Clinical trial NCT06756607: The ECOG-ACRIN SUPPORT Trial: Multilevel Intervention to Improve Diverse Enrollment in Cancer Clinical Trials
Official title: The ECOG-ACRIN SUPPORT Trial: Multilevel Intervention to Improve Diverse Enrollment in Cancer Clinical Trials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
First posted: 2025-01-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Participant Referral
timeFrame: End of 12 months
Secondary outcomes:
measure: Participant Accrual
timeFrame: End of 12 months
Other outcomes:
measure: Provider Referral
timeFrame: 12 months after the intervention
measure: Provider Perceptions of Clinical Trials
timeFrame: 12 months after the intervention
measure: Exploratory outcome
timeFrame: 12 months after the intervention
measure: Exploratory outcome
timeFrame: 12 months after the intervention
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Eastern Cooperative Oncology Group
name: Melissa A Simon, MD, MPH
role: STUDY_CHAIR
References: