Optimizing the Care Pathways of Patients Treated for Operable Breast. (OPTIsoins01)
Optimizing the Care Pathways of Patients Treated for Operable Breast Cancer
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Argenteuil, France, 95100
- Victor Dupouy Hospital
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Clamart, France
- Antoine Béclère Hospital
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Colombes, France, 92700
- Louis Mourier Hospital
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Le Chesnay, France, 78150
- André Mignot Hospital - Versailles
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Paris, France, 75005
- Institut Curie
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Paris, France, 75018
- Bichat Beaujon University Hospital
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Poissy, France, 78300
- Poissy Interegional Hospital Center
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Pontoise, France, 95000
- Rene Dubos Hospital
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Saint-Cloud, France, 92210
- Institut Curie - René Huguenin Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Care pathways description of early breast cancer patients.
Délai: 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.
Délai: Up to one year after patient registration
|
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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Patient satisfaction evaluation
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Care pathways suggestion for a regional health territory.
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Roman ROUZIER, Pr, Institut Curie
- Directeur d'études: Delphine HEQUET, MD PhD, Institut Curie
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IC 2014-11
Plan pour les données individuelles des participants (IPD)
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