SURGE: Supporting UnderRepresented Minorities in Genomics-based Cancer Trial Enrollment (Intervention)

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Nadine McCleary, MD, MPH
Study ID
NCT05375643
Status
Recruiting

Conditions

  • Gastrointestinal Cancer
  • Hematologic Cancer
  • Thoracic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SURGE — BEHAVIORAL
    Video with or without person to person guidance to support decision making around genetic testing

Study Details

SURGE aims to increase equity in clinical trial enrollment by addressing barriers to genomic testing, which is increasingly needed to assess precision clinical trial eligibility and access standard precision therapies. The study is an interventional pilot meant primarily to assess the feasibility of the intervention. The intervention is comprised of a patient navigator, text message questionnaire, and informational video.

Key Dates

Start date
Apr 3, 2023
Status verified
Sep 2025
Primary completion
Dec 30, 2027
Completion
Jul 30, 2028

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Arm B (informational video)
    Participants will complete screening questionnaire via text or by phone to establish baseline awareness and interest in clinical trials and then randomized to the SURGE intervention where they will receive: * Informational Video
  • No Intervention: Arm A (standard of care)
    Participants will complete screening questionnaire via text or by phone to establish baseline awareness and interest in clinical trials and then randomized to Standard of Care (SOC) and receive: * Standard of Care
  • Experimental: Arm C (informational video and patient navigation)
    Participants will complete screening questionnaire via text or by phone to establish baseline awareness and interest in clinical trials and then randomized to the SURGE intervention where they will receive: * Informational Video and Patient Navigation

Primary Outcome Measure

Genomic testing uptake [ Time Frame: Up to 90 days of enrollment ]

Central Contacts

  • Nadine J McCleary, MD MPH
    (617) 632-6729
  • Nadine J McCleary, MD MPH
    (617) 632-6729

Locations (3)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215
Nadine J. McCleary, MD, MPH
(617) 632-6729
Nadine J. McCleary, MD, MPH (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer Institute at St. Elizabeth's Medical CenterBrightonMassachusetts02135
Olga Kozyreva, MD
Olga Kozyreva, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer Instiute - Merrimack ValleyMethuenMassachusetts01844
Pedro Sanz-Altamira, MD
Pedro Sanz-Altamira, MD (PRINCIPAL_INVESTIGATOR)

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