Recruiting

Genetic Testing

Sponsor:

UCLA

Code:

NCT06436157

Conditions

Solid Tumor, Adult

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Enhanced education

Usual care education

Study Details

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.

Conditions

Solid Tumor, Adult

Study ID

NCT06436157

Start date

Dec 26, 2024

Status verified date

Jan, 2025

Completion date

Sep 26, 2025

Anticipated

Primary completion date

Mar 26, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Enhanced Education Intervention

Patients in the enhanced education intervention arm will be scheduled for a redesigned therapy education session with a trained oncology nurse.

active comparator: Usual Care Education Arm

Patients in this arm will receive the usual care education provided to cancer patients undergoing systemic therapy, which includes information on treatment options, side effects, and support services without targeted genetic testing education.

Interventions

Enhanced education

In addition to the education conducted as part of usual care, the nurse will: 1) provide basic education on GCT; and 2) if the patient is eligible and agreeable to GCT, place a referral to GCT (if not already ordered).

Patients will also be provided with written materials reinforcing the key messages of GCT education, designed to be understandable to individuals without a medical background. Nurses will also conduct a follow-up "nudge" by sending an in basket message via electronic medical record to ensure that the referrals are processed by the referral coordinators.

Usual care education

A brief introduction to GCT will be provided in accordance with the information covered in the "chemo education binder," which is the current standard of care at Enloe Regional Cancer Center. As per the usual care, referrals for genetic testing will be clinician-initiated without the proactive involvement of the RN.

Primary outcome measure

  • Percentage of patients in each arm who proceed to GCT consultation following the intervention. [ Time Frame: Through study completion, an average of 9 months ]

Central Contacts and Locations

Central contacts

Rachel A Kitchen, CCRP

406-417-1576rkitchen@ucdavis.edu

Locations

Enloe Regional Cancer Center

Recruiting

Chico, California, United States, 95926

Contacts

Grant Harris, BS

530-332-3858grant.harris@enloe.org

Principal Investigator:

Ranjan Pathak, MD

More Information

Sponsor

University of California, Davis

Last update posted

Jan 31, 2025

Last verified

Jan, 2025

Keywords

  • Genetic Counseling and Testing
  • NCCN guidelines
  • Utilization
  • Feasibility
  • Nurse-led care coordination

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-04. This information was provided to ClinicalTrials.gov by University of California, Davis on 2025-01-31. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.