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

Memorial Sloan Kettering Cancer Center4 sites in 1 country406 target enrollmentApril 25, 2016

ConditionsAnal High-Grade Squamous Intraepithelial Lesions

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anal High-Grade Squamous Intraepithelial Lesions
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 406
Locations: 4
Primary Endpoint: degree of test-retest reliability in the ANCHOR HRSI
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 25, 2016

End Date

August 31, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility 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.
•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.