UNC trial tests navigation support for rural endometrial cancer care
UNC Lineberger Comprehensive Cancer Center is recruiting for a patient navigation study designed to close access gaps for women with endometrial cancer who live far from the University of North Carolina Hospital or who identify as Black or African American. The pilot, registered as NCT07927244, is built around a practical premise: treatment planning is only the first hurdle for many patients, and the burden of travel, communication barriers, financial strain, and fragmented care can quickly erode adherence to oncology visits. In a disease where delays can alter the pace of treatment decisions and the ability to move from consultation to therapy, a navigation program can function as a clinical bridge rather than an administrative add-on.
The study is open to adults with a newly diagnosed or recurrent endometrial cancer diagnosis who are undergoing treatment planning at UNC, reside more than 25 miles from the hospital, and can complete study procedures in English. Enrollment is estimated at 50 participants, with the intervention framed as a single-group, open-label behavioral program rather than a drug trial. Because the project is positioned as health services research, the main question is not whether navigation can cure cancer; it is whether a structured support model can be delivered reliably to patients with the highest barriers to care.
A risk-stratified navigation model built around treatment milestones
The intervention uses three structured touchpoints: a pre-consult assessment, a pre-treatment assessment, and an active-treatment assessment. Each visit follows scripted, semi-structured interview guides, allowing the navigator to identify immediate needs and tailor support over time. Before consultation, the navigator can provide individualized financial and transportation resources. During pre-treatment and active-treatment phases, additional support is layered in based on each patient’s circumstances.
A Navigation Assessment Score determines how often follow-up occurs. The score incorporates a mix of risk factors that are familiar to any oncology team working with underserved populations: age, long travel distance, language needs, food insecurity, financial strain, lack of internet access, metastatic disease, living alone, and other social or health risks. Low-risk patients receive one follow-up, intermediate-risk patients receive two, and high-risk patients receive weekly follow-ups during treatment. Patients can also contact the navigator at any time, which may matter as much as the scheduled touchpoints themselves. In real care settings, the need for help rarely arrives on a predictable timetable.
The program is also built to be virtual whenever possible. That matters in a population defined partly by geography, because transportation barriers can compound each stage of oncology care—from the first discussion of surgery or radiation through treatment logistics, symptom management, and insurance navigation. Virtual contact does not erase structural barriers, but it can narrow the distance between a patient and the care team enough to keep treatment on track.
Fidelity is the primary endpoint, not survival
The study’s primary endpoint is fidelity of the navigation intervention. Investigators will judge fidelity by the proportion of participants who receive and complete the number of patient navigation assessments assigned to their risk category. For low-risk participants, the benchmark includes at least one active-treatment assessment and one follow-up assessment during treatment. Intermediate-risk participants must complete at least one active-treatment assessment and two follow-up assessments. High-risk participants must complete at least one active-treatment assessment and three follow-up assessments. Completion data will be captured in REDCap.
This is a meaningful choice for a pilot. Before a navigation program can be tested for downstream effects on treatment completion, symptom burden, or health outcomes, the model has to prove that it can be delivered as designed. A care pathway can look elegant on paper and still unravel when patients miss visits, cannot be reached, or are unable to act on referrals. Fidelity is the first clinical stress test.
The protocol also reflects a sober understanding of implementation science: the value of navigation is tied to repetition, not a one-time counseling session. Repeated touchpoints can identify transportation gaps before appointments are missed, surface financial barriers before bills spiral, and connect patients to services before stress becomes disengagement. For marginalized patients with gynecologic cancer, those functions can shape whether treatment begins on schedule and whether it continues without avoidable interruptions.
Recruitment, retention, and patient experience will help define feasibility
Secondary endpoints extend beyond fidelity to include recruitment rate, retention rate, acceptability, and cost. Recruitment will be measured as the proportion of eligible individuals who enroll. Retention will track how many participants complete at least one navigation assessment after enrollment. Acceptability will be assessed with post-intervention Patient Satisfaction with Navigator Interpersonal Relationship scores, using a 9-item scale scored from 1 to 5, for a possible range of 9 to 45. Cost will be estimated by multiplying intervention delivery time by the navigator’s hourly salary.
Those measures are not secondary in practical terms. If the program is too difficult to staff, too slow to deploy, or too burdensome for patients to use, the model will not scale beyond a pilot cohort. Conversely, a navigation intervention that patients trust, understand, and use consistently could become a template for broader support in gynecologic oncology clinics that care for patients living outside major urban centers.
Rurality, race, and the burden of delayed access in endometrial cancer
The study’s eligibility criteria make its equity focus explicit. It targets adults with endometrial cancer who live more than 25 miles from the treatment center and includes patients who self-identify as Black or African American, groups recognized within the protocol as facing higher mortality. That framing reflects a long-standing problem in oncology: disparities are often produced less by one single barrier than by the cumulative effect of distance, money, time, digital access, and inconsistent communication.
Endometrial cancer care depends on coordination. Patients may need surgery, radiation, systemic therapy, or a mix of modalities, and each step requires scheduling, travel, symptom monitoring, and follow-through. When the care plan becomes difficult to navigate, the disease is not the only burden patients carry. A navigation program is meant to reduce the friction around treatment so that medical decisions can proceed without unnecessary delay.
The trial is scheduled to begin with an actual start date of May 9, 2025, and has estimated completion on December 23, 2026. With no results posted yet, the study remains at the feasibility stage. Its most important unanswered questions are operational ones: can the intervention reach the patients who need it, can the protocol be followed closely enough to be meaningful, and can the work be delivered at a cost that makes further testing realistic? Those answers will determine whether this navigation model can move from pilot study to a larger cancer care strategy.