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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-06

Study Completion Date

2020-03-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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High Grade Anal Canal Squamous Intraepithelial Neoplasia Human Immunodeficiency Virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Health Services Research (cognitive interviews)

Participants take part in cognitive interviews in Spanish over 45-60 minutes.

Interview

Intervention Type OTHER

Participate in cognitive interview

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Interview

Participate in cognitive interview

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Quality of Life Assessment

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Atkinson

Role: PRINCIPAL_INVESTIGATOR

AIDS Malignancy Consortium

Locations

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University of California - San Francisco

San Francisco, California, United States

Site Status

Jackson Memorial Hospital

Miami, Florida, United States

Site Status

Anal Dysplasia Clinic MidWest

Chicago, Illinois, United States

Site Status

Virginia Mason Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document