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 Center (MSK)

Status: Completed

Conditions: Anal High-Grade Squamous Intraepithelial Lesions

Treatments: Behavioral: Assessment of Health-Related Quality

Study type: Observational

Funder types: Other

Identifiers

NCT02836522

16-282

Details and patient eligibility

About

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.

Enrollment: 406 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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.

Trial design