Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC

April 18, 2024 updated by: AIDS Malignancy Consortium

Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AIDS Malignancy Consortium A Trial of the AIDS Malignancy Consortium (AMC)

This study is being done to understand how many people with HIV (PWH) present for cancer care across the AIDS Malignancy Consortium in the United States and if there are reasons that some PWH choose to participate, or not in cancer clinical trials. Optional quality of life surveys will be used to learn more about how HIV and cancer and HIV and cancer treatment affect people.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

720

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92903
        • Recruiting
        • Moores UCSD Cancer Center
        • Principal Investigator:
          • Erin Reid, MD
        • Contact:
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Recruiting
        • George Washington University Cancer Center
        • Principal Investigator:
          • Sharad Goyal, MD
        • Contact:
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
        • Principal Investigator:
          • Anna Coghill, MD
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois at Chicago
        • Principal Investigator:
          • Paul Rubinstein, MD
        • Contact:
          • Richard Shi
          • Phone Number: 312-996-9734
          • Email: yshi@uic.edu
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Recruiting
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
        • Principal Investigator:
          • Richard Ambinder, MD
        • Contact:
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Lee Ratner, MD, PhD
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
        • Principal Investigator:
          • Rafi Kabaritti, MD
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
        • Principal Investigator:
          • Keith Siegel, MD
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Contact:
        • Principal Investigator:
          • Gretchen McNally, APRN, CNP
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Elizabeth Chiao, MD, MPH
    • Washington
      • Seattle, Washington, United States, 98101
        • Recruiting
        • Virginia Mason Medical Center
        • Principal Investigator:
          • David Aboulafia, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with a dual diagnosis of both cancer (current or diagnosed within 5 years) and underlying HIV infection, who present for care at AMC domestic sites.

Description

Inclusion Criteria:

  • Participant can understand and is willing to sign a written informed consent document.

  • HIV positive. Documentation of HIV-1 infection by means of any one of the following:

    • Documentation of an HIV diagnosis in the medical record by a licensed health care provider;
    • Documentation of receipt of antiretroviral therapy (ART) (i.e., at least two different medications that do not constitute a prescription for pre-exposure prophylaxis [PrEP]) by a licensed health care provider. Documentation may be a record of an ART prescription in the medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name;
    • HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating >1000 RNA copies/mL;
    • Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay.

Note: The term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally (e.g., U.S. FDA).

WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay, or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), a Western blot, or a plasma HIV-1 RNA viral load.

  • Patient was diagnosed with or treated for cancer within the last 5 years. Participants will qualify under one of three categories:

    • New, primary or recurrent diagnosis -Considering or currently receiving cancer treatment
    • Metastatic or locally advanced cancer - This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
    • Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
  • Age ≥ 18 years.
  • Participant presents to an AMC domestic clinical trial site for either clinical care or research.

Exclusion Criteria:

  • Participants who do not fulfill the criteria as listed above are ineligible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
New, primary or recurrent disease
Considering or currently receiving cancer treatment
Other: Non-Interventional
Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Other: Non-Interventional Follow-up
Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
Metastic or locally advanced cancer
This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
Other: Non-Interventional
Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Other: Non-Interventional Follow-up
Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
Prior cancer
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
Other: Non-Interventional
Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cancers in people with HIV (PWH) who present for care at domestic AMC sites
Time Frame: Enrollment

For each cancer group listed below, the number of new and existing cases per month will be estimated. The distribution of cancer types will be computed as percentages and compared to the cancer type distribution in the HIV/AIDS Cancer Match (HACM) Study:

  1. Solid organ tumors associated with human papillomavirus (HPV) infection
  2. Solid organ tumors unrelated to HPV
  3. Kaposi sarcoma
  4. Hematologic malignancies
Enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants eligible for AMC trials who are successfully enrolled
Time Frame: Baseline and 12 weeks
This will be calculated by the number of participants enrolled who meet site-based AMC trial eligibility compared to the number of eligible participants at each site who meet site-based AMC trial eligibility.
Baseline and 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the sociodemographic, HIV-related, and cancer diagnostic and treatment characteristics of cancer patients with HIV receiving care at domestic AMC sites.
Time Frame: Baseline and 12 weeks
The distribution of participant characteristics will be summarized. Continuous variables [e.g. age, height, weight] will be summarized as mean (std) if they are normally distributed, otherwise they will be summarized as median (IQR). Categorical variables [e.g. tobacco use, ART medications, comorbidities] will be summarized as frequency (%).
Baseline and 12 weeks
Describe the health-related QOL of cancer patients with HIV at domestic AMC sites using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]
Time Frame: Baseline
EORTC QLQ-C30 subscale and overall scores will be used to describe participant symptom and health-related quality of life burden. Baseline EORTC QLQ-C30 scores will be compared according to successful enrollment versus not. The EORTC QLQ-C30 is a 30-item core cancer specific questionnaire measuring QOL in cancer patients. It incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and single items assessing additional symptoms and perceived financial impact of the disease. Most questions use a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions use a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=higher response level.
Baseline
Describe the supportive care needs of cancer patients with HIV at domestic AMC sites using Supportive Care Needs Survey Short Form 34 [SCNS-SF34]
Time Frame: Baseline
Supportive Care Needs Survey Short Form 34 [SCNS-SF34] scores will be used to categorize participants based on the degree to which their needs are met. Baseline SCNS-SF34 scores will be compared according to successful enrollment versus not. The SCNS-SF34 is a 34-item questionnaire measuring the supportive care need and level of need for people diagnosed with cancer in the last month. It incorporates the underlying domains: physical and daily living, psychological, sexuality and health system, information and patient support. All the questions use 5-point scale (1 'Not applicable' to 5 'High need); with a higher score indicating a higher level of need.
Baseline
Change of Quality of Life at 12 Weeks From Baseline for cancer patients with HIV initiating therapy or currently under treatment using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]
Time Frame: Baseline and 12 weeks
EORTC QLQ-C30 will be summarized, both overall and at the ~12-week follow-up, according to participant characteristics and cancer groups. Overall change in QOL will be compared with paired tests and change according to groups will be compared using t-tests, ANOVA, or nonparametric tests. The EORTC QLQ-C30 is a 30-item core cancer specific questionnaire measuring QOL in cancer patients. It incorporates five functional scales (physical, role,cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms and perceived financial impact of the disease. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=higher response level.
Baseline and 12 weeks
Change of needs from baseline for cancer patients with HIV initiating therapy or currently under treatment using Supportive Care Needs Short Survey Form 34 [SCNS-SF34]
Time Frame: Baseline and 12 weeks
Supportive Care Needs Short Survey Form 34 [SCNS-SF34] scores will be summarized, both overall and at the ~12-week follow-up, according to participant characteristics and cancer groups. Overall change in scores will be compared with paired tests and change according to groups will be compared using t-tests, ANOVA, or nonparametric tests. The SCNS-SF34 is a 34-item questionnaire measuring the supportive care need and level of need for people diagnosed with cancer in the last month. It incorporates the underlying domains: physical and daily living, psychological, sexuality and health system, information and patient support. All the questions use 5-point scale (1 'Not applicable' to 5 'High need). Scores are averaged, and transformed to 0-100 scale;, with a higher score indicating a higher level of need.
Baseline and 12 weeks
3. State of planned cancer therapy for cancer patients with HIV initiating therapy or currently under treatment
Time Frame: 12 weeks
The frequency of planned cancer treatment regimens (at baseline) successfully initiated will be summarized.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AIDS Malignancy Consortium

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2023

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

August 1, 2022

First Submitted That Met QC Criteria

August 18, 2022

First Posted (Actual)

August 22, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC-115
  • UM1CA121947 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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