Clinical trial NCT02418494: Health-Related Symptom Questionnaires in Measuring Quality of Life in HIV-Infected Participants Treated or Monitored for Anal Lesions
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Grade Anal Canal Squamous Intraepithelial Neoplasia
HIV Infection
Lead sponsor: AIDS Malignancy Consortium
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: Memorial Sloan Kettering Cancer Center
name: Northwestern University
name: The Emmes Company, LLC
name: University of Arkansas
First posted: 2015-04-16
Enrollment: 85
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California at San Francisco - Comprehensive Cancer Center
state: California
city: Chicago
country: United States
facility: Anal Dysplasia Clinic
state: Illinois
city: Bronx
country: United States
facility: Montefiore Medical Center-Einstein Campus
state: New York
city: New York
country: United States
facility: Cornell Clinical Trials Unit
state: New York
city: New York
country: United States
facility: Laser Surgery Care
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: AIDS Associated Malignancies Clinical Trials Consortium
name: Jack Burkhalter
role: PRINCIPAL_INVESTIGATOR
References: