Optimizing the Care Pathways of Patients Treated for Operable Breast. (OPTIsoins01)
Optimizing the Care Pathways of Patients Treated for Operable Breast Cancer
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The treatment course of a breast cancer patient includes a hospital stay, home health care that requires outpatient services, supportive care and a follow-up course. Outpatient surgery and home hospitalization units are two innovative organizational technologies that are strongly recommended because of their putative positive medico-economic impact; however, these structures are poorly studied in terms of quality of care and patient satisfaction. Regional implementation of these innovations is heterogeneous, thus allowing a comparative study.
This prospective, multicenter, observational study aims to explore a comprehensive approach to the care of early breast cancer patients in a regional health territory (including 1.5 million women and characterized by a breast cancer incidence and mortality higher than national ranges), incorporating all healthcare actors inside and outside the hospital.
This study will be conducted in academic centers, general hospitals and private centers. In the different participating centers, the implemented care steps are different and may include outpatient surgery, home hospitalization, a one-stop breast clinic visit, care by an oncology pivot nurse and/or screening for supportive care. Outpatient surgery and home hospitalization in particular are two health technologies that are validated by the French National Authority for Health but used differently in different centers.
The primary objective is to examine the economic and financial measurements of the different care pathways of early breast cancer patients to compare the economic burden of outpatient surgery and home hospitalization with the conventional care pathway.
The secondary objectives are:
Assessing patient satisfaction and needs for supportive care. Evaluating the structures and organizations. Evaluating the tool exchanges between the actors over the treatment course.
All parameters related to the patient and to disease characteristics, determinants and management characteristics within and outside the center within one year will be collected and centralized in the study database. The patients' course of care will be divided into five stages: preadmission, hospitalization, the postoperative period (+ 1 month), adjuvant treatments and one-year follow-up. Care pathways will be identified, described and analyzed to meet the primary objective and the secondary objectives.
After analyzing these care pathways, we will propose solutions for optimizing hospital and nonhospital care, thereby building efficient connections among the hospital, home health care, district nurse networks, medical and social sectors, and occupational reintegration.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Argenteuil, Francia, 95100
- Victor Dupouy Hospital
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Clamart, Francia
- Antoine Béclère Hospital
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Colombes, Francia, 92700
- Louis Mourier Hospital
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Le Chesnay, Francia, 78150
- André Mignot Hospital - Versailles
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Paris, Francia, 75005
- Institut Curie
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Paris, Francia, 75018
- Bichat Beaujon University Hospital
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Poissy, Francia, 78300
- Poissy Interegional Hospital Center
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Pontoise, Francia, 95000
- Rene Dubos Hospital
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Saint-Cloud, Francia, 92210
- Institut Curie - René Huguenin Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Signed written informed consent.
- Patients aged ≥18 years.
- Previously untreated, operable breast cancer
- Affiliation with the social security system (or a similar coverage)
- Patient living in one of these french department : "Hauts-de-Seine (92)", "les Yvelines (78)", or "le Val d'Oise (95)".
- Female gender.
Exclusion Criteria:
- Previous history of breast cancer.
- Metastatic, locally advanced, or inflammatory breast cancer, as defined by the AJCC (American Joint Committee on Cancer, 7th Edition).
- Any prior treatment for primary breast cancer.
- Patient with any psychological, sociological or geographical condition potentially hampering compliance with the study follow-up schedule.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Care pathways description of early breast cancer patients.
Periodo de tiempo: Up to one year after patient registration
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Care pathways will be characterized by the sequence of different care steps.
Care steps may include : outpatient surgery, home hospitalization, a one-stop breast clinic visit, care by an oncology pivot nurse and/or screening for supportive care.
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Up to one year after patient registration
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Overall cost measurements of the different care pathways.
Periodo de tiempo: Up to one year after patient registration
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Evaluating the overall costs of the pathway care (health care and supportive care consumption) at one year for the different perspectives.
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Up to one year after patient registration
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Overall cost measurements of the different care pathways for health insurance
Periodo de tiempo: Up to one year after patient registration
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Evaluating the indirect costs of health insurance
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Up to one year after patient registration
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Overall cost measurements of the different care pathways for the patient
Periodo de tiempo: Up to one year after patient registration
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Evaluating the out-of-pocket health expenses for breast cancer during the first year post diagnosis (direct and indirect costs).
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Up to one year after patient registration
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient satisfaction evaluation
Periodo de tiempo: Up to one year after patient registration.
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Patient satisfaction will be assessed at different time points using the OUT-PATSAT35 questionnaire validated in French.
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Up to one year after patient registration.
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Supportive care needs assessement
Periodo de tiempo: Up to one year after patient registration
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The patient's needs for supportive care will be assessed using the Supportive Care Needs Survey - Breast Cancer module (SCNS-BR8) validated in French.
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Up to one year after patient registration
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Supportive care needs assessement
Periodo de tiempo: Up to one year after patient registration
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The patient's needs for supportive care will be assessed using the Supportive Care Needs Survey Short Form (SCNS-SF34) validated in French.
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Up to one year after patient registration
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Breast cancer impact on patient's professional activity
Periodo de tiempo: Up to one year after patient registration.
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Evaluating patient return to work : Existence of an occupational reintegration or not.
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Up to one year after patient registration.
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Breast cancer impact on patient's professional activity
Periodo de tiempo: Up to one year after patient registration.
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Evaluating patient return to work : Date of return to work
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Up to one year after patient registration.
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Breast cancer impact on patient's professional activity
Periodo de tiempo: Up to one year after patient registration.
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Evaluating patient return to work : Organization of working time description
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Up to one year after patient registration.
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Breast cancer impact on patient's professional activity
Periodo de tiempo: Up to one year after patient registration.
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Evaluating patient return to work : Number of days out of work
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Up to one year after patient registration.
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Structures and organizations interactions description
Periodo de tiempo: Up to one year after patient registration
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Identification of health care actors inside and outside the hospital
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Up to one year after patient registration
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Structures and organizations interactions description
Periodo de tiempo: Up to one year after patient registration
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identification of the interactions between the organizations (e.g., identification, shared tools, resource sharing and nurse training).
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Up to one year after patient registration
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Structures and organizations interactions description
Periodo de tiempo: Up to one year after patient registration
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Regular practitioners questionnaires
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Up to one year after patient registration
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Care pathways suggestion for a regional health territory.
Periodo de tiempo: Through study completion (within one year after the last patient follow-up)
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After analyzing these care pathways, we will propose solutions for optimizing hospital and nonhospital care, thereby building efficient connections among the hospital, home health care, district nurse networks, medical and social sectors, and occupational reintegration.
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Through study completion (within one year after the last patient follow-up)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Roman ROUZIER, Pr, Institut Curie
- Director de estudio: Delphine HEQUET, MD PhD, Institut Curie
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
Otros números de identificación del estudio
- IC 2014-11
Plan de datos de participantes individuales (IPD)
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