Patient Navigation Program to Improve Clinical Trial Enrollment in Cancer Patients

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

Study Overview

• Status: Not yet recruiting
• Conditions: Kidney Cancer; Prostate Cancer
• Intervention / Treatment: Behavioral: High intensity approach; Behavioral: Low intensity approach

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yasser Ged, MBBS; Phone Number: 410-614-2302; Email: yged1@jhmi.edu

Study Locations

• United States
  • Pennsylvania
    • Chambersburg, Pennsylvania, United States, 17201
      • WellSpan
      • Contact: Kibem Kim, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Intensity Approach; Patients will receive printed educational material (PEM) which will include information and resources regarding clinical trials/clinical trial participation, cancer center support services; and community resources and services available to cancer patients. The PEM will be reviewed by the clinical trial patient navigator with the patient prior to the clinic visit with the medical oncologist. If the patient is offered participation in a therapeutic clinical trial, the high intensity patient navigation begins. The patient navigator will arrange to meet with the patient to complete a needs assessment to identify and address barriers to trial participation within one week of the visit with the medical oncologist (and clinical trial offer).	Behavioral: High intensity approach; 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
Active Comparator: Low Intensity Approach; Patients will receive printed educational material (PEM) which will include information and resources regarding clinical trials/clinical trial participation and community resources and services available to cancer patients. The PEM will be reviewed by the patient navigator with the patient prior to the clinic visit with the medical oncologist.	Behavioral: Low intensity approach; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients from high intensity navigation program that enroll in clinical trials	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.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance rate	Acceptance rate of patients on the navigation study.	12 months
Retention rate	Retention rate of patients on the navigation study	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of different types of barriers to enrollment	To identify type of potential barriers and total quantity of each type to enrollment on clinical trial reported by patients.	18 months

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: WellSpan Health
• Investigators: Principal Investigator: Yasser Ged, MBBS, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: clinical trials enrollment rate
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Neoplasms
• Other Study ID Numbers: J23132; IRB00412107 (Other Identifier: JHM IRB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No