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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Kacee Little
- Número de telefone: 919-984-0000
- E-mail: kacee_little@med.unc.edu
Locais de estudo
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- Recrutamento
- University of North Carolina at Chapel Hill, Department of Radiation Oncology
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Contato:
- Kacee Little
- Número de telefone: 919-974-0000
- E-mail: kacee_little@med.unc.edu
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Investigador principal:
- Lisa Spees, PhD
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Fidelity of the navigation intervention
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Recruitment rate
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- LCCC2436
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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