Testing a new model for cancer genetics counseling in metastatic breast cancer patients
Efficacy of Point Of Service Testing in Metastatic Breast Cancer
This study tests a new way to provide genetic counseling right at the doctor's office for people with HER2 negative metastatic breast cancer to see if it helps them feel more satisfied and get better support.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT03983577 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a point of service delivery model for genetic counseling in patients with metastatic breast cancer who have been referred for hereditary cancer genetic testing. The approach aims to provide timely and accessible genetic counseling directly at the point of care. Participants must have HER2 negative metastatic breast cancer and be enrolled in a parent registry study. The study seeks to determine if this innovative model improves patient outcomes and satisfaction with genetic counseling services.
Who should consider this trial
Good fit: Ideal candidates are patients with HER2 negative metastatic breast cancer who can provide informed consent and are enrolled in the parent registry study.
Not a fit: Patients who have undergone genetic testing for BRCA mutations after 2013 or those with psychiatric conditions that limit compliance may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance access to genetic counseling for metastatic breast cancer patients, leading to better-informed treatment decisions.
How similar studies have performed: While there is limited data on this specific point of service model, similar approaches in genetic counseling have shown promise in improving patient access and outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent. * Able to speak and read in the English language. * Have a diagnosis of human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer. * Participants must be enrolled in the parent registry study. Exclusion Criteria: * Genetic testing for a breast cancer gene (BRCA) BRCA1 and BRCA2 mutation completed after 2013 or any BRCA 1 and BRCA2 testing with large rearrangement testing. Prior genetic counseling is allowed. * Psychiatric illness/social situations that would limit compliance with study requirements.
Where this trial is running
Kansas City, Kansas
- The University of Kansas Cancer Center, Westwood Campus — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Lauren Nye, MD — University of Kansas
- Study coordinator: CT Nurse Navigator
- Email: ctnursenav@kumc.edu
- Phone: 913-945-7552
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.