Development of a Health-Related Symptom Index for Participants With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions

AIDS Malignancy Consortium

Status

Completed

Conditions

Human Immunodeficiency Virus

High Grade Anal Canal Squamous Intraepithelial Neoplasia

Treatments

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Interview

Study type

Observational

Funder types

Other

NETWORK

Industry

NIH

Identifiers

NCT04276935

U54CA137788 (U.S. NIH Grant/Contract)

NCI-2018-01740 (Registry Identifier)

AMC-A04 (Other Identifier)

UM1CA121947 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This trial develops a health-related symptom index for participants with and either treated or monitored for anal high-grade squamous intraepithelial lesions. The health-related quality of life index may help to capture the symptoms and related experiences of living with or being treated for high-grade squamous intraepithelial lesions.

Full description

PRIMARY OBJECTIVES:

I. To develop a Spanish-language version of the anal cancer/high-grade squamous intraepithelial lesions outcomes research (ANCHOR) high-grade squamous intraepithelial lesions (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 take part in cognitive interviews in Spanish over 45-60 minutes.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Human immunodeficiency virus (HIV)-1 infection.
Biopsy-proven anal HSIL within the prior nine months.
Participant must have received anal HSIL treatment in the last nine months. If the participant's treatment plan is observation? the participant must have been diagnosed with anal HSIL in the last nine months.
Life expectancy of greater than 5 years.
Fluent in Spanish with limited English proficiency, per self-report.

Exclusion criteria