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Completed

NCT Number: NCT04276935

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

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.

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Key information

Conditions

High Grade Anal Canal Squamous Intraepithelial Neoplasia Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Human Immunodeficiency Virus Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California - San Francisco, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

interview

Other

Participate in cognitive interview

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AIDS Malignancy Consortium

Network

Collaborators

  • Memorial Sloan Kettering Cancer Center
  • National Cancer Institute (NCI)
  • The Emmes Company, LLC

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 19, 2020
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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