Psychological Services Integration in Gynecological Oncology Clinics
30 de mayo de 2019 actualizado por: Washington University School of Medicine
Implementation and Evaluation of Psychological Services Integration in Gynecological Oncology Clinics
The purpose of this study is to understand the feasibility and impact of integrated psychological care in outpatient gynecologic oncology clinics with the goal of creating a new standard of care.
The investigators propose an intervention study comparing patient-centered outcomes (assessed by surveys) between women who receive usual care versus integrated psychological care.
The investigators' objectives are to learn about the process of integration of psychological care directly into outpatient gynecologic oncology clinics and the impact of such integration on patients' well-being, presentation of symptoms, psychological functioning, coping mechanisms, awareness of support services offered, and perception of quality of care.
As this is a feasibility study, aims are focused on assessing patient willingness for psychological intervention in the medical office, provider willingness to have psychologist present in clinic, and impact of psychological intervention.
With such data to warrant further integration and time of psychologists in medical clinics, next steps for immediate and long-term projects may include focus on high risk populations, specific disease sites, additional provider clinics, more psychologist time spent in gynecological oncology clinics, and effectiveness of interventions with higher power.
The investigators hope the results will serve as preliminary data for an integrated psychosocial care model that can be implemented in other oncology clinics.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
101
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Aged 18 years or older
- Scheduled for an appointment in a gynecologic oncology clinic at the Siteman Cancer Center at the Center for Advanced Medicine or the Women's Tumor Clinic at the Center for Outpatient Health at Barnes-Jewish Hospital
- Patients may or may not have a cancer diagnosis.
- All gynecologic cancer types, histologic grades, primary or recurrent disease.
- Patients actively undergoing treatment or close observation
- Pregnant or lactating patients
- Able to speak and read English
- Able to consent
Inclusion criteria (correlative studies only) -Patients who are undergoing pre-operative work-up for evaluation of an adnexal mass by a Washington University gynecologic oncologist.
Exclusion Criteria:
-Impaired by a psychiatric or cognitive disorder that limits their ability to give consent or communicate with their medical providers about symptoms (as determined by the patient's medical team)
Exclusion criteria (correlative studies only)
- Neoadjuvant chemotherapy
- Treatment within the past month with antidepressant medications that affect serotonin physiology
- Specific histology: low malignant potential tumors, non-epithelial cancer histology.
- Previous cancer diagnosis within the past five years or recurrent cancer
- Regular steroid use in the last month
- Presence of comorbidities with known effects on the immune system (e.g., systemic lupus erythematosus, multiple sclerosis, and rheumatoid arthritis), congestive heart failure, pregnancy, or stroke within the past six months
- Major surgery in the past month.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Arm 1: Usual Care
-No psychosocial care in clinic
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Experimental: Arm 2: Integrated Care
-Those who receive integrated care will receive a one-page care plan completed by Dr. Vanderlan including their scores from screening questionnaires , recommendations for coping strategies and available supportive resources.
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Additional possible strategies used may include supportive or validating interventions, increasing/introducing/reinforcing coping strategies, psychoeducation; distress tolerance skills; brief cognitive behavioral therapy; cognitive restructuring; activity scheduling; acceptance; and relaxation/mindfulness.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility of integrating psychosocial care by a trained psychologist into gynecologic cancer outpatient clinics as measured by patient enrollment
Periodo de tiempo: Completion of patient enrollment (approximately 12 months)
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-Willingness to participate with integrated care as quantified by proportion of enrolled patients from the number of approached eligible patients
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Completion of patient enrollment (approximately 12 months)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Provider willingness to have a psychologist present
Periodo de tiempo: 6 months after start of study enrollment
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-5 item survey about willingness to have psychologist present in clinic
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6 months after start of study enrollment
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Differences in clinic visit duration with and without a psychologist present
Periodo de tiempo: Day 1
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-Clinic visit duration is defined as the time from check-in to patient discharge
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Day 1
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Difference in psychological correlates of daily functioning as measured by patient distress between women who receive usual care versus integrated psychological care
Periodo de tiempo: Enrollment, 3 months after enrollment, and 6 months after enrollment
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Enrollment, 3 months after enrollment, and 6 months after enrollment
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Difference in psychological correlates of daily functioning as measured by patient depression between women who receive usual care versus integrated psychological care
Periodo de tiempo: Enrollment, 3 months after enrollment, and 6 months after enrollment
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Enrollment, 3 months after enrollment, and 6 months after enrollment
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Difference in psychological correlates of daily functioning as measured by patient anxiety between women who receive usual care versus integrated psychological care
Periodo de tiempo: Enrollment, 3 months after enrollment, and 6 months after enrollment
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Enrollment, 3 months after enrollment, and 6 months after enrollment
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Difference in psychological correlates of daily functioning as measured by patient quality of life between women who receive usual care versus integrated psychological care
Periodo de tiempo: Enrollment, 3 months after enrollment, and 6 months after enrollment
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Enrollment, 3 months after enrollment, and 6 months after enrollment
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Difference in psychological correlates of daily functioning as measured by patient coping mechanisms between women who receive usual care versus integrated psychological care
Periodo de tiempo: Enrollment, 3 months after enrollment, and 6 months after enrollment
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Enrollment, 3 months after enrollment, and 6 months after enrollment
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Difference in psychological correlates of perception of psychological care as measured by patient perception of Siteman Cancer Center being highly focused on their wellbeing between women who receive usual care versus integrated psychological care
Periodo de tiempo: Enrollment, 3 months after enrollment, and 6 months after enrollment
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Enrollment, 3 months after enrollment, and 6 months after enrollment
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Difference in psychological correlates of awareness of psychological care as measured by awareness of support services offered between women who receive usual care versus integrated psychological care
Periodo de tiempo: Enrollment, 3 months after enrollment, and 6 months after enrollment
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Enrollment, 3 months after enrollment, and 6 months after enrollment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jessica Vanderlan, Ph.D., Washington University School of Medicine
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
8 de mayo de 2018
Finalización primaria (Actual)
29 de agosto de 2018
Finalización del estudio (Actual)
26 de marzo de 2019
Fechas de registro del estudio
Enviado por primera vez
21 de marzo de 2018
Primero enviado que cumplió con los criterios de control de calidad
21 de marzo de 2018
Publicado por primera vez (Actual)
29 de marzo de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de junio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
30 de mayo de 2019
Última verificación
1 de mayo de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 201711117
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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