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Not yet recruiting NCT07377006

Decision Support Tool to Enhance Germline Genetic Testing for Patients With Prostate Cancer

No phase Interventional Prostate Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Behavioral Intervention, Biospecimen Collection, Electronic Health Record Review, Genetic Counseling.
Who it may be relevant to
Registry conditions: Prostate Carcinoma. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efforts to Enhance Germline Genetic Testing at Lyndon B. Johnson Hospital

Overview

This clinical trial identifies factors associated with completing genetic testing, aids in the development of a decision support tool, and tests how well the decision support tool works to enhance germline genetic testing in patients with prostate cancer. Germline genetic testing is a guideline-recommended standard of care for many patients with prostate cancer. Completing genetic testing can enable the use of targeted therapies, offers access to novel clinical trials, provides valuable information, and can help identify at risk family members. The decision support tool may educate patients and assist in the decision to engage with germline genetic testing.

Detailed description

PRIMARY OBJECTIVES:

I. Identify patient, provider, and health system factors contributing to the completion of recommended germline testing for men with prostate cancer.

II. Develop a decision support tool for patients tailored to the cultural and socioeconomic context of the local community.

III. Conduct a pilot intervention trial to evaluate a point-of-care decision support tool in a public safety net hospital in Harris County, Texas.

SECONDARY OBJECTIVES:

I. Assess the feasibility of point-of-care decision support tool in a public safety net hospital in Harris County, Texas.

II. Assess the change in completion of germline genetic testing with utilization of the decision support tool.

OUTLINE: At each stage of the proposed research, patients are recruited to 1 of 3 groups. Groups 1 and 2 are observational and group 3 is a pilot interventional trial.

GROUP 1: Patients complete a qualitative interview that informs the development of the decision support tool.

GROUP 2: Patients view the draft of the decision support tool and complete cognitive interviews for the refinement of the decision support tool on study.

GROUP 3: Patients view the decision support tool that provides culturally tailored information about genetic testing and the collection process. Patients may then provide a blood sample for standard of care genetic testing and may additionally meet with a genetics counselor for additional information prior to testing. Patients with a positive germline genetic mutation will discuss results with a genetics counselor.

Interventions

  • Behavioral Behavioral Intervention
    View decision support tool
  • Procedure Biospecimen Collection
    Undergo blood sample collection
  • Other Electronic Health Record Review
    Ancillary studies
  • Other Genetic Counseling
    Meet with genetic counselor
  • Other Genetic Testing
    Undergo standard of care genetic testing
  • Other Interview
    Complete qualitative interview
  • Other Interview
    Complete cognitive interview
  • Other Survey Administration
    Ancillary studies

Primary outcome measures

  • Safety and Adverse Events (AEs) [Time frame: Through study completion; an average of 1 year]

Eligibility criteria

Inclusion criteria

  • Diagnosed prostate cancer patients receiving care at Lyndon B. Johnson (LBJ) Hospital
  • Were recommended for germline genetic testing by their oncology provider
  • Can provide informed consent
  • Can communicate in English or Spanish

Exclusion criteria

  • Prostate cancer patients receiving care at LBJ who are unable to participate due to a serious psychological or cognitive condition

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT07377006 · 2025-1272 · NCI-2025-06571 · 2025-1272

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗