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Improving Diversity Participation and Enrollment in Cancer Clinical Trials, ECOG-ACRIN SUPPORT Trial
Trial Status: active
This early phase I trial tests how to improve diversity in participation and enrollment in cancer clinical trials. Inadequate diversity in clinical trials is widely recognized as a significant contributing factor to health disparities experienced by racial/ethnic minorities and other diverse populations in the United States. This disparity calls for urgent initiatives aimed at increasing diversity to support more equitable representation in clinical research and bring the benefits of advances in healthcare forged by clinical research equitably to all. National Cancer Institute (NCI) supported clinical trials (CTs) are key drivers of innovations in cancer care; however racial/ethnic minorities, and Black and Latino populations in particular, are underrepresented in NCI-supported CTs and thus not able to fully benefit from cutting edge treatments and precision medicine. CT participation among Black and Latino populations continues to fall short and the multitude of structural, clinical, physician, and patient barriers warrant multilevel interventions to enhance referral and enrollment of Black and Latino patients to NCI-supported CTs. Engaging a diverse population of patients to enroll in cancer clinical trials requires the active participation of referring clinicians and oncologists. Referring physicians play an important role in facilitating patient access to CTs; however, they often have little knowledge about cancer CTs and often do not present this treatment option to patients. The multilevel SUPPORT intervention, consisting of a CT research literacy tool and CT resource navigators may have the potential to increase referral and accrual of Black and Latino cancer patients to NCI-supported CTs.
Inclusion Criteria
PROVIDERS: Participant must be a provider who specializes in medical oncology, surgery, or radiation oncology.
PROVIDERS: Participant must be employed at one of the participating NCORP sites.
PATIENTS: Participant must be >= 18 years of age.
PATIENTS: Participant must self-identify as Black and/or Latino.
PATIENTS: Participant must be an oncology patient at a participating NCORP.
PATIENTS: Participant must be presumed eligible (e.g. at the chart level screening) to participate in an NCI-supported clinical trial.
PATIENTS: Participant must have the ability to understand and the willingness to sign a e-consent document.
PATIENTS: Participant must be receiving care at a participating NCORP affiliated community oncology site
PATIENTS: Participant must be English or Spanish speaking
PATIENTS: Participant must have access to a landline, smartphone, computer, or tablet.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06756607.
Locations matching your search criteria
United States
Arkansas
Jonesboro
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
I. Conduct a Hybrid Type 1 cluster-randomized, roll-out effectiveness-implementation trial in NCI Community Oncology Research Program (NCORP) community oncology practice sites (N= 500 Black and Latino cancer patients) to evaluate the effectiveness of the EA SUPPORT intervention combining CT navigators and CT research literacy tools in increasing Black and Latino patient referral (primary outcome) and accrual (secondary
outcome) to NCI-supported CTs. (Phase II)
SECONDARY OBJECTIVES:
II. Increase participant and provider awareness and knowledge of CTs (exploratory outcomes) while assessing implementations factors.
III. With the Connecting Underrepresented Populations to Clinical Trials (CUSP2CT) data, evaluation, and coordinating center, conduct final site evaluation and disseminate the SUPPORT intervention to NCORP community oncology sites, research bases, and affiliated trial networks. (Phase III)
EXPLORATORY OBJECTIVE:
I. Exploratory outcomes include change in provider referral behavior -, change in provider perceptions of clinical trials, participant referral by provider and participant referral by clinic site, and CUSP2CT selected common measures of:
Ia. Participant CT Awareness and Knowledge; and
Ib. Provider CT Awareness and Knowledge, assessed at 12 months after the intervention.
OUTLINE: NCORP sites are cluster randomized to 1 of 3 waves to stagger the timing of the start of the SUPPORT intervention on study.
STAGE I (BASELINE CONTROL PERIOD): NCORP sites complete a 4-month baseline usual care control period to support sites in preparing for intervention implementation.
STAGE II (SITE IMPLEMENTATION): NCORP sites participate in SUPPORT intervention over 12 months. Champions and site implementation teams provide the SUPPORT CT Literacy Tool: Health for All website and SUPPORT CT Resource Navigators to patients on study. SUPPORT navigators implement trainings and checklist-based CT referral prompts to NCI-supported CTs for providers and site-based CT recruiters, connect site-based CT staff with resources and support identifying potential CT participants, and identify and address patient-level social determinants of health (SDoH) barriers to cancer CTs. Providers receive CT checklists with specific action items for CT participation. Patients receive CT pocket card with the link to the SUPPORT CT Literacy website and contact information of the SUPPORT navigator.
STAGE III (SUSTAINABILITY & POST-INTERVENTION ASSESSMENTS): Patients and providers complete surveys and may complete an interview at 12 and 18 months post SUPPORT intervention.
