Health-Related Symptom Questionnaires in Measuring Quality of Life in HIV-Infected Participants Treated or Monitored for Anal Lesions
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 35 - Any |
| Updated: | 6/10/2016 |
| Start Date: | April 2015 |
| End Date: | May 2016 |
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.
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.
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.
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.
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
We found this trial at
6
sites
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Bronx, New York 10461
Principal Investigator: Mark H. Einstein
Phone: 718-904-2730
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New York, New York 10021
Principal Investigator: Timothy J. Wilkin
Phone: 212-746-1848
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New York, New York 10011
Principal Investigator: Stephen E. Goldstone
Phone: 212-242-6500
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Jack E. Burkhalter
Phone: 646-888-0040
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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San Francisco, California 94143
Principal Investigator: Nicolas Sheon
Phone: 415-476-6371
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