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 |
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.
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
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, New York 10021
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