Various Cancer Types

EAQ223 / SUPPORT



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

United States
AR
Jonesboro
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Contact: Site Public Contact
Email: Emily.Carvell@bmhcc.org

IL
Aurora
Rush - Copley Medical Center
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com

Barrington
Advocate Good Shepherd Hospital
Contact: Site Public Contact

Bloomington
Carle BroMenn Outpatient Center
Contact: Site Public Contact
Email: Research@Carle.com

Chicago
Advocate Illinois Masonic Medical Center
Contact: Site Public Contact

Crystal Lake
AMG Crystal Lake - Oncology
Contact: Site Public Contact
Email: advocateresearch@advocate.com

Danville
Carle at The Riverfront
Contact: Site Public Contact
Email: Research@Carle.com

Downers Grove
Advocate Good Samaritan Hospital
Contact: Site Public Contact
Email: Barbara.barhamand@advocatehealth.com

Effingham
Carle Physician Group-Effingham
Contact: Site Public Contact
Email: Research@carle.com

Elgin
Advocate Sherman Hospital
Contact: Site Public Contact

Hazel Crest
Advocate South Suburban Hospital
Contact: Site Public Contact

Libertyville
AMG Libertyville - Oncology
Contact: Site Public Contact
Email: advocateresearch@advocatehealth.com

Condell Memorial Hospital
Contact: Site Public Contact
Email: advocateresearch@advocatehealth.com

Mattoon
Carle Physician Group-Mattoon/Charleston
Contact: Site Public Contact
Email: Research@carle.com

Normal
Carle BroMenn Medical Center
Contact: Site Public Contact
Email: Research@Carle.com

Carle Cancer Institute Normal
Contact: Site Public Contact
Email: Research@Carle.com

Oak Lawn
Advocate Christ Medical Center
Contact: Site Public Contact

Advocate Outpatient Center - Oak Lawn
Contact: Site Public Contact
Email: ncorp@aah.org

Park Ridge
Advocate Lutheran General Hospital
Contact: Site Public Contact

Urbana
Carle Cancer Center
Contact: Site Public Contact
Email: Research@carle.com

Yorkville
Rush-Copley Healthcare Center
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com

MS
Columbus
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

Grenada
Baptist Cancer Center-Grenada
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

New Albany
Baptist Memorial Hospital and Cancer Center-Union County
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

Oxford
Baptist Memorial Hospital and Cancer Center-Oxford
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

Southhaven
Baptist Memorial Hospital and Cancer Center-Desoto
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

NY
Bronx
Montefiore Medical Center - Moses Campus
Contact: Site Public Contact
Email: eskwak@montefiore.org

Montefiore Medical Center-Einstein Campus
Contact: Site Public Contact
Email: eskwak@montefiore.org

PA
Danville
Geisinger Medical Center
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Hazleton
Geisinger Medical Center-Cancer Center Hazleton
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Wilkes-Barre
Geisinger Wyoming Valley/Henry Cancer Center
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

TN
Collierville
Baptist Memorial Hospital and Cancer Center-Collierville
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

VA
Mechanicsville
Bon Secours Memorial Regional Medical Center
Contact: Site Public Contact
Email: anne_carmellat@bshsi.org

Midlothian
Bon Secours Saint Francis Medical Center
Contact: Site Public Contact
Email: anne_carmellat@bshsi.org

Bon Secours Westchester Emergency Center
Contact: Site Public Contact
Email: anne_carmellat@bshsi.org

Richmond
Bon Secours Cancer Institute at Reynolds Crossing
Contact: Site Public Contact
Email: Anne_caramella@bshsi.org

Bon Secours Richmond Community Hospital
Contact: Site Public Contact
Email: anne_carmellat@bshsi.org

Bon Secours Saint Mary's Hospital
Contact: Site Public Contact
Email: anne_carmellat@bshsi.org

WI
Burlington
Aurora Cancer Care-Southern Lakes VLCC
Contact: Site Public Contact
Email: ncorp@aurora.org

Cudahy
Aurora Saint Luke's South Shore
Contact: Site Public Contact
Email: ncorp@aurora.org

Germantown
Aurora Health Care Germantown Health Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Grafton
Aurora Cancer Care-Grafton
Contact: Site Public Contact
Email: ncorp@aurora.org

Green Bay
Aurora BayCare Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Kenosha
Aurora Cancer Care-Kenosha South
Contact: Site Public Contact
Email: ncorp@aurora.org

Marinette
Aurora Bay Area Medical Group-Marinette
Contact: Site Public Contact
Email: ncorp@aurora.org

Milwaukee
Aurora Cancer Care-Milwaukee
Contact: Site Public Contact
Email: ncorp@aurora.org

Aurora Saint Luke's Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Aurora Sinai Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Contact: Site Public Contact
Email: ncorp@aurora.org

Racine
Aurora Cancer Care-Racine
Contact: Site Public Contact
Email: ncorp@aurora.org

Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Contact: Site Public Contact
Email: ncorp@aurora.org

Summit
Aurora Medical Center in Summit
Contact: Site Public Contact
Email: ncorp@aurora.org

Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Contact: Site Public Contact
Email: ncorp@aurora.org

Wauwatosa
Aurora Cancer Care-Milwaukee West
Contact: Site Public Contact
Email: ncorp@aurora.org

West Allis
Aurora West Allis Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org

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.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its NCI Community Oncology Research Program (NCORP).


ECOG-ACRIN Cancer Research Group