A Pilot Study of Genetic Testing Uptake Through Enhanced Oncology Nurse-Led Intervention

Recruiting now · Not applicable

Conditions studied: Solid Tumor, Adult

In brief

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.

Key facts

Study ID

NCT06436157

Run by

University of California, Davis

People needed

60

Starts

2024-12-26

Expected to finish

2025-09-26

Last updated by the study team

2025-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults (≥ 18 years)
• Diagnosed with a solid tumor cancer type that has established guidelines suggesting the utility of genetic testing in treatment (breast, ovarian, prostate, pancreatic, colon, Lynch syndrome-related cancers (colorectal, endometrial, gastric, ovarian, pancreatic, urothelial, brain (usually glioblastoma), biliary tract, small intestine), Li-Fraumeni syndrome tumor spectrum (e.g., soft tissue sarcoma, osteosarcoma, central nervous system tumors, breast cancer, adrenocortical carcinoma), etc.)
• Eligible for GCT based on the current NCCN guidelines
• Starting new systemic therapy or switching systemic therapy
• Eligible for GCT as per the current NCCN guidelines
• No prior genetic testing (or tested before 2014)

You may not qualify if…

• Prior GCT with test results available (if tested 2014 onwards)
• Patients scheduled for treatment education with Advanced Practice Provider (typically reserved for more complex regimens)
• Patients with cognitive impairments or severe psychological disorders that would limit their ability to understand the genetic counseling/testing information or give informed consent.
• Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures (e.g., patients requiring urgent therapy and/or inpatient chemotherapy initiation).
• Patients who are currently participating in other clinical trials that could confound the outcomes of genetic testing uptake.
• Prospective participants who, in the investigator's opinion, may not be able to comply with all study procedures (including compliance issues related to logistics).
• Hematologic malignancy

Where it is running

• Enloe Regional Cancer Center — Chico, California, United States (enrolling)
• University of California, Davis — Sacramento, California, United States

Full record on ClinicalTrials.gov

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