Improving Diversity Participation and Enrollment in Cancer Clinical Trials, ECOG-ACRIN SUPPORT Trial

Active:	Yes
Cancer Type:	Solid Tumor	NCT ID:	NCT06756607
Trial Phases:		Protocol IDs:	EAQ223 (primary) EAQ223 ECOG-ACRIN-EAQ223 NCI-2023-05092
Eligibility:	18 Years and older, Male and Female	Study Type:	Supportive care
Study Sponsor:	ECOG-ACRIN Cancer Research Group
NCI Full Details:	http://clinicaltrials.gov/show/NCT06756607

Summary

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.

Objectives

PRIMARY OBJECTIVE:
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.

Treatment Sites in Georgia

Nancy N. and J.C. Lewis Cancer Research Pavilion at St. Joseph Candler
225 Candler Drive
Savannah, GA 31405
912-819-5778
www.sjchs.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.