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

Not Applicable

Recruiting

• Conditions: Cancer

• Registration Number: NCT06756607
• Lead Sponsor: Eastern Cooperative Oncology Group

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-12-30
• Study First Posted: 2025-01-03
• Study Start: 2025-04-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-25
• Primary Completion: 2028-08-01
• Study Completion: 2029-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Participant Referral	End of 12 months	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

Secondary Outcome Measures

Name	Time	Method
Participant Accrual	End of 12 months	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

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States