NCT06436157 A Pilot Study of Genetic Testing Uptake Through Enhanced Oncology Nurse-Led Intervention
| NCT ID | NCT06436157 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Davis |
| Condition | Solid Tumor, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-12-26 |
| Primary Completion | 2025-03-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-12-26 with a primary completion date of 2025-03-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Contact & Investigator
Ranjan Pathak, MD MHS
PRINCIPAL INVESTIGATOR
Enloe Health
Frequently Asked Questions
Who can join the NCT06436157 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06436157 currently recruiting?
Yes, NCT06436157 is actively recruiting participants. Contact the research team at rkitchen@ucdavis.edu for enrollment information.
Where is the NCT06436157 trial being conducted?
This trial is being conducted at Chico, United States, Sacramento, United States.
Who is sponsoring the NCT06436157 clinical trial?
NCT06436157 is sponsored by University of California, Davis. The principal investigator is Ranjan Pathak, MD MHS at Enloe Health. The trial plans to enroll 60 participants.