Health-Related Symptom Questionnaires in Measuring Quality of Life in HIV-Infected Participants Treated or Monitored for Anal Lesions

June 8, 2016 updated by: AIDS Malignancy Consortium

Development of a Health-Related Symptom Index for Persons Diagnosed With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions (HSIL)

This research trial studies health-related symptom questionnaires in measuring quality of life in human immunodeficiency virus (HIV)-infected participants treated with or monitored for anal lesions. Collecting information and symptoms from patients diagnosed with anal lesions may help reduce the risk of anal cancer.

Study Overview

Detailed Description

PRIMARY OBJECTIVES:

I. To develop an Anal Cancer/HSIL Outcomes Research Study (ANCHOR) high-grade squamous intraepithelial lesion (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 complete the ANCHOR HSIL HRQoL interview over 45-60 minutes, comparing the list of symptoms, concerns, or HRQOL impacts related to HSIL diagnosis and treatment. Some patients also complete a cognitive interview for up to 3 sessions.

Study Type

Observational

Enrollment (Actual)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Francisco, California, United States, 94143-0875
        • University of California at San Francisco - Comprehensive Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Anal Dysplasia Clinic
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center-Einstein Campus
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10011
        • Laser Surgery Care
      • New York, New York, United States, 10011
        • Cornell Clinical Trials Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants diagnosed with HSIL within the prior 6 months enrolled at Weill Cornell Medical College/New York Presbyterian Hospital, Montefiore Medical Center, and Laser Surgery Care Center

Description

Inclusion Criteria:

  • HIV-1 infection
  • Biopsy-proven anal HSIL within the prior six months
  • Life expectancy of greater than 5 years

Exclusion Criteria:

  • History of anal cancer
  • Inability to understand a written consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (ANCHOR HRQoL interview, cognitive interview)
Participants complete the ANCHOR HSIL HRQoL interview over 45-60 minutes, comparing the list of symptoms, concerns, or HRQOL impacts related to HSIL diagnosis and treatment. Some patients also undergo a cognitive interview for up to 3 sessions.
Complete cognitive interview to elicit relevant HSIL symptoms, compare to study index of symptoms, and rank symptoms in relation to effect on health-related quality of life
Other Names:
  • Cognitive Interview
Comprehension assessment of draft quality of life assessment
Other Names:
  • Cognitive Interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development of an 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.
Time Frame: Up to 4 months
Up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

April 13, 2015

First Posted (Estimate)

April 16, 2015

Study Record Updates

Last Update Posted (Estimate)

June 9, 2016

Last Update Submitted That Met QC Criteria

June 8, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • AMC-A02 (Other Identifier: CTEP)
  • U01CA121947 (U.S. NIH Grant/Contract)
  • NCI-2015-00160 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • AMC Protocol #A02 (Other Identifier: AIDS Malignancy Clinical Trials Consortium)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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