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

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Cancer; Gastrointestinal Cancer; Hematologic Cancer
• Intervention / Treatment: Behavioral: SURGE

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.

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nadine J McCleary, MD MPH; Phone Number: (617) 632-6729; Email: nj_mccleary@dfci.harvard.edu
• Study Contact Backup: Name: Nadine J McCleary, MD MPH; Phone Number: (617) 632-6729

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana Farber Cancer Institute
      • Principal Investigator: Nadine J. McCleary, MD, MPH
      • Contact: Nadine J. McCleary, MD, MPH; Phone Number: (617) 632-6729; Email: nj_mccleary@dfci.harvard.edu
    • Brighton, Massachusetts, United States, 02135
      • Recruiting
      • Dana-Farber Cancer Institute at St. Elizabeth's Medical Center
      • Contact: Olga Kozyreva, MD; Email: olga_kozyreva@dfci.harvard.edu
      • Principal Investigator: Olga Kozyreva, MD
    • Methuen, Massachusetts, United States, 01844
      • Not yet recruiting
      • Dana-Farber Cancer Instiute - Merrimack Valley
      • Contact: Pedro Sanz-Altamira, MD; Email: pedro_sanz-altamira@dfci.harvard.edu
      • Principal Investigator: Pedro Sanz-Altamira, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm B (informational video); 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	Behavioral: SURGE; Video with or without person to person guidance to support decision making around genetic testing
No Intervention: Arm A (standard of care); Participants will complete screening questionnaire via text or by phone to establish baseline awareness and interest in clinical trials and then randomized to Standard of Care (SOC) and receive: Standard of Care
Experimental: Arm C (informational video and patient navigation); 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	Behavioral: SURGE; Video with or without person to person guidance to support decision making around genetic testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genomic testing uptake	Intervention impact on rate of uptake of genomic testing	Up to 90 days of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient interaction with the intervention	Interaction with each component of the intervention (as appropriate by intervention arm)	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.	Up to 30 days of enrollment

Collaborators and Investigators

• Sponsor: Nadine McCleary, MD, MPH
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Nadine J McCleary, MD MPH, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): July 30, 2028

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Estimated): November 5, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Gastrointestinal Cancer; Thoracic Cancer; Hematologic Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Gastrointestinal Neoplasms
• Other Study ID Numbers: 21-709

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No