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Improving Rural Endometrial Cancer Care

4 november 2026 uppdaterad av: UNC Lineberger Comprehensive Cancer Center

Patient Navigation in Gynecologic Oncology: Improving Care Among Marginalized Endometrial Cancer Patients

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

50

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • North Carolina
      • Chapel Hill, North Carolina, Förenta staterna, 27599
        • Rekrytering
        • University of North Carolina at Chapel Hill, Department of Radiation Oncology
        • Kontakt:
        • Huvudutredare:
          • Lisa Spees, PhD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Rural cancer patients

Endometrial cancer patients located over 25 miles away from treatment center
Beteende: The patient-navigation program

patients begin the navigation program, which includes three structured assessments: a pre-consult assessment, a pre-treatment assessment, and an active-treatment assessment.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Fidelity of the navigation intervention
Tidsram: 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.
Up to 12 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Recruitment rate
Tidsram: 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.
Baseline
Retention rate
Tidsram: 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.
Up to 12 months
Acceptability rate
Tidsram: 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.
Up to 12 months
Cost
Tidsram: Up to 12 months

Cost will be measured by multiplying time required to delivery intervention with patient navigator hourly salary.
Up to 12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Utredare

  • Huvudutredare: Lisa Spees, PhD, UNC Lineberger Comprehensive Cancer Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

9 maj 2025

Primärt slutförande (Beräknad)

23 december 2026

Avslutad studie (Beräknad)

23 december 2026

Studieregistreringsdatum

Först inskickad

4 november 2026

Först inskickad som uppfyllde QC-kriterierna

4 november 2026

Första postat (Faktisk)

10 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • LCCC2436

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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