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

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.

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Key information

Conditions

High Grade Anal Canal Squamous Intraepithelial Neoplasia Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infection HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Concept Elicitation

Other

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 names: Cognitive Interview

Comprehension Assessment

Other

Comprehension assessment of draft quality of life assessment

Other names: Cognitive Interview

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

Sponsors and collaborators

Lead sponsor

AIDS Malignancy Consortium

Network

Collaborators

Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Northwestern University
The Emmes Company, LLC
University of Arkansas

Registry information

Official study 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)

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Apr 16, 2015
Registry last updated: Jun 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed