NCT04276935

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

Development of a Health-Related Symptom Index for Spanish-Speaking Persons Diagnosed With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions (HSIL)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: AIDS Malignancy Consortium · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• High Grade Anal Canal Squamous Intraepithelial Neoplasia
• Human Immunodeficiency Virus

Interventions

Type	Name	Description
OTHER	Interview	Participate in cognitive interview
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2018-11-06
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2020-02-19
• Last updated: 2025-03-07
• Results posted: 2023-11-18

Locations

4 sites across 1 country: United States