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.
Brief Title
The ECOG-ACRIN SUPPORT Trial: Multilevel Intervention to Improve Diverse Enrollment in Cancer Clinical Trials
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
(312) 503-8780
Central Contact Email
m-simon2@northwestern.edu
Central Contact Role
Contact
Central Contact Phone
(617) 724-6836
Central Contact Email
epark@mgh.harvard.edu
Completion Date
Completion Date Type
Estimated
Conditions
Cancer
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:
\-
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:
\-
Inclusion 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.
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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06756607
Org Class
Network
Org Full Name
Eastern Cooperative Oncology Group
Org Study Id
EAQ223
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
The ECOG-ACRIN SUPPORT Trial: Multilevel Intervention to Improve Diverse Enrollment in Cancer Clinical Trials
Primary Outcomes
Outcome Description
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
Outcome Measure
Participant Referral
Outcome Time Frame
End of 12 months
Secondary Ids
Secondary Id
ECOG-ACRIN-EAQ223
Secondary Outcomes
Outcome Description
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
Outcome Time Frame
End of 12 months
Outcome Measure
Participant Accrual
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Bruce Rapkin
Investigator Email
bruce.rapkin@einsteinmed.edu
Investigator Phone
718-920-5663
Investigator Department
Epidemiology & Population Health
Investigator Division
Health Behavior Research & Implementation Science
Study Department
Epidemiology and Population Health
Study Division
Health Behavior Research & Implementation Science
Categories Mesh Debug
Cancer --- NEOPLASMS
MeSH Terms
NEOPLASMS