Health-Related Symptom Questionnaires in Measuring Quality of Life in HIV-Infected Participants Treated or Monitored for Anal Lesions

AIDS Malignancy Consortium85 enrolled

Overview

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.

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

OBSERVATIONAL

Enrollment

Conditions

High Grade Anal Canal Squamous Intraepithelial Neoplasia HIV Infection

Interventions

Concept ElicitationOTHER

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 AssessmentOTHER

Comprehension assessment of draft quality of life assessment

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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

Locations (6)

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

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.