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

Completed

• Conditions: Anal High-Grade Squamous Intraepithelial Lesions

• Registration Number: NCT02836522
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-25
• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-19
• Status Verified: 2023-08
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 406

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

Memorial Sloan - Kettering Cancer Center; 🇺🇸 New York, New York, United States

City College of New York; 🇺🇸 New York, New York, United States

New York Presbyterian Hospital-Weill Medical College of Cornell University; 🇺🇸 New York, New York, United States

Northwestern University; 🇺🇸 Evanston, Illinois, United States