Validation of a Health-Related Symptom Index for Persons Diagnosed With and Either Treated or Mon… (NCT02836522) | Clinical Trial Compass
CompletedNot Applicable
Validation of a Health-Related Symptom Index for Persons Diagnosed With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions (HSIL)
United States406 participantsStarted 2016-04-25
Plain-language 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.
Who can participate
Age range35 Years
SexALL
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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 o…
What they're measuring
1
degree of test-retest reliability in the ANCHOR HRSI