N/A
N=112
Streamlined Genetic Testing in Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04359758 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Number of Participants Completing Genetic Testing — 22; 15; 31; 39 Participants — p=0.14
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Proactive Streamlined Genetic Education and Testing (Behavioral); Usual Care (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Male
- Sponsor
- Georgetown University
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Completing Genetic Testing |
22; 15; 31; 39 | 0.14 |
| SECONDARY Decision Satisfaction |
21.3; 23.2 | 0.13 |
| SECONDARY Decisional Regret |
26.5; 25.4 | 0.78 |
| SECONDARY Distress |
48.5; 48.4; 47.5; 47.4; 43.6; 47.4 | 0.97 |
Summary
The goal of this pilot randomized controlled trial is to evaluate the impact and efficacy of a streamlined genetic education and testing intervention for men with prostate cancer. Eligible men are prostate cancer survivors who meet criteria for genetic counseling referral. After completing a baseline survey, participants (n=120) are randomized to Streamlined Genetic Testing (ST) or Usual Care (UC). Participants in ST are able to review genetic education materials and then proceed directly to genetic testing. Participants in UC will be provided with a referral for standard individual genetic counseling. Two months after randomization all participants will be contacted to complete a follow-up survey.
Eligibility Criteria
Inclusion Criteria
- Male
- Diagnosed with metastatic prostate cancer or Gleason 7+ prostate cancer
- Diagnosed between 2010-2020
Exclusion Criteria
- Age 81 or older
- Previous cancer genetic counseling or testing
- Previously scheduled for cancer genetic counseling or testing
- Cannot participate in English
- Are not capable of providing informed consent
Data sourced from ClinicalTrials.gov (NCT04359758). 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.