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

Status:	Completed
Conditions:	HIV / AIDS
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	35 - Any
Updated:	6/10/2016
Start Date:	April 2015
End Date:	May 2016

Development of a Health-Related Symptom Index for Persons Diagnosed With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions (HSIL)

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.

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

We found this trial at

sites

The Cornell Clinical Trials Unit

New York, New York 10021

Principal Investigator: Timothy J. Wilkin

Phone: 212-746-1848

from

New York, NY