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

Anal High-Grade Squamous Intraepithelial Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836522
• Other study ID #: 16-282
• Status: Completed
• Start date: April 25, 2016
• Est. completion date: August 31, 2023

Study information

• Verified date: August 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anal High-Grade Squamous Intraepithelial Lesions
• Carcinoma in Situ
• Carcinoma, Squamous Cell
• Squamous Intraepithelial Lesions of the Cervix

Intervention

Behavioral:
• Assessment of Health-Related Quality
Demographic Questionnaire, ANCHOR HRSI, FACT-G, MDASI, Patient ECOG PS, PGIC

Locations

Country	Name	City	State
United States	Northwestern University	Evanston	Illinois
United States	City College of New York	New York	New York
United States	Memorial Sloan - Kettering Cancer Center	New York	New York
United States	New York Presbyterian Hospital-Weill Medical College of Cornell University	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Northwestern University, The City College of New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	degree of test-retest reliability in the ANCHOR HRSI	measure from the initial assessment point to the 7-10 day follow-up.	7-10 days

External Links

•   Memorial Sloan Kettering Cancer Center