Clinical trial · Observational
Validation of a Health-Related Symptom Index for Persons Diagnosed With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions (HSIL)
NCT02836522CI-TRIAL-00069270completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal High-Grade Squamous Intraepithelial Lesions | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assessment of Health-Related Quality | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- degree of test-retest reliability in the ANCHOR HRSI
- timeFrame
- 7-10 days
- description
- measure from the initial assessment point to the 7-10 day follow-up.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDBurkhalter 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. PMID 30098677