Patient Navigation Program to Improve Clinical Trial Enrollment in Cancer Patients

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06138067
• Other study ID #: J23132
• Secondary ID: IRB00412107
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: September 2026

Study information

• Verified date: February 2024
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: Yasser Ged, MBBS
• Phone: 410-614-2302
• Email: yged1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: September 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Cancer
• Kidney Neoplasms
• Prostate Cancer

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Wellspan	Chambersburg	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	WellSpan Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Acceptance rate	Acceptance rate of patients on the navigation study.	12 months
Secondary	Retention rate	Retention rate of patients on the navigation study	18 months