Improving Rural Endometrial Cancer Care
Endometrial Cancer
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- Female
- Healthy volunteers
- Not accepted
- Participants
- 50 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
This is a pilot feasibility study to enable intensive outreach for marginalized patients with endometrial cancer (EC). Rural residents as well as patients who self-identify as Black or African American patients with EC have higher mortality rates. This study aims to introduce a treatment focused patient navigation intervention for marginalized patients with EC to address the multiple barriers these patients face. Patient navigation is a personalized program to help patients navigate the health care system and access medical and non-medical services. For example, patient navigators can provide services such as mediating/facilitating communication between patients and their providers/health care team, advocating for patient needs, identifying financial assistance and insurance-related resources, coordinating complex patient care, and providing patients with psychosocial support. This study will assess the implementation and effectiveness of a navigation intervention targeting multilevel barriers to care. The primary objective is to evaluate the fidelity of following the patient navigation intervention protocol.
Read the full description
After eligibility and consent, patients complete a brief pre-intervention questionnaire about their well-being, social support, and confidence in managing their care. They then begin the navigation program, which includes three structured assessments: a pre-consult assessment, a pre-treatment assessment, and an active-treatment assessment. These follow scripted, semi-structured interview guides.
During the pre-consult assessment, the navigator offers individualized financial and transportation resources. During the pre-treatment and active-treatment assessments, the navigator offers additional resources tailored to each patient's needs.
Each patient receives a Navigation Assessment Score based on several risk factors (such as age, long travel distance, language needs, food insecurity, financial strain, lack of internet, metastatic disease, living alone, and other social or health risks). The score determines how often the navigator follows up: low-risk patients receive one follow-up, intermediate-risk receive two, and high-risk receive weekly follow-ups during treatment. Patients may also contact the navigator at any time for support.
At the end of the program, patients complete a post-intervention survey to reassess well-being, support, and self-efficacy, and to evaluate how acceptable and helpful they found the navigation program. All assessments can be completed virtually.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Subject is willing and able to comply with study procedures.
- Age ≥ 18 years at the time of consent.
- Resides in a \>25 miles between a patient's home and University of North Carolina Hospital
- patients who self-identify as Black or African American race
- Newly diagnosed or recurrent diagnosis of endometrial cancer undergoing treatment planning at University of North Carolina
Exclusion Criteria:
- Patients who are not receiving treatment within the UNC health care system
- Non-English-speaking patients
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
Rural cancer patients
Endometrial cancer patients located over 25 miles away from treatment center
Behavioral: The patient-navigation program
The patient-navigation program BEHAVIORAL
patients begin the navigation program, which includes three structured assessments: a pre-consult assessment, a pre-treatment assessment, and an active-treatment assessment.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Fidelity of the navigation intervention
Time frame: Up to 12 months
Fidelity will be measured as the proportion of participants who receive and complete a certain number of patient navigation assessments, where the number of assessments is based on their risk category. For low-risk patients, patients who complete at least one active treatment assessment and one follow-up assessment in the treatment period; for medium-risk patients, patients who complete at least one active treatment assessment and two follow-up assessments in the treatment period; for high-risk patients, patients who complete at least one active treatment assessment and three follow-up assessments in the treatment period will be considered in the numerator. The navigator will inform on the completion of assessments and the data will be kept and accessed via RedCAP.
Secondary measures
Recruitment rate
Time frame: Baseline
Recruitment rate is defined as the proportion of individuals enrolled in the patient navigation intervention divided by the number of individuals eligible to participate in patient navigation program.
Retention rate
Time frame: Up to 12 months
Retention rate is defined as the number of individuals who complete one patient navigation assessment, divided by the number of individuals enrolled in the patient navigation program.
Acceptability rate
Time frame: Up to 12 months
Acceptability rate will be measured and described using the post-intervention Patient Satisfaction with Navigator Interpersonal Relationship (PSN-I) scores. PSN-I scale consists of 9 items, each rated on a 5-point Likert scale that typically ranges from: 1 = lowest satisfaction and 5 = highest satisfaction. Max score value is 45 while minimum score value is 9.
Cost
Time frame: Up to 12 months
Cost will be measured by multiplying time required to delivery intervention with patient navigator hourly salary.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
University of North Carolina at Chapel Hill, Department of Radiation OncologyChapel Hill, North Carolina, United StatesRecruiting
Study team and timeline
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Study start
- May 9, 2025 Actual
- Primary completion
- Dec 23, 2026 Estimated
- Study completion
- Dec 23, 2026 Estimated
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Patient Navigation in Gynecologic Oncology: Improving Care Among Marginalized Endometrial Cancer Patients
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026