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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Kacee Little
- Número de teléfono: 919-984-0000
- Correo electrónico: kacee_little@med.unc.edu
Ubicaciones de estudio
-
-
North Carolina
-
Chapel Hill, North Carolina, Estados Unidos, 27599
- Reclutamiento
- University of North Carolina at Chapel Hill, Department of Radiation Oncology
-
Contacto:
- Kacee Little
- Número de teléfono: 919-974-0000
- Correo electrónico: kacee_little@med.unc.edu
-
Investigador principal:
- Lisa Spees, PhD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fidelity of the navigation intervention
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Recruitment rate
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Up to 12 months
|
Cost will be measured by multiplying time required to delivery intervention with patient navigator hourly salary. |
Up to 12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lisa Spees, PhD, UNC Lineberger Comprehensive Cancer Center
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades uterinas
- Enfermedades Genitales Femeninas
- Neoplasias Genitales Femeninas
- Neoplasias Uterinas
- Neoplasias Endometriales
Otros números de identificación del estudio
- LCCC2436
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .