Anal High-Grade Squamous Intraepithelial Lesions
Conditions
Keywords
Health-Related Symptom Index, ANCHOR( ANal Cancer HSIL (high grade squamous intraepithelial lesions) Outcomes Research study)
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.
Interventions
BEHAVIORALAssessment of Health-Related Quality
Demographic Questionnaire, ANCHOR HRSI, FACT-G, MDASI, Patient ECOG PS, PGIC
Sponsors
The City College of New York
Northwestern University
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| degree of test-retest reliability in the ANCHOR HRSI | 7-10 days | measure from the initial assessment point to the 7-10 day follow-up. |
Countries
United States
Outcome results
None listed