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

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ClinicalTrials.gov Identifier: NCT02418494
Recruitment Status : Completed
First Posted : April 16, 2015
Last Update Posted : June 9, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Northwestern University
The Emmes Company, LLC
University of Arkansas
Information provided by (Responsible Party):
AIDS Malignancy Consortium

Brief Summary:
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.

Condition or disease Intervention/treatment
High Grade Anal Canal Squamous Intraepithelial Neoplasia HIV Infection Other: Concept Elicitation Other: Comprehension Assessment

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.


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Study Type : Observational
Actual Enrollment : 85 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of a Health-Related Symptom Index for Persons Diagnosed With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions (HSIL)
Study Start Date : April 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.
Other: Concept Elicitation
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 Name: Cognitive Interview

Other: Comprehension Assessment
Comprehension assessment of draft quality of life assessment
Other Name: Cognitive Interview




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02418494


Locations
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United States, California
University of California at San Francisco - Comprehensive Cancer Center
San Francisco, California, United States, 94143-0875
United States, Illinois
Anal Dysplasia Clinic
Chicago, Illinois, United States, 60614
United States, New York
Montefiore Medical Center-Einstein Campus
Bronx, New York, United States, 10461
Cornell Clinical Trials Unit
New York, New York, United States, 10011
Laser Surgery Care
New York, New York, United States, 10011
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
AIDS Malignancy Consortium
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Northwestern University
The Emmes Company, LLC
University of Arkansas
Investigators
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Principal Investigator: Jack Burkhalter AIDS Associated Malignancies Clinical Trials Consortium

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Responsible Party: AIDS Malignancy Consortium
ClinicalTrials.gov Identifier: NCT02418494     History of Changes
Other Study ID Numbers: AMC-A02
NCI-2015-00160 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AMC Protocol #A02 ( Other Identifier: AIDS Malignancy Clinical Trials Consortium )
AMC-A02 ( Other Identifier: AIDS Malignancy Clinical Trials Consortium )
AMC-A02 ( Other Identifier: CTEP )
U01CA121947 ( U.S. NIH Grant/Contract )
First Posted: April 16, 2015    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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HIV Infections
Neoplasms
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases