Increasing Germline Genetic Testing for Patients With Cancer

NCT07307664 | Recruiting

• 1 other identifier: gLHS
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 10

Brief Summary

Germline testing for hereditary cancer syndromes is underutilized across most health care settings. Using a learning health care approach, the Genomics-enabled Learning Health Systems (gLHS) network aims to evaluate the impact of a suite of implementation strategies to increase germline test ordering by oncology care teams (i.e., mainstreaming) for eligible patients with breast, pancreatic or colorectal cancer. Secondarily, the study will investigate completion of testing by eligible patients, as well as impact on overall rates of germline test ordering in patients with cancer. The network will bundle and deploy different implementation strategies across the clinical sites in three 6-month phases. A maintenance phase after the implementation periods will measure genetic testing rates without any additional implementation strategies to determine persistence of effects. The implementation strategies address clinician-level factors, and thus oncologists and their team members (e.g. advanced practice providers, nurse navigators, case managers) will be the focus of evaluating the impact of implementation strategies. Strategies that will be considered include provider education, audit and feedback reports, facilitation, peer support, and electronic health record (EHR) system optimization to support germline testing. Using the RE-AIM QuEST framework, outcomes will be assessed using mixed methods separately for each eligible cancer type. Data collection from the EHR, other relevant data sources, and qualitative provider feedback will be used to assess ordering and completion of tests and the effect of the implementation strategies on germline testing rates in oncology clinics.

Conditions

Hereditary Pancreatic Cancer; Conditions or Focus of Study; Hereditary Breast Cancer; Hereditary Colorectal Cancer

Keywords

Genomic Risk; Germline Testing; Hereditary Cancer; Learning Health Systems; Genomic Cancer Risk Assessment; Mainstreaming

Outcome Measures

Primary Outcomes (3)

• Germline Genetic Testing Ordered for Breast Cancer Patients

  Number of eligible breast cancer patients with germline genetic testing ordered by an oncology care team provider, or associated with an oncology visit, within 7 days of an oncology encounter divided by the number of eligible breast cancer patients seen by the oncology team

  48 months

• Germline Genetic Testing Ordered for Pancreatic Cancer Patients

  Number of eligible pancreatic cancer patients with germline genetic testing ordered by an oncology care team provider, or associated with an oncology visit, within 7 days of an oncology encounter divided by the number of eligible pancreatic cancer patients seen by the oncology care team.

  48 months

• Germline Genetic Testing Ordered for Colorectal Cancer Patients

  Number of eligible colorectal cancer patients with germline genetic testing ordered by an oncology care team provider, or associated with an oncology visit, within 7 days of an oncology encounter divided by the number of eligible colorectal cancer patients seen by the oncology care team.

  48 months

Secondary Outcomes (3)

• Germline Genetic Testing Completed by Breast Cancer Patients

  48 months

• Germline Genetic Testing Completed by Pancreatic Cancer Patients

  48 months

• Germline Genetic Testing Completed by Colorectal Cancer Patients

  48 months

Study Arms (1)

Oncology physicians and advanced practice providers

EXPERIMENTAL

Clinician members of oncology teams who care for adults with breast, pancreatic, or colorectal cancer will be the target population. We will assess changes in germline test orders for and completion by patients before and after deploying implementation strategies designed to promote testing uptake.

Behavioral: Implementation strategies

Interventions

Implementation strategies BEHAVIORAL

We will deploy different strategy bundles across the clinical sites in three approximate 6-month phases. Phase I - Facilitation of provider training, educational materials, and information resources; Patient-facing educational material and information resources Phase II - Audit and feedback report on existing patients; Practice champion support; Optimizing EHR strategies Phase III - EHR tools to facilitate prospective identification of patients, testing, and result reporting

Oncology physicians and advanced practice providers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Oncology care team members (including, but not limited to, oncologists, advanced practice providers, nurse navigators, caring for patients with adult patients with breast cancer, pancreatic cancer or colorectal cancer.

You may not qualify if:

• Providers not on the oncology care team

Sponsors & Collaborators

• Josh Peterson: lead
• National Human Genome Research Institute (NHGRI): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (10)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

NOT YET RECRUITING

Orlando VA Medical Center

Orlando, Florida, 32827, United States

NOT YET RECRUITING

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

NOT YET RECRUITING

Northwestern Medicine

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

NOT YET RECRUITING

Durham VA Medical Center

Durham, North Carolina, 27705, United States

NOT YET RECRUITING

Salisbury VA Health Care System

Salisbury, North Carolina, 28144, United States

RECRUITING

Geisinger

Danville, Pennsylvania, 17822, United States

NOT YET RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

RECRUITING

University of Utah Health

Salt Lake City, Utah, 84112, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Pancreatic carcinoma, familial; Breast Cancer, Familial

Study Officials

• Josh F Peterson, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan He, PhD

CONTACT

615-875-9641; megan.he@vumc.org

Lynn A Seabolt, MS, RD

CONTACT

615-875-7898; lynn.a.seabolt@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Biomedical Informatics and Medicine

Model Details: The clinical intervention the investigators will study is mainstreaming of germline testing by oncology care teams for adult patients with colorectal cancer diagnosed under age 50, female breast cancer diagnosed under age 66, and pancreatic cancer diagnosed at any age. These cancer diagnoses and age ranges follow evidence-based guidelines describing indications for germline testing for these patients (e.g., the National Comprehensive Cancer Network, American Society of Clinical Oncology-Society of Surgical Oncology).

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: December 29, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

US (10)