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Physician- and Patient-based Barriers to NGS Testing

NCT ID: NCT07209176

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-15

Study Completion Date

2027-09-01

Brief Summary

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The goal of this study is to improve next-generation sequencing (NGS) testing rates at Johns Hopkins in patients with metastatic prostate cancer. Investigators believe by targeting two barriers, provider-level and patient-level, will improve the testing rate of NGS at Johns Hopkins.

Detailed Description

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Next-generation sequencing is recommended by national guidelines in metastatic prostate cancer to inform prognosis, treatment decisions, and eligibility for clinical trials. However, rates are low nationally and around 50-60% at Johns Hopkins. Analysis found that older patients and patients who are not married are less likely to have testing performed. The goals and objectives of this proposed clinical trial are to improve NGS testing rates at Johns Hopkins using a multidisciplinary approach to improve the care of patients living with metastatic prostate cancer and reduce disparities. The hypothesis is that this initiative, which targets two barriers (provider-level and patient-level), will lead to higher rates of NGS ordering at Johns Hopkins.

Conditions

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Metastatic Prostate Cancer

Keywords

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metastatic prostate cancer next-generation sequencing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Provider nudge and patient education at time of enrollment

The provider level component (implemented for all patients) will be a "nudge" to physicians to order testing via a single email documenting their NGS testing rate relative to the Johns Hopkins top performer and, for those not in the top 20%, a link to the most recent American Society of Clinical Oncology (ASCO) guidelines recommending testing. In addition, there will be a patient component that is a one-page handout of educational material about NGS testing to be sent after their initial visit via email or mail.

Group Type EXPERIMENTAL

Provider-level and patient-level

Intervention Type OTHER

In addition to the provider component, patients will also receive a one-page patient educational material (via email, or mail if no email on file) on advanced prostate cancer that includes education on somatic NGS testing. The email will be sent by the MyChart Recruitment Innovation team. Those without email on file will have the same message and attachment sent via mail by our study coordinator.

Provider component and patient education at end of study

The provider level component (implemented for all patients) will be a "nudge" to physicians to order testing via a single email documenting their NGS testing rate relative to the Johns Hopkins top performer and, for those not in the top 20%, a link to the most recent ASCO guidelines recommending testing. The patient educational material will be provided by email or mail (if no email on file) to those who randomized to this arm.

Group Type EXPERIMENTAL

Provider-level and patient education at end of study

Intervention Type OTHER

The provider level component will involve an email to each of the genitourinary medical oncologists at Johns Hopkins with their NGS testing rate from preliminary data and compare this rate to the mean. The initial email will also include the 2025 ASCO guideline recommending somatic testing in virtually all metastatic prostate cancer patients. Providers who do not have baseline NGS testing rates available will also be emailed. Providers will subsequently be emailed their updated NGS testing rate at the conclusion of the study period.

Patients will also receive a one-page patient educational material (via email, or mail if no email on file) on advanced prostate cancer that includes education on somatic NGS testing at the end of the study period.

Interventions

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Provider-level and patient education at end of study

The provider level component will involve an email to each of the genitourinary medical oncologists at Johns Hopkins with their NGS testing rate from preliminary data and compare this rate to the mean. The initial email will also include the 2025 ASCO guideline recommending somatic testing in virtually all metastatic prostate cancer patients. Providers who do not have baseline NGS testing rates available will also be emailed. Providers will subsequently be emailed their updated NGS testing rate at the conclusion of the study period.

Patients will also receive a one-page patient educational material (via email, or mail if no email on file) on advanced prostate cancer that includes education on somatic NGS testing at the end of the study period.

Intervention Type OTHER

Provider-level and patient-level

In addition to the provider component, patients will also receive a one-page patient educational material (via email, or mail if no email on file) on advanced prostate cancer that includes education on somatic NGS testing. The email will be sent by the MyChart Recruitment Innovation team. Those without email on file will have the same message and attachment sent via mail by our study coordinator.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* men diagnosed with metastatic prostate cancer
* seen by Johns Hopkins Medical Oncology as a new patient visit between January 1, 2025 and December 31, 2026

Exclusion Criteria

\- Patients who have already had NGS testing performed.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine Marshall, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Central Contacts

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Catherine Marshall, MD

Role: CONTACT

Phone: 410-955-0231

Email: [email protected]

Maddie Klugman

Role: CONTACT

Phone: 410-955-8893

Email: [email protected]

Other Identifiers

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IRB00505965

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00505965

Identifier Type: -

Identifier Source: org_study_id