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

AIDS Malignancy Consortium

Status: Completed

Conditions: HIV Infection; High Grade Anal Canal Squamous Intraepithelial Neoplasia

Treatments: Other: Concept Elicitation; Other: Comprehension Assessment

Study type: Observational

Funder types: Other; NETWORK; Industry; NIH

Identifiers

NCT02418494

NCI-2015-00160 (Registry Identifier)

U01CA121947 (U.S. NIH Grant/Contract)

AMC Protocol #A02 (Other Identifier)

AMC-A02 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

85 participants in 1 patient group

Observational (ANCHOR HRQoL interview, cognitive interview)

Description:

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.

Treatment:

Other: Comprehension Assessment

Other: Concept Elicitation