Broadening the Reach, Impact, and Delivery of Genetic Services

NCT03985852 | Completed Results

• 1 other identifier: IRB_00115509
• Study Type: interventional
• Target: 3,073
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer; Risk Reduction Behavior

Outcome Measures

Primary Outcomes (1)

• Completion of Genetic Testing From Electronic Health Record

  Percentage of patients who decide to receive genetic testing

  1 month following pre-test genetic counseling

Secondary Outcomes (2)

• Completion of Pre-test Genetic Counseling From Electronic Health Record

  1 month after study invitation

• Adherence to Colonoscopy: Questionnaire

  8 weeks and 13 months from pre-test counseling

Study Arms (2)

Patient Directed Standard of Care

ACTIVE COMPARATOR

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

Enhanced Standard of Care

NO INTERVENTION

Patients receive standard counseling from a genetic counselor.

Interventions

Patient Directed Standard of Care OTHER

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.

Patient Directed Standard of Care

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Speaks English or Spanish
• AND
• First degree relative or second degree relative diagnosed with the following regardless of age: Ovarian Cancer, Pancreas Cancer
• First degree relative or second degree relative diagnosed with the following \<50 years of age: Breast Cancer, Colorectal Cancer, Endometrial Cancer.
• 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
• Ashkenazi Jewish ancestry and family history of Breast Cancer, Ovarian Cancer, Pancreas Cancer, Prostate Cancer.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• New York University: collaborator

Study Sites (2)

NYU School of Medicine

New York, New York, 10016, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (3)

• Bather JR, Goodman MS, Harris A, Del Fiol G, Hess R, Wetter DW, Chavez-Yenter D, Zhong L, Kaiser-Jackson L, Chambers R, Bradshaw R, Kohlmann W, Colonna S, Espinel W, Monahan R, Buys SS, Ginsburg O, Kawamoto K, Kaphingst KA; BRIDGE research team. Social vulnerability and genetic service utilization among unaffected BRIDGE trial patients with inherited cancer susceptibility. BMC Cancer. 2025 Jan 31;25(1):180. doi: 10.1186/s12885-025-13495-4.

  PMID: 39891096 DERIVED

• Kaphingst KA, Kohlmann WK, Lorenz Chambers R, Bather JR, Goodman MS, Bradshaw RL, Chavez-Yenter D, Colonna SV, Espinel WF, Everett JN, Flynn M, Gammon A, Harris A, Hess R, Kaiser-Jackson L, Lee S, Monahan R, Schiffman JD, Volkmar M, Wetter DW, Zhong L, Mann DM, Ginsburg O, Sigireddi M, Kawamoto K, Del Fiol G, Buys SS. Uptake of Cancer Genetic Services for Chatbot vs Standard-of-Care Delivery Models: The BRIDGE Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2432143. doi: 10.1001/jamanetworkopen.2024.32143.

  PMID: 39250153 DERIVED

• Kaphingst KA, Kohlmann W, Chambers RL, Goodman MS, Bradshaw R, Chan PA, Chavez-Yenter D, Colonna SV, Espinel WF, Everett JN, Gammon A, Goldberg ER, Gonzalez J, Hagerty KJ, Hess R, Kehoe K, Kessler C, Kimball KE, Loomis S, Martinez TR, Monahan R, Schiffman JD, Temares D, Tobik K, Wetter DW, Mann DM, Kawamoto K, Del Fiol G, Buys SS, Ginsburg O; BRIDGE research team. Comparing models of delivery for cancer genetics services among patients receiving primary care who meet criteria for genetic evaluation in two healthcare systems: BRIDGE randomized controlled trial. BMC Health Serv Res. 2021 Jun 2;21(1):542. doi: 10.1186/s12913-021-06489-y.

  PMID: 34078380 DERIVED

MeSH Terms

Conditions

Neoplasms; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Kimberly Kaphingst
• Organization: University of Utah

kim.kaphingst@hci.utah.edu

801-213-5724

Study Officials

• Kimberly Kaphingst, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 14, 2019
• Study Start: February 19, 2020
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2024
• Last Updated: September 22, 2025
• Results First Posted: January 8, 2025

Record last verified: 2025-08

Locations

US (2)