Clinical trial NCT04276935: Development of a Health-Related Symptom Index for Participants With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Grade Anal Canal Squamous Intraepithelial Neoplasia
Human Immunodeficiency Virus
Lead sponsor: AIDS Malignancy Consortium
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: Memorial Sloan Kettering Cancer Center
name: The Emmes Company, LLC
First posted: 2020-02-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected adult men and women with biopsy-proven anal HSIL that was treated in the last 9 months, and who are fluent in Spanish with limited English proficiency.

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.

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.

Primary outcomes:
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.
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Chicago
country: United States
facility: Anal Dysplasia Clinic MidWest
state: Illinois
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: AIDS Malignancy Consortium
name: Thomas Atkinson
role: PRINCIPAL_INVESTIGATOR
References: