Increasing Germline Genetic Testing for Patients With Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorJosh Peterson

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Providers not on the oncology care team

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Oncology physicians and advanced practice providersExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
48 months
2

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.

Time frame
48 months
3

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.

Time frame
48 months

Secondary outcomes

1

Germline Genetic Testing Completed by Breast Cancer Patients

Number of eligible breast cancer patients completing germline testing order that was placed by their oncology care team divided by the number of eligible breast cancer patients with an order placed by the oncology care team determined by EHR data extraction.

Time frame
48 months
2

Germline Genetic Testing Completed by Pancreatic Cancer Patients

Number of eligible pancreatic cancer patients completing germline testing order that was placed by their oncology care team divided by the number of eligible pancreatic cancer patients with an order placed by the oncology care team determined by EHR data extraction.

Time frame
48 months
3

Germline Genetic Testing Completed by Colorectal Cancer Patients

Number of eligible colorectal cancer patients completing germline testing order that was placed by their oncology care team divided by the number of eligible colorectal cancer patients with an order placed by the oncology care team determined by EHR data extraction.

Time frame
48 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Josh Peterson

Lead sponsor

Vanderbilt University Medical Center

Sponsor institution

National Human Genome Research Institute (NHGRI)

Collaborator

National Cancer Institute (NCI)

Collaborator