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

Primary Purpose

Gastrointestinal Cancer, Hematologic Cancer, Thoracic Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

SURGE

About this trial

This is an interventional health services research trial for Gastrointestinal Cancer focused on measuring Gastrointestinal Cancer, Hematologic Cancer, Thoracic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 or older
Advanced cancer:
- Metastatic disease OR
- Stage IV
Cancer type
- Gastrointestinal
- Hematologic
- Thoracic
Scheduled for a new patient consultation
DFCI patient:
- Longwood/Chestnut Hill
- DFCI satellite at St. Elizabeth's Medical Center
- DFCI satellite at Merrimack Valley
Historically underrepresented:
- Black, Latinx, American Indian, or Pacific Islander
- LEP Spanish (As indicated by the EHR)
- Older adult (Age 70+)
- Low SES
- From zip code with median household income <$32,000/year OR
- Social determinants of health (SDoH) need
  - Any one response on the DFCI New Patient Intake Questionnaire (NPIQ) indicating an SDoH need

Exclusion Criteria:

Not continuing care at DFCI Longwood/Chestnut Hill, DFCI St. Elizabeth's Medical Center or DFCI Merrimack Valley
Speaks a language other than English or Spanish
Unable to provide consent

Sites / Locations

Dana Farber Cancer InstituteRecruiting
Dana-Farber Cancer Institute at St. Elizabeth's Medical CenterRecruiting
Dana-Farber Cancer Instiute - Merrimack Valley

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Arm B (informational video)

Arm A (standard of care)

Arm C (informational video and patient navigation)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Genomic testing uptake

Intervention impact on rate of uptake of genomic testing

Secondary Outcome Measures

Patient interaction with the intervention

Interaction with each component of the intervention (as appropriate by intervention arm)

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.

Full Information

NCT ID

NCT05375643

First Posted

May 11, 2022

Last Updated

April 17, 2023

Sponsor

Nadine McCleary, MD, MPH

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT05375643

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 3, 2023 (Actual)

Primary Completion Date

December 30, 2024 (Anticipated)

Study Completion Date

July 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nadine McCleary, MD, MPH

Collaborators

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastrointestinal Cancer, Hematologic Cancer, Thoracic Cancer

Keywords

Gastrointestinal Cancer, Hematologic Cancer, Thoracic Cancer

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm B (informational video)

Arm Type

Experimental

Arm Description

Arm Title

Arm A (standard of care)

Arm Type

No Intervention

Arm Description

Arm Title

Arm C (informational video and patient navigation)

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

SURGE

Intervention Description

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

Primary Outcome Measure Information:

Title

Genomic testing uptake

Description

Intervention impact on rate of uptake of genomic testing

Time Frame

Up to 90 days of enrollment

Secondary Outcome Measure Information:

Title

Patient interaction with the intervention

Description

Interaction with each component of the intervention (as appropriate by intervention arm)

Time Frame

Up to 30 days of enrollment

Title

Acceptability of questionnaire modality

Description

Time Frame

Up to 30 days of enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nadine J McCleary, MD MPH

Phone

(617) 632-6729

nj_mccleary@dfci.harvard.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Nadine J McCleary, MD MPH

Phone

(617) 632-6729

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nadine J McCleary, MD MPH

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nadine J. McCleary, MD, MPH

Phone

617-632-6729

nj_mccleary@dfci.harvard.edu

First Name & Middle Initial & Last Name & Degree

Nadine J. McCleary, MD, MPH

Facility Name

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

City

Brighton

State/Province

Massachusetts

ZIP/Postal Code

02135

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olga Kozyreva, MD

olga_kozyreva@dfci.harvard.edu

First Name & Middle Initial & Last Name & Degree

Olga Kozyreva, MD

Facility Name

Dana-Farber Cancer Instiute - Merrimack Valley

City

Methuen

State/Province

Massachusetts

ZIP/Postal Code

01844

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pedro Sanz-Altamira, MD

pedro_sanz-altamira@dfci.harvard.edu

First Name & Middle Initial & Last Name & Degree

Pedro Sanz-Altamira, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

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

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