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

NCT06756607 | Recruiting DMC

• 3 other identifiers: EAQ223ECOG-ACRIN-EAQ223NCI-2023-05092
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Participant Accrual

  End of 12 months

Other Outcomes (4)

• Provider Referral

  12 months after the intervention

• Provider Perceptions of Clinical Trials

  12 months after the intervention

• Exploratory outcome

  12 months after the intervention

Study Arms (2)

Control

NO INTERVENTION

Participant will receive usual care

Intervention

EXPERIMENTAL

Participant will receive intervention and receive the SUPPORT toolkit.

Other: SUPPORT toolkit

Interventions

SUPPORT toolkit OTHER

The SUPPORT toolkit comprises of the SUPPORT CT website and interaction with a SUPPORT navigator.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Melissa A Simon, MD, MPH

  Eastern Cooperative Oncology Group

  STUDY CHAIR

Central Study Contacts

Melissa A Simon, MD, MPH

CONTACT

(312) 503-8780; m-simon2@northwestern.edu

Elyse R Park, PhD, MPH

CONTACT

(617) 724-6836; epark@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: January 3, 2025
• Study Start: April 25, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)