiumlead
- National Cancer Institute (NCI)collaborator
- Memorial Sloan Kettering Cancer Centercollaborator
- Northwestern Universitycollaborator
- The Emmes Company, LLCcollaborator
- University of Arkansascollaborator
Study Sites (6)
University of California at San Francisco - Comprehensive Cancer Center
San Francisco, California, 94143-0875, United States
Anal Dysplasia Clinic
Chicago, Illinois, 60614, United States
Cornell Clinical Trials Unit
New York, New York, 10011, United States
Laser Surgery Care
New York, New York, 10011, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jack Burkhalter
AIDS Associated Malignancies Clinical Trials Consortium
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2015
First Posted
April 16, 2015
Study Start
April 1, 2015
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
June 9, 2016
Record last verified: 2016-02