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



Status:Enrolling by invitation
Healthy:No
Age Range:35 - Any
Updated:2/1/2019
Start Date:April 25, 2016
End Date:April 2019

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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.


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.
We found this trial at
4
sites
Evanston, Illinois 60208
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, New York 10031
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New York, NY
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