Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Grade Anal Canal Squamous Intraepithelial Neoplasia | High Grade Anal Canal Intraepithelial Neoplasia | ALIAS | 0.90 |
| Human Immunodeficiency Virus | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interview | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Health Services Research (cognitive interviews)
- description
- Participants take part in cognitive interviews in Spanish over 45-60 minutes.
- interventionNames
- Other: Interview
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- 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.
- description
- Participants completed A-HRSI, as aurally administered over telephone to indicate whether there were any items or aspects of the instructions that were difficult to understand, and then complete a process of retrospective probing. Summary reports from the Round 1 interview were coded to highlight any instances where a participant indicated that they experienced difficulty with an item or concept within an item. For any item that was reported by at least three participants as difficult for any reason, that item or concept was reviewed to determine whether the difficulty was due to (1) the concept being measured or (2) a translation issue (i.e., register, jargon, or regionalism). These items were revised during a research team panel discussion and used in Round 2 interviews with additional eligible participants. A similar process was used for Round 2.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available