SURGE: Supporting Utility and Representation in Genomics-based Cancer Trial Enrollment (Intervention)

Nadine Jackson, MD, MPH210 enrolled

Overview

SURGE aims to increase representation 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.

Supporting Utility and Representation 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

210

Conditions

Gastrointestinal Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult (age 18 years or older) * Scheduled for a new patient consultation * Suspected or confirmed advanced malignancy (requiring active treatment) * DFCI patient at Longwood/Chestnut Hill, DFCI satellite at BMC-Brighton (formerly St. Elizabeth's Medical Center), DFCI satellite at Foxborough, 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, Spanish, Haitian Creole, Russian, Portuguese, Arabic, or Traditional Chinese * Unable to provide consent

Locations (3)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

RECRUITING

Dana-Farber Cancer Institute at St. Elizabeth's Medical Center

Brighton, Massachusetts, United States

RECRUITING

Dana-Farber Cancer Instiute - Merrimack Valley

Methuen, Massachusetts, United States

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Genomic testing uptake

Intervention impact on rate of uptake of genomic testing

Time frame: Up to 90 days of enrollment

Secondary Outcomes

Patient interaction with the intervention

Interaction with each component of the intervention (as appropriate by intervention arm)

Time frame: Up to 30 days of enrollment

Acceptability of questionnaire modality

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.