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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm B (informational video) | Experimental | 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:
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| Arm A (standard of care) | No Intervention | 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:
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| Arm C (informational video and patient navigation) | Experimental | 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SURGE | Behavioral | Video with or without person to person guidance to support decision making around genetic testing |
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| Measure | Description | Time Frame |
|---|---|---|
| Genomic testing uptake | Intervention impact on rate of uptake of genomic testing | Up to 90 days of enrollment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadine J McCleary, MD MPH | Contact | (617) 632-6729 | nj_mccleary@dfci.harvard.edu | |
| Nadine J McCleary, MD MPH | Contact | (617) 632-6729 |
| Name | Affiliation | Role |
|---|---|---|
| Nadine J McCleary, MD MPH | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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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 |
| Dana-Farber Cancer Institute at St. Elizabeth's Medical Center | Recruiting | Brighton | Massachusetts | 02135 | United States |
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| Dana-Farber Cancer Instiute - Merrimack Valley | Not yet recruiting | Methuen | Massachusetts | 01844 | United States |
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| D005767 |
| Gastrointestinal Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |