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Trial Title:
Patient Navigation Program to Improve Clinical Trial Enrollment in Cancer Patients
NCT ID:
NCT06138067
Condition:
Prostate Cancer
Kidney Cancer
Conditions: Official terms:
Kidney Neoplasms
Conditions: Keywords:
clinical trials enrollment rate
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
High intensity approach
Description:
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
Arm group label:
High Intensity Approach
Intervention type:
Behavioral
Intervention name:
Low intensity approach
Description:
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
Arm group label:
Low Intensity Approach
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Wellspan
Address:
City:
Chambersburg
Zip:
17201
Country:
United States
Contact:
Last name:
Kibem Kim, MD
Start date:
November 1, 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agency class:
Other
Collaborator:
Agency:
WellSpan Health
Agency class:
Other
Source:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06138067
