Improving Rural Endometrial Cancer Care
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Kacee Little
- Numéro de téléphone: 919-984-0000
- E-mail: kacee_little@med.unc.edu
Lieux d'étude
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599
- Recrutement
- University of North Carolina at Chapel Hill, Department of Radiation Oncology
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Contact:
- Kacee Little
- Numéro de téléphone: 919-974-0000
- E-mail: kacee_little@med.unc.edu
-
Chercheur principal:
- Lisa Spees, PhD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Rural cancer patients
Endometrial cancer patients located over 25 miles away from treatment center |
patients begin the navigation program, which includes three structured assessments: a pre-consult assessment, a pre-treatment assessment, and an active-treatment assessment. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Fidelity of the navigation intervention
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Recruitment rate
Délai: 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
Délai: 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
Délai: 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
Délai: Up to 12 months
|
Cost will be measured by multiplying time required to delivery intervention with patient navigator hourly salary. |
Up to 12 months
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Lisa Spees, PhD, UNC Lineberger Comprehensive Cancer Center
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LCCC2436
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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