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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gastrointestinal Cancer, Hematologic Cancer, Thoracic Cancer

Intervention / Treatment
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* Behavioral: SURGE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm B (informational video)<br>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<br>* Video with or without person to person guidance to support decision making around genetic testing<br>|
| No Intervention: Arm A (standard of care)<br>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)<br>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<br>* Video with or without person to person guidance to support decision making around genetic testing<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal Cancer, Hematologic Cancer, Thoracic Cancer