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Broadening the Reach, Impact, and Delivery of Genetic Services (BRIDGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03985852
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
New York University
Information provided by (Responsible Party):
Kimberly Kaphingst, University of Utah

Brief Summary:
The purpose of this study is to compare the uptake of genetic testing among patients randomized with two different models of genetic services delivery (a patient-directed model and an enhanced standard of care model) and examine whether the impact on uptake differs by race/ethnicity and rurality. This study will also compare the effect of these delivery models on adherence to cancer prevention and screening recommendations and other patient responses.

Condition or disease Intervention/treatment Phase
Cancer Risk Reduction Behavior Other: Patient Directed Standard of Care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1980 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Broadening the Reach, Impact, and Delivery of Genetic Services
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing

Arm Intervention/treatment
Active Comparator: Patient Directed Standard of Care
Patients receive pre-test genetic counseling and, if relevant, post-test counseling for a negative result from an automated genetics education assistant.
Other: Patient Directed Standard of Care
The pre-test genetic counseling visit will be conducted through access to an automated genetics education assistant accessed through the patient portal. The automated approach will address all the components of the pre-test counseling and contains content designed by the genetic counselors at the University of Utah and NYU. Patients will have the option to contact genetic counselors through the patient portal, by phone, or in person but this will not be required. All results will be reviewed by a genetic counselor. Negative results will be returned by the automated genetics education assistant. Genetic counselors will return results for pathogenic variants and variants of uncertain significance via phone.

No Intervention: Enhanced Standard of Care
Patients receive standard counseling from a genetic counselor.



Primary Outcome Measures :
  1. Completion of genetic testing from electronic health record [ Time Frame: 1 month following pre-test genetic counseling ]
    Percentage of patients who decide to receive genetic testing


Secondary Outcome Measures :
  1. Completion of genetic counseling from electronic health record [ Time Frame: 1 month after study invitation ]
    Percentage of patients who decide to receive genetic counseling

  2. Adherence to management recommendations from genetic counselor: questionnaire [ Time Frame: 8 weeks and 13 months from pre-test counseling ]
    Adherence to cancer screening and prevention recommendations given by genetic counselor



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Speaks English

AND

  • First degree relative or second degree relative diagnosed with the following regardless of age: Ovarian Cancer, Pancreas Cancer

OR

  • First degree relative or second degree relative diagnosed with the following <50 years of age: Breast Cancer, Colorectal Cancer, Endometrial Cancer.

OR

  • Three of more relatives on the same side of the family diagnosed with the following clusters of cancer regardless of age:

    • Breast Cancer, Ovarian Cancer, Pancreas Cancer, Prostate Cancer
    • Colorectal Cancer, Endometrial Cancer, Ovarian Cancer, Pancreas Cancer, Urinary tract, Brain, Small intestine
    • Melanoma, Pancreas Cancer

OR

  • Ashkenazi Jewish ancestry and family history of Breast Cancer, Ovarian Cancer, Pancreas Cancer, Prostate Cancer.

Exclusion Criteria:

  • Patients with a prior cancer diagnosis, other than non-melanoma skin cancer, and/or prior genetic counseling or testing related to hereditary cancer.
  • Patients unable to access the patient portal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985852


Contacts
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Contact: Kimberly Kaphingst, PhD 801-213-5724 kim.kaphingst@hci.utah.edu
Contact: Kadyn Kimball, BS 8015859823 kadyn.kimball@hci.utah.edu

Sponsors and Collaborators
University of Utah
New York University

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Responsible Party: Kimberly Kaphingst, Professor, University of Utah
ClinicalTrials.gov Identifier: NCT03985852     History of Changes
Other Study ID Numbers: IRB_00115509
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No