The ECOG-ACRIN SUPPORT Trial: Multilevel Intervention to Improve Diverse Enrollment in Cancer Clinical Trials

The purpose of this study is to conduct a Hybrid Type 1 cluster-randomized, roll-out effectiveness-implementation trial in 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 improving Black and Latino patient referral and accrual to NCI-supported CTs (primary outcomes) and participant and provider awareness and knowledge of CTs (secondary outcomes) while assessing implementation factors. Also, with the 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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: SUPPORT toolkit

Detailed Description

The purpose of this study is to conduct a Hybrid Type 1 cluster-randomized, roll-out effectiveness-implementation trial in 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 improving Black and Latino patient referral and accrual to NCI-supported CTs (primary outcomes) and participant and provider awareness and knowledge of CTs (secondary outcomes) while assessing implementation factors. Also, with the 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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa A Simon, MD, MPH; Phone Number: (312) 503-8780; Email: m-simon2@northwestern.edu
• Study Contact Backup: Name: Elyse R Park, PhD, MPH; Phone Number: (617) 724-6836; Email: epark@mgh.harvard.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Participant must be ≥ 18 years of age. Participant must self-identify as Black and/or Latino. Participant must be an oncology patient at a participating NCORP. Participant must be eligible to participate in an ECOG-ACRIN clinical trial. Participant must have the ability to understand and the willingness to sign a e-consent document.

Participant must be receiving care at a participating NCORP affiliated community oncology site.

Participant must be English or Spanish speaking to be eligible. Participant must have access to a landline, smartphone, computer, or tablet.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participant will receive usual care
Experimental: Intervention; Participant will receive intervention and receive the SUPPORT toolkit.	Other: SUPPORT toolkit; The SUPPORT toolkit comprises of the SUPPORT CT website and interaction with a SUPPORT navigator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Referral	Participant referral to any NCI-supported CT assessed at the end of the 12 months of intervention stage, which will be collected from the referral tracking sheet during the intervention	End of 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Accrual	Participant accrual assessed at the end of the 12 months of intervention stage, as abstracted from the clinical trials management system and corroborated with abstracted medical records and providers' clinical notes	End of 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory outcome	Participant referral by provider assessed at 12 months after the intervention and participant referral by clinic site assessed at 12 months after the intervention	12 months after the intervention
Exploratory outcome	CUSP2CT selected common measures of (a) Participant CT Awareness and Knowledge and (b) Provider CT Awareness and Knowledge	12 months after the intervention
Provider Referral	Change in provider referral behavior assessed at 12 months after the intervention	12 months after the intervention
Provider Perceptions of Clinical Trials	Change in provider perceptions of clinical trials assessed at 12 months after the intervention	12 months after the intervention

Collaborators and Investigators

• Sponsor: Eastern Cooperative Oncology Group
• Investigators: Study Chair: Melissa A Simon, MD, MPH, Eastern Cooperative Oncology Group

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: December 30, 2024
• First Posted (Actual): January 3, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: EAQ223; ECOG-ACRIN-EAQ223 (Other Identifier: DCP); NCI-2023-05092 (Other Identifier: NCI CTRP)

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
• product manufactured in and exported from the U.S.: No