Optimizing the Care Pathways of Patients Treated for Operable Breast. (OPTIsoins01)
Optimizing the Care Pathways of Patients Treated for Operable Breast Cancer
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Argenteuil, França, 95100
- Victor Dupouy Hospital
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Clamart, França
- Antoine Béclère Hospital
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Colombes, França, 92700
- Louis Mourier Hospital
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Le Chesnay, França, 78150
- André Mignot Hospital - Versailles
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Paris, França, 75005
- Institut Curie
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Paris, França, 75018
- Bichat Beaujon University Hospital
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Poissy, França, 78300
- Poissy Interegional Hospital Center
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Pontoise, França, 95000
- Rene Dubos Hospital
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Saint-Cloud, França, 92210
- Institut Curie - René Huguenin Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Care pathways description of early breast cancer patients.
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Patient satisfaction evaluation
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Care pathways suggestion for a regional health territory.
Prazo: 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
- Diretor de estudo: Roman ROUZIER, Pr, Institut Curie
- Diretor de estudo: Delphine HEQUET, MD PhD, Institut Curie
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IC 2014-11
Plano para dados de participantes individuais (IPD)
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