Development of a Health-Related Symptom Index for Participants With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions

NCT04276935 | Completed Results

• 4 other identifiers: AMC-A04UM1CA121947U54CA137788NCI-2018-01740
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 4

Brief Summary

This trial develops a health-related symptom index for participants with and either treated or monitored for anal high-grade squamous intraepithelial lesions. The health-related quality of life index may help to capture the symptoms and related experiences of living with or being treated for high-grade squamous intraepithelial lesions.

Conditions

High Grade Anal Canal Squamous Intraepithelial Neoplasia; Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• Development of Spanish-language Version of the Anal Cancer/High-grade Squamous Intraepithelial Lesions (HSIL) Outcomes Research (ANCHOR) Health-related Quality of Life (HRQoL) Index-Round 1 and Round 2

  Participants completed A-HRSI, as aurally administered over telephone to indicate whether there were any items or aspects of the instructions that were difficult to understand, and then complete a process of retrospective probing. Summary reports from the Round 1 interview were coded to highlight any instances where a participant indicated that they experienced difficulty with an item or concept within an item. For any item that was reported by at least three participants as difficult for any reason, that item or concept was reviewed to determine whether the difficulty was due to (1) the concept being measured or (2) a translation issue (i.e., register, jargon, or regionalism). These items were revised during a research team panel discussion and used in Round 2 interviews with additional eligible participants. A similar process was used for Round 2.

  45-60 minutes during the telephone call in each round.

Study Arms (1)

Health Services Research (cognitive interviews)

Participants take part in cognitive interviews in Spanish over 45-60 minutes.

Other: Interview; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Interview OTHER

Participate in cognitive interview

Health Services Research (cognitive interviews)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Health Services Research (cognitive interviews)

Questionnaire Administration OTHER

Ancillary studies

Health Services Research (cognitive interviews)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-infected adult men and women with biopsy-proven anal HSIL that was treated in the last 9 months, and who are fluent in Spanish with limited English proficiency.

You may qualify if:

• Human immunodeficiency virus (HIV)-1 infection.
• Biopsy-proven anal HSIL within the prior nine months.
• Participant must have received anal HSIL treatment in the last nine months. If the participant's treatment plan is observation? the participant must have been diagnosed with anal HSIL in the last nine months.
• Life expectancy of greater than 5 years.
• Fluent in Spanish with limited English proficiency, per self-report.

You may not qualify if:

• History of anal cancer.
• Inability to understand a written consent form.

Sponsors & Collaborators

• AIDS Malignancy Consortium: lead
• National Cancer Institute (NCI): collaborator
• Memorial Sloan Kettering Cancer Center: collaborator
• The Emmes Company, LLC: collaborator

Study Sites (4)

University of California - San Francisco

San Francisco, California, 94143, United States

Location

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Anal Dysplasia Clinic MidWest

Chicago, Illinois, 60614, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Thomas M. Atkinson
• Organization: Memorial Sloan Kettering Cancer Center

atkinsot@mskcc.org

646-888-0089

Study Officials

• Thomas Atkinson

  AIDS Malignancy Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: February 19, 2020
• Study Start: November 6, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 7, 2025
• Results First Posted: November 18, 2023

Record last verified: 2025-03

Locations

US (4)