SURGE: Supporting UnderRepresented Minorities in Genomics-based Cancer Trial Enrollment (Intervention)
- Conditions
- Gastrointestinal CancerThoracic CancerHematologic Cancer
- Interventions
- Behavioral: SURGE
- Registration Number
- NCT05375643
- Lead Sponsor
- Nadine McCleary, MD, MPH
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 210
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm C (informational video and patient navigation) SURGE 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 Arm B (informational video) SURGE 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
- Primary Outcome Measures
Name Time Method Genomic testing uptake Up to 90 days of enrollment Intervention impact on rate of uptake of genomic testing
- Secondary Outcome Measures
Name Time Method Patient interaction with the intervention Up to 30 days of enrollment Interaction with each component of the intervention (as appropriate by intervention arm)
Acceptability of questionnaire modality Up to 30 days of enrollment We will use the System Usability Scale to measure usability of the questionnaire electronic tool. The 10-item System Usability Scale is scored on a five-point Likert scale, with 1 being Strongly Disagree and 5 being Strongly Agree.
Trial Locations
- Locations (3)
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute at St. Elizabeth's Medical Center
🇺🇸Brighton, Massachusetts, United States
Dana-Farber Cancer Instiute - Merrimack Valley
🇺🇸Methuen, Massachusetts, United States