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

NCT ID: NCT06756607

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-25

Study Completion Date

2029-08-01

Brief Summary

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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

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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

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control

Participant will receive usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Participant will receive intervention and receive the SUPPORT toolkit.

Group Type EXPERIMENTAL

SUPPORT toolkit

Intervention Type OTHER

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

Interventions

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SUPPORT toolkit

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

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eastern Cooperative Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melissa A Simon, MD, MPH

Role: STUDY_CHAIR

Eastern Cooperative Oncology Group

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Melissa A Simon, MD, MPH

Role: CONTACT

Phone: (312) 503-8780

Email: [email protected]

Elyse R Park, PhD, MPH

Role: CONTACT

Phone: (617) 724-6836

Email: [email protected]

Other Identifiers

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ECOG-ACRIN-EAQ223

Identifier Type: OTHER

Identifier Source: secondary_id

EAQ223

Identifier Type: -

Identifier Source: org_study_id