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NCT Number: NCT06756607

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

SUPPORT toolkit

Other

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

Primary outcomes

  1. Participant Referral

    Time frame: 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 outcomes

  1. Participant Accrual

    Time frame: 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

Other outcomes

  1. Provider Referral

    Time frame: 12 months after the intervention

    Change in provider referral behavior assessed at 12 months after the intervention

  2. Provider Perceptions of Clinical Trials

    Time frame: 12 months after the intervention

    Change in provider perceptions of clinical trials assessed at 12 months after the intervention

  3. Exploratory outcome

    Time frame: 12 months after the intervention

    Participant referral by provider assessed at 12 months after the intervention and participant referral by clinic site assessed at 12 months after the intervention

  4. Exploratory outcome

    Time frame: 12 months after the intervention

    CUSP2CT selected common measures of (a) Participant CT Awareness and Knowledge and (b) Provider CT Awareness and Knowledge

Study contacts

Contact information is provided by the study sponsor or research team.

Elyse R Park, PhD, MPH

CONTACT

[email protected]

(617) 724-6836

Melissa A Simon, MD, MPH

CONTACT

[email protected]

(312) 503-8780

Sponsors and collaborators

Lead sponsor

Eastern Cooperative Oncology Group

Network

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 3, 2025
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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