SURGE: Supporting UnderRepresented Minorities in Genomics-based Cancer Trial Enrollment (Intervention)
Study Details
Study Description
Brief Summary
The SURGE(Supporting UnderRepresented minorities in Genomics-based cancer trial Enrollment) intervention is a patient navigation intervention that will support patients in their decision to consent to PROFILE OncoPanel (DFCI protocol 17-000). Consent to PROFILE allows patients to receive genomic testing as part of cancer clinical trial eligibility.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a randomized pilot study to assess the feasibility of the SURGE (Supporting UnderRepresented minorities in Genomics-based cancer trial Enrollment) intervention, with the intention of scaling SURGE using the preliminary data gathered during this pilot.
Participants will be randomly assigned to receive standard of care or the SURGE intervention. SURGE is comprised of a patient navigator, text message questionnaire, and informational video to help support underrepresented minority patients on making decisions about enrolling in cancer clinical trials and consenting to genomic testing.
The trial is expected to have 100 participants.
Bristol Myers Squibb and a private donor are providing funding for the trial.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SURGE Participants will complete screening questionaire via text or by phone to establish baseline awareness and interest in clinical trials and then randomized to the SURGE program and receive: Informational Video followed by a questionnaire Patient Navigator providing one on one guidance Genomic Testing offer with patient navigator decision support |
Behavioral: SURGE
Video and person to person guidance to support decision making on clinical trial and/or genetic testing participation.
|
| Experimental: Standard of Care (SOC) Participants will complete screening questionaire via text or by phone to establish baseline awareness and interest in clinical trials and then randomized to Standard of Care (SOC) and receive: Genomic Testing offer as part of their oncology provider consult |
Behavioral: Standard of Care
Clinical trials and/or genetic testing information provided of as part of routine patient care
|
Outcome Measures
Primary Outcome Measures
- Consent rates to PROFILE [From the end of accrual, up to 3 years following study initiation]
Primary outcome is feasibility. Feasibility will be defined as a 30% increase in consent rates to PROFILE genomic testing (DFCI protocol 17-000) compared to the control group receiving standard care without the patient navigator or informational video.
- PROFILE genomic testing completion rates [From the end of accrual, up to 3 years following study initiation]
PROFILE genomic testing (DFCI protocol 17-000) completion rates, for each enrollment group, will be defined as the proportion of patients completing PROFILE out of those enrolled in the study.
Secondary Outcome Measures
- Questionnaire response rate [From the end of accrual, up to 3 years following study initiation]
Questionnaire response rates, for each enrollment group, will be defined as the proportion of patients responding to the screening questionnaire out of those enrolled in the study.
- Clinical trial awareness/readiness and PROFILE genomic testing correlates [From the end of accrual, up to 3 years following study initiation]
Patient demographic and disease characteristics correlated with awareness/readiness for clinical trials will be determined using multivariate regression. Patient demographic and disease characteristics correlated with PROFILE genomic testing (DFCI protocol 17-000) consent will be determined using multivariate regression."
- Initial readiness and awareness of clinical trials [From the end of accrual, up to 3 years following study initiation]
Patient readiness for clinical trial enrollment, for each enrollment group, will be defined as the proportion of patients reporting readiness on the initial screening questionnaire out of those enrolled in the study. Patient awareness of clinical trials, for each enrollment group, will be defined as the proportion of patients reporting awareness on the initial screening questionnaire out of those enrolled in the study.
- Change in readiness and awareness of clinical trials [From the end of accrual, up to 3 years following study initiation]
Change in patient readiness for clinical trial enrollment, for each enrollment group, will be defined as the proportion of patients reporting reporting a change readiness on their follow up screening questionnaire out of those enrolled in the study. Change in patient awareness of clinical trials, for each enrollment group, will be defined as the proportion of patients reporting reporting a change awareness on their follow up screening questionnaire out of those enrolled in the study."
- No consent to PROFILE genomic testing after video [From the end of accrual, up to 3 years following study initiation]
Proportion of patients, for each enrollment group, documenting non-readiness and also not consenting to sequencing, who complete the informational video.
- Consent to PROFILE genomic testing but insufficient tissues for sequencing [From the end of accrual, up to 3 years following study initiation]
Proportion of patients, for each enrollment group, who consent to PROFILE genomic testing but have insufficient tissues to complete sequencing.
- Consent to PROFILE genomic testing but no archival tissue for sequencing [From the end of accrual, up to 3 years following study initiation]
Proportion of patients, for each enrollment group, who consent to PROFILE genomic testing but have no archival tissue to complete sequencing.
- Consent to PROFILE genomic testing and precision clinical trial enrollment [From the end of accrual, up to 3 years following study initiation]
Proportion of patients, for each enrollment group, who consent to PROFILE genomic testing and enroll in a precision clinical trial.
- Consent to PROFILE genomic testing with GI TARGET review and precision clinical trial enrollment [From the end of accrual, up to 3 years following study initiation]
Proportion of patients, for each enrollment group, who consent to PROFILE genomic testing with GI TARGET review and enroll in a precision clinical trial.
- Consent to Rapid Heme Panel and precision clinical trial enrollment [From the end of accrual, up to 3 years following study initiation]
Proportion of leukemia patients, for each enrollment group, completing the Rapid Heme Panel who enroll in a precision clinical trial.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 or older
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Advanced cancer:
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Metastatic disease OR
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Stage IV
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Cancer type
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Gastrointestinal
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Hematologic
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Thoracic
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Scheduled for a new patient consultation
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DFCI patient:
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Longwood/Chestnut Hill
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DFCI satellite at St. Elizabeth's Medical Center
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DFCI satellite at Merrimack Valley
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Historically underrepresented:
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Black, Latinx, American Indian, or Pacific Islander
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LEP Spanish (As indicated by the EHR)
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Older adult (Age 70+)
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Low SES
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From zip code with median household income <$32,000/year OR
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Social determinants of health (SDoH) need
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Any one response on the DFCI New Patient Intake Questionnaire (NPIQ) indicating an SDoH need
Exclusion Criteria:
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Not continuing care at DFCI Longwood/Chestnut Hill, DFCI St. Elizabeth's Medical Center or DFCI Merrimack Valley
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Speaks a language other than English or Spanish
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Unable to provide consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 2 | Dana-Farber Cancer Institute at St. Elizabeth's Medical Center | Brighton | Massachusetts | United States | 02135 |
| 3 | Dana-Farber Cancer Instiute - Merrimack Valley | Methuen | Massachusetts | United States | 01844 |
Sponsors and Collaborators
- Nadine McCleary MD, MPH
- Bristol-Myers Squibb
Investigators
- Principal Investigator: Nadine J McCleary, MD MPH, Dana-Farber Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-709