Streamlined Genetic Testing in Prostate Cancer
2 other identifiers
interventional
112
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable prostate-cancer
Started Mar 2020
Shorter than P25 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 21, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedResults Posted
Study results publicly available
December 22, 2022
CompletedJanuary 17, 2024
January 1, 2024
1.6 years
April 21, 2020
October 26, 2022
January 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Completing Genetic Testing
Receipt of genetic testing results as indicated in clinic records
Three Months Post-Randomization
Secondary Outcomes (3)
Decision Satisfaction
3 Months Post Randomization
Decisional Regret
3 Months Post Randomization
Distress
3 Months Post Randomization
Study Arms (2)
Proactive Streamlined Genetic Education and Testing
EXPERIMENTALParticipants randomized to this arm will proactively receive genetic education print materials and the option to proceed directly with genetic testing.
Usual Care
ACTIVE COMPARATORParticipants in this arm will be sent a referral letter recommending that they schedule a genetic counseling session and providing them with contact information to do so.
Interventions
This intervention consists of the proactive delivery of genetic education print materials followed by streamlined and facilitated access to genetic testing.
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.
Eligibility Criteria
You may qualify if:
- Male
- Diagnosed with metastatic prostate cancer or Gleason 7+ prostate cancer
- Diagnosed between 2010-2020
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Georgetown Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Georgetown University Medical Center/Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Small sample size due to the the fact that this was a pilot trial. This impacted statistical power and ability to conduct subgroup analyses.
Results Point of Contact
- Title
- Marc D. Schwartz, PhD
- Organization
- Georgetown Lombardi Comprehensive Cancer center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Oncology
Study Record Dates
First Submitted
April 21, 2020
First Posted
April 24, 2020
Study Start
March 1, 2020
Primary Completion
October 1, 2021
Study Completion
November 1, 2021
Last Updated
January 17, 2024
Results First Posted
December 22, 2022
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, ANALYTIC CODE
- Time Frame
- 12-36 months after publication.
- Access Criteria
- Investigator who proposes to use the data must obtain approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execute a data use/sharing agreement with Georgetown University.
Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with Georgetown University.