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Recruiting NCT05375643

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

No phase Interventional Gastrointestinal Cancer Hematologic Cancer Thoracic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SURGE.
Who it may be relevant to
Registry conditions: Gastrointestinal Cancer, Hematologic Cancer, Thoracic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral SURGE
    Video with or without person to person guidance to support decision making around genetic testing

Primary outcome measures

  • Genomic testing uptake [Time frame: Up to 90 days of enrollment]
Secondary outcome measures (2)
  • Patient interaction with the intervention [Time frame: Up to 30 days of enrollment]
  • Acceptability of questionnaire modality [Time frame: Up to 30 days of enrollment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 3 centers
  • Dana Farber Cancer Institute — Boston
  • Dana-Farber Cancer Institute at St. Elizabeth's Medical Center — Brighton
  • Dana-Farber Cancer Instiute - Merrimack Valley — Methuen

Identifiers

NCT: NCT05375643 · 21-709

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗