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NCT Number: NCT06138067

Patient Navigation Program to Improve Clinical Trial Enrollment in Cancer Patients

The goal of this clinical trial is to test the utility of patient navigation by comparing high intensity patient navigation to low intensity navigation approaches to improving cancer trial enrollment of patients treated in academic and community cancer centers. Patient navigation is a strategy for increasing patients access to cancer care by helping the participant overcome barriers in the participants communities and within the health care system by providing a bridge between the patient and the health care system. The primary objective of this study is to determine if a high intensity patient navigation program will improve patients enrollment on clinical trial in comparison to a low intensity patient navigation. Participants who agree to participate and are eligible will be randomly assigned to either the high intensity or low intensity approach.

Recruiting

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Key information

Conditions

Prostate Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Kidney Cancer Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

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About this study

This study is a pilot randomized two arm prospective study of a high versus low intensity patient navigation program with the primary endpoint of clinical trials enrollment rate between the 2 arms. The hypothesis of the study is that a high intensity patient navigation program will improve the enrollment rates on clinical trials. Candidates for this study will already have been identified by the patient navigator as being potentially eligible for a clinical trial. Randomization will be stratified by the type of site: community versus academic. There will be a single futility analysis after approximately 50% of the patients have been randomized and offered a clinical trial. Randomization and data capture will be via REDCap.

The primary endpoint of the study is the enrollment rate on clinical trials. With a sample size of 90 and conservatively assuming a clinical trial enrollment among clinical trial eligible patients of 50%, simulations show the investigators would be able to detect a 25% minimum difference (alternative 75% enrollment) in enrollment rates between the two groups with 84% power using a Z test of proportions with a one-sided alpha level of 0.10.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Age ≥ 18 years
  • Patient with a current diagnosis of a primary solid tumor including: prostate cancer and kidney cancer
  • Being seen at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins University (JHU) or Wellspan Health Center
  • Available therapeutic trial for the patient as determined through pre-screening/medical record review

Treatment and study plan

High intensity approach

Behavioral

PEM, cancer center support services material, and community resources and services available to cancer patients material. The PEM will be reviewed with the patient navigator before the participants appointment with the medical oncologist. If enrolled in a clinical trial, the patient navigator will call the participant biweekly, or more often if they are working to resolve any needs identified in the needs assessment) until the participant is successfully enrolled in the therapeutic clinical trial. The patient navigator will call the participant once weekly for 4 weeks, or less than 4 weeks in other cases including withdrawal from the clinical trial or this navigation study, disease progression, or death. The participant will receive a call 3 months after enrollment on the therapeutic clinical trial to complete the Exit Questionnaire

Low intensity approach

Behavioral

The participant will receive PEM, and community resources and services available to cancer patients material. The PEM will be reviewed with the patient navigator before the appointment with the medical oncologist. The patient navigator will call the participant 4 weeks after enrollment on the trial. The participant will receive a call 3 months after enrollment on the therapeutic clinical trial to complete the Exit Questionnaire

Primary outcomes

  1. Number of patients from high intensity navigation program that enroll in clinical trials

    Time frame: 18 months

    Number of patients from high intensity patient navigation program that enroll in clinical trials versus the number of patients from low intensity patient navigation program that enroll in clinical trials.

Secondary outcomes

  1. Acceptance rate

    Time frame: 12 months

    Acceptance rate of patients on the navigation study.

  2. Retention rate

    Time frame: 18 months

    Retention rate of patients on the navigation study

Other outcomes

  1. Number of different types of barriers to enrollment

    Time frame: 18 months

    To identify type of potential barriers and total quantity of each type to enrollment on clinical trial reported by patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Yasser Ged, MBBS

CONTACT

[email protected]

410-614-2302

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • WellSpan Health

Registry information

Official study title

A Pilot Study of Low Versus High Intensity Patient Navigation Program to Improve the Enrollment on Clinical Trials Among Cancer Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 18, 2023
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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