Increasing Germline Genetic Testing for Patients With Cancer

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

Interventions

BEHAVIORAL

Implementation strategies

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

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI)

  collaborator NIH

• National Cancer Institute (NCI)

  collaborator NIH

• Josh Peterson

  lead OTHER

Principal Investigators

• Josh F Peterson, MD, MPH · Vanderbilt University Medical Center

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-01-30

Primary Completion

2030-01-01

Completion

2030-01-01

Countries

• United States

Study Locations