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Streamlined Genetic Testing in Prostate Cancer

NCT04359758 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2024-01-17

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

Proactive Streamlined Genetic Education and Testing

This intervention consists of the proactive delivery of genetic education print materials followed by streamlined and facilitated access to genetic testing.

BEHAVIORAL

Usual Care

This intervention consists of a standard genetic referral letter that notified the participant that he qualified for genetic referral, recommends the scheduling of a genetic counseling session and provides a telephone number for scheduling.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Georgetown University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2021-10-01
Completion
2021-11-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04359758 on ClinicalTrials.gov