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Patient Navigation Program to Improve Clinical Trial Enrollment in Cancer Patients

ConditionsProstate CancerKidney Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: High Intensity ApproachExperimental treatment 1 intervention
Group B: Low Intensity ApproachActive comparator 1 intervention

Trial outcomes

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.

Time frame
18 months

Secondary outcomes

1

Acceptance rate

Acceptance rate of patients on the navigation study.

Time frame
12 months
2

Retention rate

Retention rate of patients on the navigation study

Time frame
18 months

Other outcomes

1

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.

Time frame
18 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead sponsor

WellSpan Health

Collaborator

Source ClinicalTrials.gov
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