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

Completed

• Conditions: HIV Infection; High Grade Anal Canal Squamous Intraepithelial Neoplasia
• Interventions: Other: Concept Elicitation; Other: Comprehension Assessment

• Registration Number: NCT02418494
• Lead Sponsor: AIDS Malignancy Consortium

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-13
• Study First Submitted QC: 2015-04-13
• Study First Posted: 2015-04-16
• Status Verified: 2016-02
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-06-08
• Last Update Posted: 2016-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (ANCHOR HRQoL interview, cognitive interview)	Comprehension Assessment	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 undergo a cognitive interview for up to 3 sessions.
Observational (ANCHOR HRQoL interview, cognitive interview)	Concept Elicitation	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 undergo a cognitive interview for up to 3 sessions.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Anal Dysplasia Clinic; 🇺🇸 Chicago, Illinois, United States

University of California at San Francisco - Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

Montefiore Medical Center-Einstein Campus; 🇺🇸 Bronx, New York, 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