SURGE: Supporting Utility and Representation in Genomics-based Cancer Trial Enrollment (Intervention)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNadine Jackson, MD, MPH
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
SURGE
BehavioralVideo with or without person to person guidance to support decision making around genetic testing
Treatment groups
210 Participants
are divided into 3 treatment groupsGroup A: Arm B (informational video)Experimental treatment 1 intervention
Group B: Arm A (standard of care)No intervention 0 interventions
Group C: Arm C (informational video and patient navigation)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Genomic testing uptake
Intervention impact on rate of uptake of genomic testing
Time frame
Up to 90 days of enrollmentSecondary outcomes
1
Patient interaction with the intervention
Interaction with each component of the intervention (as appropriate by intervention arm)
Time frame
Up to 30 days of enrollment2
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.
Time frame
Up to 30 days of enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nadine Jackson, MD, MPH
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov