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

Gastrointestinal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05375643
• Other study ID #: 21-709
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2023
• Est. completion date: July 30, 2025

Study information

• Verified date: May 2024
• Source: Dana-Farber Cancer Institute
• Contact: Nadine J McCleary, MD MPH
• Phone: (617) 632-6729
• Email: nj_mccleary[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: July 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Hematologic Cancer
• Hematologic Neoplasms
• Thoracic Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Dana-Farber Cancer Institute at St. Elizabeth's Medical Center	Brighton	Massachusetts
United States	Dana-Farber Cancer Instiute - Merrimack Valley	Methuen	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Nadine McCleary, MD, MPH	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genomic testing uptake	Intervention impact on rate of uptake of genomic testing	Up to 90 days of enrollment
Secondary	Patient interaction with the intervention	Interaction with each component of the intervention (as appropriate by intervention arm)	Up to 30 days of enrollment
Secondary	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