N/A
N=3,073
Broadening the Reach, Impact, and Delivery of Genetic Services
Cancer · Risk Reduction Behavior
Bottom Line
View on ClinicalTrials.gov: NCT03985852 ↗Enrolled (actual)
3,073
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Completion of Genetic Testing From Electronic Health Record — 191; 206 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient Directed Standard of Care (Other)
- Age
- Adult · 25+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Completion of Genetic Testing From Electronic Health Record |
191; 206 | — |
| SECONDARY Completion of Pre-test Genetic Counseling From Electronic Health Record |
400; 361 | — |
| SECONDARY Adherence to Colonoscopy: Questionnaire |
17; 24 | — |
Summary
The purpose of this study is to compare the uptake of genetic testing among patients randomized with two different models of genetic services delivery (a patient-directed model and an enhanced standard of care model) and examine whether the impact on uptake differs by race/ethnicity and rurality. This study will also compare the effect of these delivery models on adherence to cancer prevention and screening recommendations and other patient responses.
Eligibility Criteria
Inclusion Criteria
- Speaks English or Spanish
AND
- First degree relative or second degree relative diagnosed with the following regardless of age: Ovarian Cancer, Pancreas Cancer
OR
- First degree relative or second degree relative diagnosed with the following <50 years of age: Breast Cancer, Colorectal Cancer, Endometrial Cancer.
OR
- Three of more relatives on the same side of the family diagnosed with the following clusters of cancer regardless of age:
- Breast Cancer, Ovarian Cancer, Pancreas Cancer, Prostate Cancer
- Colorectal Cancer, Endometrial Cancer, Ovarian Cancer, Pancreas Cancer, Urinary tract, Brain, Small intestine
- Melanoma, Pancreas Cancer
OR
- Ashkenazi Jewish ancestry and family history of Breast Cancer, Ovarian Cancer, Pancreas Cancer, Prostate Cancer.
Exclusion Criteria
- Patients with a prior cancer diagnosis, other than non-melanoma skin cancer, and/or prior genetic counseling or testing related to hereditary cancer.
- Patients unable to access the patient portal
Data sourced from ClinicalTrials.gov (NCT03985852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.