Barriers to the utilization of genetic testing and genetic counseling in patients with suspected hereditary breast and ovarian cancers.
Alicia Swink, Anju Nair, Pamela Hoof...
https://pubmed.ncbi.nlm.nih.gov/31384183/Actively Recruiting
Led by University of California, Davis · Updated on 2025-01-31
60
Participants Needed
2
Research Sites
26 weeks
Total Duration
Genetic factors play a key role in the risk of developing various cancers, with important implications for patients and their families. This research investigates a nurse-led approach to increase genetic counseling and testing GCT among adults with solid tumors. Despite guidelines recommending GCT, many patients do not receive it, partly due to barriers in referral by oncologists. The study focuses on improving GCT uptake through enhanced education by oncology nurses in community cancer centers. Participants are randomized into two groups one receiving an enhanced education session led by trained oncology nurses, and the other receiving usual care education. The enhanced education includes detailed information on GCT, eligibility assessment, referral ordering if agreed upon, and follow-up reminders to ensure referrals are processed. Usual care provides standard treatment education without targeted genetic testing information. This pilot study aims to evaluate the effectiveness, acceptability, and feasibility of this nurse-led intervention. During the study, researchers track the percentage of patients who proceed to GCT consultation and referral, as well as timing from referral to consultation and testing completion. The study lasts about nine months, with ongoing monitoring of these outcomes. Patients will receive education sessions, and nurses will facilitate referrals and follow-up communications to support genetic testing uptake. The study is conducted by the University of California, Davis, and focuses on adult cancer patients starting or switching systemic therapy.
CONDITIONS
A Pilot Study of Genetic Testing Uptake Through Enhanced Oncology Nurse-Led Intervention
R
Rachel A Kitchen, CCRP
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University of California, Davis
Lead Sponsor
Enloe Regional Cancer Center
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Enhanced Education (Nurse-Led) | Usual Care Education |
|---|---|---|
| What it is | A multi-component nurse-led process that supplements usual care education for genetic counseling and testing (GCT) by providing additional, accessible information on GCT, proactively placing referrals for eligible patients, distributing easy-to-understand written materials, and delivering follow-up reminders to help complete the referral process. | The standard approach where clinicians provide a brief introduction to genetic counseling and testing using standard materials. Referrals for GCT are made at the clinician’s discretion, without structured nurse involvement or added follow-up beyond routine care. |
| Role in the trial | Intervention arm designed to increase genetic counseling/testing (GCT) uptake through enhanced education, nurse-initiated referral, and proactive reminders. | Comparator arm reflecting current standard education and referral patterns; serves as the reference group for measuring any uptake improvement in the intervention arm. |
| Primary use | To facilitate guideline-concordant referral and completion of genetic counseling/testing for eligible adults with solid tumors by reducing barriers and supporting the testing process with enhanced nurse engagement. | To provide cancer patients a brief introduction to genetic testing and counseling according to standard educational materials, with referral for GCT based on clinician judgment and standard practice guidelines. |
| How it is given or performed | The nurse provides extra education about genetic counseling/testing, gives easy-to-understand written materials, proactively places GCT referrals for eligible patients, and sends electronic follow-up messages to ensure referrals move forward. | A clinician introduces GCT briefly using existing educational resources. Referral for genetic counseling/testing is clinician-initiated only if deemed appropriate during the visit; there is no proactive nurse involvement or further structured follow-up. |
| Evidence status | Ongoing; effectiveness in increasing GCT uptake among eligible adults with solid tumor malignancies is being tested. Prior studies in breast and ovarian cancer settings suggest that nurse navigator or nurse-led strategies may increase the rate of genetic testing completion. | Current standard education and clinician-directed referral yield variable GCT uptake rates. Barriers include lack of awareness, limited provider time, and missed referrals; completion rates are often sub-optimal even when patients are guideline-eligible. |
| Important limitations | This nurse-led intervention requires adequate staffing, training, and workflow support to ensure consistent education and timely referral; implementation in different clinical settings could be variable and dependent on available resources. | Usual care may lead to under-referral or missed opportunities for genetic counseling/testing due to limited time, inconsistent education, or lack of systematic follow-up for eligible patients. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of systemic therapy initiation or switch
Participants receive either enhanced education on genetic counseling and testing led by a trained oncology nurse or the usual care education during their therapy education sessions. The enhanced education includes detailed information on genetic testing and facilitation of referral if eligible and agreeable.
1 therapy education session with oncology nurse
Duration - Up to 9 months
Participants are monitored for uptake of genetic counseling and testing, including referrals and consultations, over the course of the study.
Follow-up assessments during study completion period
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/34322651/University of California, Davis
Lead Sponsor
Enloe Regional Cancer Center
Collaborating Sponsor