← Back to searchRecruitingRecruiting
Increasing Germline Genetic Testing for Patients With Cancer
NCT07307664 · Vanderbilt University Medical Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
This project seeks to close the acknowledged care gap in genetic testing of hereditary cancer predisposition by evaluating implementation strategies expected to increase guideline-concordant germline genetic testing (referred to in protocol as "germline testing" and defined as testing for inherited gene variants related to cancer) by oncology care teams (i.e., 'mainstreaming', or 'task-shifting' from the traditional genetic consultation referral model). Identification of inherited pathogenic variants in individuals with a cancer diagnosis can have implications for treatment, with targeted therapies. Furthermore, identifying individuals with hereditary risk provides an opportunity for surveillance for early detection of other cancers or risk-reducing procedures. Finally, identifying a pathogenic variant allows for cascade testing in family members, extending these benefits to more individuals. Germline testing for hereditary cancer within current clinical practice is underutilized across most health care settings, even though evidence supports effectiveness to inform clinical care. Mainstreaming is service delivery model that has emerged to improve access to germline testing. It shifts the clinical activities of pre- and post- test germline testing to frontline clinician teams. Here, the investigators will be studying the implementation of mainstreaming throughout the germline testing process, from recognizing patients who are eligible for germline testing to disclosing results for those who opt to test.
The study will assess changes in germline test orders for and completion by patients with cancer who receive care across the clinical sites in the gLHS Network before and after deploying implementation strategies designed to promote testing uptake. There will be three implementation phases followed by a maintenance period. The selected implementation strategies are widely used to improve clinical practice and address barriers previously reported in the literature and documented in participating sites. These strategies will aim to increase mainstreaming of germline testing by oncology teams. Most studies evaluating mainstreaming of germline testing for cancer have been performed in relatively small numbers of patients often at single institutions focusing on outcomes of feasibility and patient and provider satisfaction. Implementation outcomes (e.g., reach, adoption, implementation) precede and impact both service and patient outcomes. Thus, understanding implementation outcomes for mainstreaming of germline testing, as well as contextual factors that are associated with successful implementation, is fundamental to achieving high-quality genetic health care.
Eligibility criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Providers not on the oncology care team
Study design
Enrollment target: 1000 participants
Allocation: na
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2026-01-30
Estimated completion: 2030-01-01
Last updated: 2026-04-03
Interventions
Behavioral: Implementation strategies
Primary outcomes
- • Germline Genetic Testing Ordered for Breast Cancer Patients (48 months)
- • Germline Genetic Testing Ordered for Pancreatic Cancer Patients (48 months)
- • Germline Genetic Testing Ordered for Colorectal Cancer Patients (48 months)
Sponsor
Josh Peterson · other
With: National Human Genome Research Institute (NHGRI), National Cancer Institute (NCI)
Contacts & investigators
ContactMegan He, PhD · contact · megan.he@vumc.org · 615-875-9641
ContactLynn A Seabolt, MS, RD · contact · lynn.a.seabolt@vumc.org · 615-875-7898
InvestigatorJosh F Peterson, MD, MPH · principal_investigator, Vanderbilt University Medical Center
All locations (10)
VA Greater Los Angeles Healthcare SystemRecruiting
Los Angeles, California, United States
Orlando VA Medical CenterRecruiting
Orlando, Florida, United States
Atlanta VA Medical CenterRecruiting
Decatur, Georgia, United States
Northwestern MedicineNot Yet Recruiting
Chicago, Illinois, United States
Indiana University School of MedicineRecruiting
Indianapolis, Indiana, United States
Durham VA Medical CenterRecruiting
Durham, North Carolina, United States
Salisbury VA Health Care SystemRecruiting
Salisbury, North Carolina, United States
GeisingerRecruiting
Danville, Pennsylvania, United States
Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States
University of Utah HealthNot Yet Recruiting
Salt Lake City, Utah, United States