CompletedNot Applicable

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

United States20 participantsStarted 2018-11-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: * History of anal cancer. * Inability to understand a written consent form.

What they're measuring

Development of Spanish-language Version of the Anal Cancer/High-grade Squamous Intraepithelial Lesions (HSIL) Outcomes Research (ANCHOR) Health-related Quality of Life (HRQoL) Index-Round 1 and Round 2

Timeframe: 45-60 minutes during the telephone call in each round.

Trial details

NCT IDNCT04276935

SponsorAIDS Malignancy Consortium

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2020-03-01

Results submitted2022-06-30

View on ClinicalTrials.gov More High Grade Anal Canal Squamous Intraepithelial Neoplasia trials