High- vs Low-Intensity Patient Navigation to Increase Patient Participation in Cancer Clinical Programs
A Pilot Study of Low Versus High Intensity Patient Navigation Program to Improve the Enrollment on Clinical Trials Among Cancer Patients
This project tests whether a high-intensity patient navigation program helps adults with prostate or kidney cancer enroll in clinical trials more than a lower-intensity navigation approach.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT06138067 on ClinicalTrials.gov |
What this trial studies
This is a randomized, two-arm pilot comparing high-intensity versus low-intensity patient navigation to increase clinical trial enrollment among adults with solid tumors treated at academic and community centers. Candidates are pre-identified by a navigator as potentially eligible for an available therapeutic clinical trial and then randomized, with stratification by site type (academic versus community). The primary endpoint is the proportion of patients who enroll on a clinical trial; the study plans 90 participants with a single futility analysis after about 50% have been randomized. Randomization and data capture are managed in REDCap and the trial compares enrollment rates between arms to detect a 25% absolute difference with pre-specified statistical thresholds.
Who should consider this trial
Good fit: Adults (≥18) with a current primary solid tumor such as prostate or kidney cancer who are being seen at Johns Hopkins SKCCC or WellSpan and have an available therapeutic trial identified by pre-screening are ideal candidates.
Not a fit: Patients who do not have an available therapeutic clinical trial option, who are not treated at the participating sites, or who are under 18 are unlikely to benefit from enrollment in this program.
Why it matters
Potential benefit: If successful, a high-intensity navigation program could substantially increase patient access to clinical trials and broaden who enrolls in experimental cancer treatments.
How similar studies have performed: Patient navigation has improved access to cancer care in other settings and some programs have increased trial participation, but randomized comparisons of high- versus low-intensity navigation for trial enrollment are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland and 1 other locations
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States (Recruiting)
- Wellspan — Chambersburg, Pennsylvania, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Yasser Ged, MBBS — Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Study coordinator: Yasser Ged, MBBS
- Email: yged1@jhmi.edu
- Phone: 410-614-2302
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.