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Completed

NCT Number: NCT02836522

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

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.

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University, Evanston, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Assessment of Health-Related Quality

Behavioral

Demographic Questionnaire, ANCHOR HRSI, FACT-G, MDASI, Patient ECOG PS, PGIC

Primary outcomes

  1. degree of test-retest reliability in the ANCHOR HRSI

    Time frame: 7-10 days

    measure from the initial assessment point to the 7-10 day follow-up.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Northwestern University
  • The City College of New York

Registry information

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2016
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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