N/A
N=20
Development of a Health-Related Symptom Index for Participants With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions
High Grade Anal Canal Squamous Intraepithelial Neoplasia · Human Immunodeficiency Virus
Bottom Line
View on ClinicalTrials.gov: NCT04276935 ↗Enrolled (actual)
20
Serious AEs
—
Results posted
Nov 2023
Primary outcome: Primary: 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 — 4; 3; 3; 3 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Interview (Other); Quality-of-Life Assessment (Other); Questionnaire Administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AIDS Malignancy Consortium
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
4; 3; 3; 3; 3; 3 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04276935). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.