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

Completed

Conditions: High Grade Anal Canal Squamous Intraepithelial Neoplasia
Human Immunodeficiency Virus

Interventions: Other: Interview
Other: Quality-of-Life Assessment
Other: Questionnaire Administration

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Health Services Research (cognitive interviews)	Quality-of-Life Assessment	Participants take part in cognitive interviews in Spanish over 45-60 minutes.
Health Services Research (cognitive interviews)	Questionnaire Administration	Participants take part in cognitive interviews in Spanish over 45-60 minutes.
Health Services Research (cognitive interviews)	Interview	Participants take part in cognitive interviews in Spanish over 45-60 minutes.

Primary Outcome Measures

Name	Time	Method
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	45-60 minutes during the telephone call in each round.	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.

Secondary Outcome Measures

Name	Time	Method

Locations (4): University of California - San Francisco
🇺🇸
San Francisco, California, United States
Jackson Memorial Hospital
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Miami, Florida, United States
Anal Dysplasia Clinic MidWest
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Chicago, Illinois, United States
Virginia Mason Medical Center
🇺🇸
Seattle, Washington, United States