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

Nadine McCleary, MD, MPH

Status: Enrolling

Conditions: Hematologic Cancer; Gastrointestinal Cancer; Thoracic Cancer

Treatments: Behavioral: SURGE

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05375643

21-709

Details and patient eligibility

About

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.

Full description

Supporting UnderRepresented populations in Genomics-based cancer trial Enrollment (SURGE) is a multimodal intervention to address medical literacy and unmet social determinants of health (SDoH) needs as barriers to tumor somatic genomic testing consent among historically underrepresented patients (HUP) diagnosed with advanced solid or hematologic malignancies as a prerequisite to precision therapies and/or clinical trial eligibility. Our key hypothesis is that video-based education with or without 1:1 patient navigation will address medical literacy and unmet SDoH barriers, supporting HUP decision-making about genomic tumor consent. We will conduct a type 1 hybrid implementation effectiveness study among a cohort of HUP seeking medical oncology care at two academic and two community practice sites.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (age 18 years or older)
• Black, Latinx, OR older adult (age 70 years or older)
• Scheduled for a new patient consultation
• Suspected or confirmed advanced malignancy (requiring active treatment)
• Gastrointestinal, hematologic, or thoracic cancer
• DFCI patient at Longwood/Chestnut Hill, DFCI satellite at St. Elizabeth's Medical Center, or DFCI satellite at Merrimack Valley

Exclusion criteria

• Malignancy or former malignancy that requires only surveillance
• Not continuing care at a participating DFCI site
• Speaks a language other than English or Spanish
• Unable to provide consent

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 3 patient groups

Arm B (informational video)

Experimental group

Description:

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

Treatment:

Behavioral: SURGE

Arm A (standard of care)

No Intervention group

Description:

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

Arm C (informational video and patient navigation)

Experimental group

Description:

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

Treatment:

Behavioral: SURGE