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NCT02418494 Clinical Trial

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

HIV Infection Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02418494
Other study ID # AMC-A02
Secondary ID NCI-2015-00160AM
Status Completed
Phase N/A
First received April 13, 2015
Last updated June 8, 2016
Start date April 2015
Est. completion date May 2016

Study information
Verified date February 2016
Source AIDS Malignancy Consortium
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 85
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 35 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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
• Comprehension Assessment
Comprehension assessment of draft quality of life assessment

Locations
Country Name City State
United States Montefiore Medical Center-Einstein Campus Bronx New York
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 Memorial Sloan-Kettering Cancer Center New York New York
United States University of California at San Francisco - Comprehensive Cancer Center San Francisco California

Sponsors (6)
Lead Sponsor Collaborator
AIDS Malignancy Consortium Memorial Sloan Kettering Cancer Center, National Cancer Institute (NCI), Northwestern University, The EMMES Corporation, University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Up to 4 months No
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