Clinical trial NCT05375643: SURGE: Supporting UnderRepresented Minorities in Genomics-based Cancer Trial Enrollment (Intervention)
Official title: SURGE: Supporting UnderRepresented Minorities in Genomics-based Cancer Trial Enrollment (Intervention)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Cancer
Hematologic Cancer
Thoracic Cancer
Keywords: Gastrointestinal Cancer
Hematologic Cancer
Thoracic Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2022-05-16
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Genomic testing uptake
timeFrame: Up to 90 days of enrollment
Secondary outcomes:
measure: Patient interaction with the intervention
timeFrame: Up to 30 days of enrollment
measure: Acceptability of questionnaire modality
timeFrame: Up to 30 days of enrollment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Brighton
country: United States
facility: Dana-Farber Cancer Institute at St. Elizabeth's Medical Center
state: Massachusetts
city: Methuen
country: United States
facility: Dana-Farber Cancer Instiute - Merrimack Valley
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Nadine J McCleary, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: