Clinical trial NCT06263088: EQUITY GI: A Prospective Study to Enhance Quality, Inclusivity, and Trial Participation in Black Patients With Gastrointestinal Cancer.
Official title: EQUITY GI: A Prospective Study to Enhance Quality, Inclusivity, and Trial Participation in Black Patients With Gastrointestinal Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Cancer
Colon Cancer
Rectal Cancer
Anal Cancer
Esophageal Cancer
Stomach Cancer
Appendix Cancer
Pancreas Cancer
Liver Cancer
Neuroendocrine Tumors
Keywords: Gastrointestinal cancer
African Americans
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm study to address the existing disparities faced by Black participants with gastrointestinal (GI) cancer in accessing crucial biomarker testing, receiving evidence-based care, and participating in clinical trials.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research study is being conducted to improve the quality of care of participants who have a diagnosis of gastrointestinal cancer (anal, colon, rectal, esophageal, stomach, small bowel, appendix, pancreas, gall bladder, liver, neuroendocrine tumor of gastrointestinal origin).

This study has 3 components as follows-

1. Ensuring appropriate biomarker testing and evidence-based care: Biomarkers are molecules in the tumor or blood that indicate normal or abnormal processes in participant's body and may indicate an underlying condition or disease. Various molecules, such as DNA (genes), proteins, or hormones, can serve as biomarkers since they all indicate something about participant's health. Biomarker testing can also help choose participant's treatment. Additionally, a tumor board will be conducted periodically to provide treatment recommendations to participant's treating physician. Participants will receive standard-of-care treatment if participant enroll in this study. Participant will not receive any experimental treatment.
2. Assistance with clinical trial enrollment. The study team will help participants enroll in a clinical trial appropriate for participant's condition. However, enrolling in a clinical trial is totally up to the participant.
3. Health literacy: The study team will provide information relevant to participant's diagnosis to enrich participant's understanding of participant's condition and treatment. Investigator will provide questionnaires to assess participant's understanding before and after participant's have been provided with educational/informational material appropriate for participant's diagnosis.

Detailed description: Black individuals, including African Americans, have a disproportionate cancer burden, including the highest mortality and the lowest survival of any racial/ethnic group for most cancers.1 Colorectal cancer (CRC), the most common subtype of GI cancer, is the third most frequently diagnosed cancer among Black men and women.1 Black participants have a disproportionate gastrointestinal (GI) tract cancer burden compared with White participants, with a 19% excess risk of cancer death for men and a 13% excess risk for women.2 Almost two decades after the Institute of Medicine's Unequal Treatment report,3 the treatment gap persists among Black participants with GI cancer across treatment settings and modalities.4 A National Cancer Database (NCDB)-based analysis suggests that Black participants with GI cancers are less likely than White participants to achieve negative surgical margins, undergo adequate lymphadenectomies, and less often receive adjuvant therapies.4 Similar data demonstrates racial disparities in care and outcomes in many GI cancer types.5-8 It is important to emphasize that the disparity of cancer care among Black participants shown in the published studies is likely an underestimate given that Black participants are less likely to receive appropriate workups leading to a cancer diagnosis because of the mistrust in the existing system.9 The age-standardized incidence of various GI cancers, including colon, rectal, liver, intrahepatic bile duct, stomach, and pancreatic cancers, is projected to rise in the United States (US) in the coming decades,10 strongly supporting a need for innovative measures to address the care gap. With this proposed project, investigator seeks to address this troubling disparity by assessing the extent of the care gap, expanding the biomarker testing and evidence-based care through the molecular tumor board, and implementing a information platform integrated with EPIC electronic health record system that will guide providers to navigate the biomarker-driven therapy and clinical trial enrollment.

University Hospitals Seidman Cancer Center (UH SCC) is a large hybrid academic-community oncology network that includes the main academic center and 15 community-based cancer centers. At UH SCC, approximately 2000 participants with GI cancer diagnoses are treated annually, and 15 % of these participants are Black. Investigator retrospectively reviewed all cases of CRC, the most prevalent GI cancer, diagnosed in the UH SCC system from April 2020 to March 2022 and found that only 30% of participants underwent all appropriate biomarker testing. Biomarker testing rates were particularly low in community sites. In addition, approximately 15% of participants treated for CRC at UH SCC were underserved minorities, predominantly Black, in whom the rate of biomarker testing was even lower (20%). These data highlight the urgent need for measures to close the care gap. Our colleagues at UH SCC in the thoracic oncology group previously demonstrated the feasibility of improving biomarker testing and implementing biomarker-guided treatment by utilizing an integrated information platform that tracks the biomarker test results.11 Investigator plans to create a similar integrated information platform for GI cancer participants, 'EQUITY GI Oncotracker.'

Eligibility criteria: Inclusion Criteria:

1. Adult ≥ 18 years old.
2. Newly diagnosed Black GI cancer participants irrespective of stage. Eligible tumor types include anal carcinoma, rectal cancer, colon cancer, small bowel cancer, appendix carcinoma, hepatobiliary cancer, pancreatic cancer, gastroesophageal cancer, gastrointestinal neuroendocrine tumors, and gastrointestinal stromal tumor.
3. Patient able and willing to comply with study procedures
4. The patient is able to understand and willing to sign and date the written informed consent form at the screening visit.

Exclusion Criteria:

* NONE

Primary outcomes:
measure: Biomarker testing rate of Black participants diagnosed with GI cancer
timeFrame: 24 months
Secondary outcomes:
measure: Clinical trial enrollment rate among black participants diagnosed with GI cancer
timeFrame: 24 months
measure: Change in Health literacy test among black participants diagnosed with GI cancer
timeFrame: 24 months
measure: Change in Health literacy score among black participants diagnosed with GI cancer
timeFrame: 24 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Sakti Chakrabarti, MD
role: PRINCIPAL_INVESTIGATOR
References: