Development of a Health-Related Symptom Index for Persons Diagnosed With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions (HSIL)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- High Grade Anal Canal Squamous Intraepithelial Neoplasia
- Sponsor
- AIDS Malignancy Consortium
- Enrollment
- 85
- Locations
- 6
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
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
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