Clinical trial 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)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anal High-Grade Squamous Intraepithelial Lesions
Keywords: Health-Related Symptom Index
ANCHOR( ANal Cancer HSIL (high grade squamous intraepithelial lesions) Outcomes Research study)
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: The City College of New York
name: Northwestern University
First posted: 2016-07-19
Enrollment: 406
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participating ANCHOR sites

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.


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.

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.

Primary outcomes:
measure: degree of test-retest reliability in the ANCHOR HRSI
timeFrame: 7-10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: New York
country: United States
facility: Memorial Sloan - Kettering Cancer Center
state: New York
city: New York
country: United States
facility: City College of New York
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital-Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Thomas Atkinson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burkhalter JE, Atkinson TM, Berry-Lawhorn J, Goldstone S, Einstein MH, Wilkin TJ, Lee J, Cella D, Palefsky JM; ANCHOR HRQOL Implementation Group. Initial Development and Content Validation of a Health-Related Symptom Index for Persons either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions. Value Health. 2018 Aug;21(8):984-992. doi: 10.1016/j.jval.2018.01.018. Epub 2018 Apr 11.