Gastrointestinal Cancer, Hematologic Cancer, Thoracic Cancer
Conditions
Keywords
Gastrointestinal Cancer, Hematologic Cancer, Thoracic Cancer
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSURGE
Video with or without person to person guidance to support decision making around genetic testing
Sponsors
Nadine Jackson, MD, MPH
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Genomic testing uptake | Up to 90 days of enrollment | Intervention impact on rate of uptake of genomic testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTNadine A Jackson, MD MPH
CONTACTNadine J McCleary, MD MPH
PRINCIPAL_INVESTIGATORNadine A Jackson, MD MPH
Dana-Farber Cancer Institute
Outcome results
None listed