Patient Navigation Program to Improve Clinical Trial Enrollment in Cancer Patients

NCT06138067 | Recruiting

• 2 other identifiers: J23132IRB00412107
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Prostate Cancer; Kidney Cancer

Keywords

clinical trials enrollment rate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Acceptance rate

  12 months

• Retention rate

  18 months

Other Outcomes (1)

• Number of different types of barriers to enrollment

  18 months

Study Arms (2)

High Intensity Approach

EXPERIMENTAL

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

Low Intensity Approach

ACTIVE COMPARATOR

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

Interventions

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

High Intensity Approach

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

Low Intensity Approach

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (2)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21205, United States

RECRUITING

Wellspan

Chambersburg, Pennsylvania, 17201, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Kidney 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; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases

Study Officials

• Yasser Ged, MBBS

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasser Ged, MBBS

CONTACT

410-614-2302; yged1@jhmi.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: November 13, 2023
• First Posted: November 18, 2023
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (2)