Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06436157

Genetic Testing Uptake Through an Enhanced Oncology Nurse-Led Intervention in Patients With Solid Tumors (GENESIS): A Pilot Study

Led by University of California, Davis · Updated on 2025-01-31

60

Participants Needed

2

Research Sites

26 weeks

Total Duration

On this page

Sponsors

U

University of California, Davis

Lead Sponsor

E

Enloe Regional Cancer Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults (≥ 18 years)
  • Diagnosed with a solid tumor cancer type with established guidelines supporting genetic testing (e.g., breast, ovarian, prostate, pancreatic, colon, Lynch syndrome-related cancers, Li-Fraumeni syndrome tumor spectrum)
  • Eligible for genetic counseling and testing based on current NCCN guidelines
  • Starting new systemic therapy or switching systemic therapy
  • No prior genetic testing or tested before 2014
Not Eligible

You will not qualify if you...

  • Prior genetic counseling and testing with available results since 2014
  • Scheduled for treatment education with Advanced Practice Provider
  • Cognitive impairments or severe psychological disorders limiting understanding or consent
  • Conditions posing safety concerns with study procedures (e.g., urgent therapy needs, inpatient chemotherapy initiation)
  • Currently participating in other clinical trials that may affect genetic testing outcomes
  • Inability to comply with study procedures
  • Hematologic malignancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Enhanced Education Intervention or Usual Care Education

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

Follow-up Monitoring

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

Trial Site Locations

Total: 2 locations

1

Enloe Regional Cancer Center

Chico, California, United States, 95926

Actively Recruiting

2

University of California, Davis

Sacramento, California, United States, 95616

Active, Not Recruiting

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Research Team

R

Rachel A Kitchen, CCRP

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Time Trends in Receipt of Germline Genetic Testing and Results for Women Diagnosed With Breast Cancer or Ovarian Cancer, 2012-2019.

Allison W Kurian, Kevin C Ward, Paul Abrahamse...

https://pubmed.ncbi.nlm.nih.gov/33560870

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

Implementation of Nurse Navigation Improves Rate of Molecular Tumor Testing for Ovarian Cancer in a Gynecologic Oncology Practice.

Taylor A Rives, Heather Pavlik, Ning Li...

https://pubmed.ncbi.nlm.nih.gov/37370804

Urban-Rural and Socioeconomic Differences in Patient Knowledge and Perceptions of Genomic Tumor Testing.

Jessica F DiBiase, Elizabeth Scharnetzki, Emily Edelman...

https://pubmed.ncbi.nlm.nih.gov/36893376

Multicenter Prospective Cohort Study of the Diagnostic Yield and Patient Experience of Multiplex Gene Panel Testing For Hereditary Cancer Risk.

Gregory E Idos, Allison W Kurian, Charité Ricker...

https://pubmed.ncbi.nlm.nih.gov/34322651

Comparison of Universal Genetic Testing vs Guideline-Directed Targeted Testing for Patients With Hereditary Cancer Syndrome.

N Jewel Samadder, Douglas Riegert-Johnson, Lisa Boardman...

https://pubmed.ncbi.nlm.nih.gov/33126242