Actively Recruiting
A Pilot Study of Genetic Testing Uptake Through Enhanced Oncology Nurse-Led Intervention
Led by University of California, Davis · Updated on 2025-01-31
60
Participants Needed
2
Research Sites
39 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
E
Enloe Regional Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Genetic factors are a significant determinant of the likelihood of developing various types of cancers. Identification of germline risk can have important implications for both patients and their families. Although estimates vary, pathogenic germline variants can be seen in \~3-17.5% of unselected patients with cancer with important clinical significance. Unfortunately, despite progress in multigene testing and the identification of heritable conditions, genetic counseling and testing (GCT) remains underutilized among cancer patients. Although there are multiple barriers to low testing, initial referral to GCT from the treating oncologist has been noted to be the most significant barrier. Nurse navigation has been shown to improve the timeliness of cancer care and patient outcomes across various cancer types and improve the uptake of genomic testing in cancer patients. Despite proven benefits, community cancer centers often face resource limitations that prevent them from consistently assigning a dedicated nurse navigator to cancer patients. However, community centers universally have oncology nurses who routinely educate patients about their systemic therapies. By enhancing the "therapy education" sessions, the investigators hypothesize that oncology nurses can bridge this gap and potentially identify eligible patients, provide essential education on the importance of genetic testing, and facilitate the referral process. The investigators propose a pilot randomized study to evaluate the potential effectiveness, acceptability, and feasibility of a novel, nurse-led "enhanced education" intervention specifically designed to increase the uptake of GCT in adult cancer patients.
CONDITIONS
Official Title
A Pilot Study of Genetic Testing Uptake Through Enhanced Oncology Nurse-Led Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (18 years or older)
- Diagnosed with a solid tumor cancer type with established guidelines supporting genetic testing (breast, ovarian, prostate, pancreatic, colon, Lynch syndrome-related cancers, Li-Fraumeni syndrome tumor spectrum, etc.)
- Eligible for genetic counseling and testing based on current NCCN guidelines
- Starting new systemic therapy or switching systemic therapy
- No prior genetic testing or tested before 2014
You will not qualify if you...
- Prior genetic counseling and testing with available results if tested in 2014 or later
- Scheduled for treatment education with an Advanced Practice Provider
- Cognitive impairments or severe psychological disorders limiting understanding or consent
- Any condition contraindicating study participation due to safety concerns
- Currently participating in other clinical trials that may affect genetic testing outcomes
- Inability to comply with study procedures
- Diagnosis of hematologic malignancy
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Enloe Regional Cancer Center
Chico, California, United States, 95926
Actively Recruiting
2
University of California, Davis
Sacramento, California, United States, 95616
Active, Not Recruiting
Research Team
R
Rachel A Kitchen, CCRP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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