NCT02836522

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
406

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

7.4 years

First QC Date

July 12, 2016

Last Update Submit

August 31, 2023

Conditions

Anal High-Grade Squamous Intraepithelial Lesions

Keywords

Health-Related Symptom IndexANCHOR( ANal Cancer HSIL (high grade squamous intraepithelial lesions) Outcomes Research study)

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Assessment of Health-Related QualityBEHAVIORAL

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

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

participating ANCHOR sites

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Northwestern University

Evanston, Illinois, 60208, United States

Location

Memorial Sloan - Kettering Cancer Center

New York, New York, 10021, United States

Location

City College of New York

New York, New York, 10031, United States

Location

New York Presbyterian Hospital-Weill Medical College of Cornell University

New York, New York, 10065, United States

Location

Related Publications (1)

  • 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.

    PMID: 30098677DERIVED

Related Links

MeSH Terms

Conditions

Squamous Intraepithelial Lesions

Condition Hierarchy (Ancestors)

Morphological and Microscopic FindingsPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Atkinson, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 19, 2016

Study Start

April 25, 2016

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

September 1, 2023

Record last verified: 2023-08

Locations

US(4)