Improving genetic testing for cancer patients through nurse-led support
Genetic Testing Uptake Through an Enhanced Oncology Nurse-Led Intervention in Patients With Solid Tumors (GENESIS): A Pilot Study
This study is testing if support from oncology nurses can help adult cancer patients get better access to genetic testing and counseling to improve their treatment options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Chico, California and 1 other locations) |
| Trial ID | NCT06436157 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to enhance the uptake of genetic counseling and testing (GCT) among adult patients diagnosed with solid tumors by utilizing an oncology nurse-led intervention. The study addresses the significant barriers to GCT, particularly the low referral rates from oncologists, by providing enhanced education and support to patients. By identifying germline risks, the study seeks to improve patient outcomes through tailored cancer surveillance and treatment options. The intervention will be implemented at community cancer centers, focusing on patients eligible for GCT based on established guidelines.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with solid tumors who meet the NCCN guidelines for genetic testing and are starting or switching systemic therapy.
Not a fit: Patients who have previously undergone genetic testing since 2014 or those with cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly increase the number of cancer patients receiving appropriate genetic testing, leading to better personalized treatment and preventive strategies.
How similar studies have performed: Other studies have shown promising results in improving genetic testing uptake through nurse-led interventions, indicating that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chico, California and 1 other locations
- Enloe Regional Cancer Center — Chico, California, United States (Recruiting)
- University of California, Davis — Sacramento, California, United States (Active_not_recruiting)
Study contacts
- Principal investigator: Ranjan Pathak, MD MHS — Enloe Health
- Study coordinator: Rachel A Kitchen, CCRP
- Email: rkitchen@ucdavis.edu
- Phone: 406-417-1576
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.