Recruiting

Observational Study

Sponsor:

Nadine McCleary, MD, MPH

Code:

NCT05375643

Conditions

Gastrointestinal Cancer

Hematologic Cancer

Thoracic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SURGE

Study Details

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.

Conditions

Gastrointestinal Cancer

Hematologic Cancer

Thoracic Cancer

Study ID

NCT05375643

Start date

Apr 3, 2023

Status verified date

Sep, 2025

Completion date

Jul 30, 2028

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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

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

Interventions

SURGE

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

Primary outcome measure

  • Genomic testing uptake [ Time Frame: Up to 90 days of enrollment ]

Central Contacts and Locations

Central contacts

Nadine J McCleary, MD MPH

(617) 632-6729nj_mccleary@dfci.harvard.edu

Nadine J McCleary, MD MPH

(617) 632-6729

Locations

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Nadine J. McCleary, MD, MPH

(617) 632-6729nj_mccleary@dfci.harvard.edu

Principal Investigator:

Nadine J. McCleary, MD, MPH

Dana-Farber Cancer Institute at St. Elizabeth's Medical Center

Recruiting

Brighton, Massachusetts, United States, 02135

Contacts

Olga Kozyreva, MD

olga_kozyreva@dfci.harvard.edu

Principal Investigator:

Olga Kozyreva, MD

More Information

Sponsor

Nadine McCleary, MD, MPH

Last update posted

Nov 5, 2025

Last verified

Sep, 2025

Keywords

  • Gastrointestinal Cancer
  • Hematologic Cancer
  • Thoracic Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Nadine McCleary, MD, MPH on 2025-11-05.