SURGE: Supporting UnderRepresented Minorities in Genomics-based Cancer Trial Enrollment (Intervention)
1 other identifier
interventional
210
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2022
CompletedFirst Posted
Study publicly available on registry
May 16, 2022
CompletedStudy Start
First participant enrolled
April 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2028
November 5, 2025
September 1, 2025
4.7 years
May 11, 2022
November 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Genomic testing uptake
Intervention impact on rate of uptake of genomic testing
Up to 90 days of enrollment
Secondary Outcomes (2)
Patient interaction with the intervention
Up to 30 days of enrollment
Acceptability of questionnaire modality
Up to 30 days of enrollment
Study Arms (3)
Arm B (informational video)
EXPERIMENTALParticipants 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
Arm A (standard of care)
NO INTERVENTIONParticipants 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
Arm C (informational video and patient navigation)
EXPERIMENTALParticipants 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
Interventions
Video with or without person to person guidance to support decision making around genetic testing
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nadine McCleary, MD, MPHlead
- Bristol-Myers Squibbcollaborator
Study Sites (3)
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute at St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135, United States
Dana-Farber Cancer Instiute - Merrimack Valley
Methuen, Massachusetts, 01844, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nadine J McCleary, MD MPH
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor-Investigator
Study Record Dates
First Submitted
May 11, 2022
First Posted
May 16, 2022
Study Start
April 3, 2023
Primary Completion (Estimated)
December 30, 2027
Study Completion (Estimated)
July 30, 2028
Last Updated
November 5, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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.