Trials / Completed
CompletedNCT02418494
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)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 85 (actual)
- Sponsor
- AIDS Malignancy Consortium · Network
- Sex
- All
- Age
- 35 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Concept Elicitation | 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 | Comprehension Assessment | Comprehension assessment of draft quality of life assessment |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2016-05-01
- Completion
- 2016-05-01
- First posted
- 2015-04-16
- Last updated
- 2016-06-09
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02418494. Inclusion in this directory is not an endorsement.