High- vs Low-Intensity Patient Navigation to Increase Patient Participation in Cancer Clinical Programs
Official title: A Pilot Study of Low Versus High Intensity Patient Navigation Program to Improve the Enrollment on Clinical Trials Among Cancer Patients
Run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · NCT06138067 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | September 2027 |
| Study ends | January 2028 |
| Registry record updated | September 3, 2026 |
| Trial ID | NCT06138067 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.