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

Part of paid clinical trials in Chico, California.

Sponsor
University of California, Davis
Study ID
NCT06436157
Status
Recruiting
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Conditions

  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enhanced education — OTHER
    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 — OTHER
    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.

Study Details

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 Dates

Start date
Dec 26, 2024
Status verified
Jan 2025
Primary completion
Mar 26, 2025
Completion
Sep 26, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

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

Locations (2)

FacilityCityStateZIPSite coordinators
Enloe Regional Cancer CenterChicoCalifornia95926
Grant Harris, BS
[email protected]
530-332-3858
Ranjan Pathak, MD (PRINCIPAL_INVESTIGATOR)
University of California, DavisSacramentoCalifornia95616-

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By research site
Enloe Regional Cancer Center· Chico, CAUniversity of California, Davis· Sacramento, CA

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