Physician- and Patient-based Barriers to NGS Testing

NCT07209176 | Recruiting

• 1 other identifier: IRB00505965
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Prostate Cancer

Keywords

metastatic prostate cancer; next-generation sequencing

Outcome Measures

Primary Outcomes (1)

• Rate of Next-Generation Sequencing (NGS) testing by arm

  1 year

Secondary Outcomes (1)

• Percentage of patients with sociodemographic and clinical characteristics who have had NGS testing compared to those without NGS testing during the study period.

  1 year

Study Arms (2)

Provider nudge and patient education at time of enrollment

EXPERIMENTAL

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.

Other: Provider-level and patient-level

Provider component and patient education at end of study

EXPERIMENTAL

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.

Other: Provider-level and patient education at end of study

Interventions

Provider-level and patient education at end of study 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.

Provider component and patient education at end of study

Provider-level and patient-level 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 nudge and patient education at time of enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Patients who have already had NGS testing performed.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Pfizer: collaborator

Study Sites (1)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Catherine Marshall, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Marshall, MD

CONTACT

410-955-0231; chm@jhmi.edu

Maddie Klugman

CONTACT

410-955-8893; mklugma2@jh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 6, 2025
• Study Start: January 6, 2026
• Primary Completion (Estimated): September 6, 2027
• Study Completion (Estimated): September 6, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

US (1)