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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02836522
Recruitment Status : Active, not recruiting
First Posted : July 19, 2016
Last Update Posted : June 16, 2020
Sponsor:
Collaborators:
The City College of New York
Northwestern University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to finalize development of a questionnaire that measures health-related symptoms and concerns for persons diagnosed with, and either treated or monitored for, anal pre-cancer lesions.

Condition or disease Intervention/treatment
Anal High-Grade Squamous Intraepithelial Lesions Behavioral: Assessment of Health-Related Quality

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Study Type : Observational
Actual Enrollment : 406 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation 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 25, 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: Assessment of Health-Related Quality
    Demographic Questionnaire, ANCHOR HRSI, FACT-G, MDASI, Patient ECOG PS, PGIC


Primary Outcome Measures :
  1. degree of test-retest reliability in the ANCHOR HRSI [ Time Frame: 7-10 days ]
    measure from the initial assessment point to the 7-10 day follow-up.



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
participating ANCHOR sites
Criteria

Inclusion Criteria:

  • Consented to the ANCHOR trial as per self-report and by providing a valid referral code on the information sheet provided by the referring site. Both men and women from the ANCHOR trial will be recruited to this study.
  • English fluent as we are only validating this measure in English at this time
  • At least one month post-treatment for anal HSIL as per self-report, or if the person is in the ANCHOR trial observation arm, then at least one month post- randomization.
  • Within two weeks post initial-treatment for anal HSIL on ANCHOR study or within two weeks post-randomization to ANCHOR study as per self-report.

NOTES:

  • ANCHOR participants who are randomized to the treatment arm must have completed initial treatment and are within two weeks of initial treatment completion.
  • ANCHOR participants who were treated initially with topical treatment are only eligible within two weeks after the last topical treatment application.
  • ANCHOR participants who were treated initially with both topical and ablation treatments are eligible within two weeks of completing both treatments.
  • ANCHOR participants who are randomized to the active monitoring arm are eligible if they are within two weeks of randomization

Exclusion Criteria:

  • Has a scheduled ANCHOR follow-up appointment in the next two weeks as per self report. The purpose of this exclusion criterion is to minimize the impact on a participant's responses to a post-test evaluation the potential occurrence of an interim diagnosis or treatment event, or anxiety related to an upcoming medical follow-up.

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): NCT02836522


Locations
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United States, Illinois
Northwestern University
Evanston, Illinois, United States, 60208
United States, New York
Memorial Sloan - Kettering Cancer Center
New York, New York, United States, 10021
City College of New York
New York, New York, United States, 10031
New York Presbyterian Hospital-Weill Medical College of Cornell University
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
The City College of New York
Northwestern University
Investigators
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Principal Investigator: Thomas Atkinson, PhD Memorial Sloan Kettering Cancer Center
  Study Documents (Full-Text)

Documents provided by Memorial Sloan Kettering Cancer Center:
Informed Consent Form  [PDF] April 20, 2018

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02836522    
Other Study ID Numbers: 16-282
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
Health-Related Symptom Index
ANCHOR( ANal Cancer HSIL (high grade squamous intraepithelial lesions) Outcomes Research study)
Additional relevant MeSH terms:
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Squamous Intraepithelial Lesions of the Cervix
Uterine Cervical Dysplasia
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases