Decision Support Tool for Prostate Cancer

Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to create and test a decision support tool to help prostate cancer patients understand and complete genetic testing. Genetic testing can guide targeted treatments and provide valuable family health information. The trial involves different groups: some will contribute to the tool's development through interviews, while others will test the tool and may participate in genetic testing. It is designed for prostate cancer patients at Lyndon B. Johnson Hospital who have been recommended for genetic testing by their doctor and can communicate in English or Spanish. As an unphased trial, this study offers patients the opportunity to contribute to a tool that could enhance their understanding and decision-making regarding genetic testing.

What prior data suggests that this decision support tool is safe for enhancing genetic testing in prostate cancer patients?

Research has shown that decision support tools, like the one used in this trial, are generally safe. They help patients make informed choices without causing harm. For instance, studies have found that these tools can speed up decision-making for both patients and doctors. A review of different decision aids found no major safety issues, indicating they are well-tolerated. Thus, using the decision support tool in the trial should not harm participants.12345

Why are researchers excited about this trial?

Researchers are excited about the Decision Support Tool for prostate cancer because it offers a personalized approach to understanding genetic testing. Unlike traditional treatments that focus solely on managing the cancer itself, this tool provides culturally tailored information, helping patients make informed choices about genetic testing. Additionally, it facilitates discussions with genetics counselors, enhancing patient understanding and engagement in their care. This tailored approach could empower patients with more control over their health decisions, potentially improving outcomes and satisfaction with their care.

What evidence suggests that this decision support tool is effective for enhancing genetic testing in prostate cancer patients?

Research has shown that decision support tools help people make better-informed choices about prostate cancer care. Some studies found that these tools can reduce the time needed to make clinical decisions by up to 94%. Other research suggests that decision aids improve patients' understanding of their treatment options without altering actual screening rates. Overall, these tools guide patients through personalized treatment choices and enhance communication with healthcare providers. In this trial, participants will use a decision support tool designed to assist patients with prostate cancer in completing genetic testing and making informed care decisions.24678

Who Is on the Research Team?

DP

Debanjan Pain

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with prostate cancer who may benefit from genetic testing. It aims to help them decide whether to undergo germline genetic testing, which can guide treatment choices and identify family members at risk.

Inclusion Criteria

Can provide informed consent
My oncologist recommended genetic testing for me.
I am being treated for prostate cancer at LBJ Hospital.
See 1 more

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Qualitative Interview

Patients complete a qualitative interview that informs the development of the decision support tool

4 weeks
1 visit (in-person)

Cognitive Interview

Patients view the draft of the decision support tool and complete cognitive interviews for refinement

4 weeks
1 visit (in-person)

Pilot Intervention

Patients view the decision support tool and may provide a blood sample for genetic testing

4 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Decision Support Tool

Trial Overview

The study tests a decision support tool designed to encourage prostate cancer patients to complete germline genetic testing. This involves surveys, interviews, electronic health record reviews, counseling, and biospecimen collection.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Group 3 (Decision tool)Experimental Treatment5 Interventions
Group II: Group 2 (Draft decision support tool, cognitive interview)Experimental Treatment2 Interventions
Group III: Group 1 (Qualitative interview)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Citations

Decision Making in Prostate Cancer Screening Using ... - PMC

Both decision aids improved participants' informed decision making about PCa screening up to 13 months later but did not affect actual screening rates.

Clinical decision making in prostate cancer care ...

The application of the decisions support tool led to a highly significant reduction of overall time (-94%) required for the entire clinical ...

Building a Digital Tool for Prostate Cancer Decision-making

The first evidence-based online tool to guide recently diagnosed prostate cancer patients through a personalized treatment decision.

Decision Aids for Prostate Cancer Screening Choice

This systematic review and meta-analysis of 19 randomized clinical trials estimates the association of decision aids with decisional ...

Effects of a Patient Decision Aid for Nonmetastatic Prostate ...

The primary outcome was treatment decision after 14 mo. The secondary endpoints were knowledge, acceptance, decisional conflict, physician-patient communication ...

Decisional outcomes following use of an interactive web ...

We evaluated the extent to which use of an interactive, web-based decision aid was associated with decisional and screening outcomes.

An Online Treatment Decision Aid for Men with Low-risk ...

Examining the effectiveness and implementation of patient treatment decision-aid tools for men with localised prostate cancer: a systematic review.

Validation and implementation of a mobile app decision ...

Overall, our results suggest that EO is a promising tool to assist clinicians in providing reliable treatment recommendations for prostate cancer patients.