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.
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.
Study Type
OBSERVATIONAL
Enrollment
617
Victor Dupouy Hospital
Argenteuil, France
Antoine Béclère Hospital
Clamart, France
Louis Mourier Hospital
Colombes, France
André Mignot Hospital - Versailles
Le Chesnay, France
Care pathways description of early breast cancer patients.
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.
Time frame: Up to one year after patient registration
Overall cost measurements of the different care pathways.
Evaluating the overall costs of the pathway care (health care and supportive care consumption) at one year for the different perspectives.
Time frame: Up to one year after patient registration
Overall cost measurements of the different care pathways for health insurance
Evaluating the indirect costs of health insurance
Time frame: Up to one year after patient registration
Overall cost measurements of the different care pathways for the patient
Evaluating the out-of-pocket health expenses for breast cancer during the first year post diagnosis (direct and indirect costs).
Time frame: Up to one year after patient registration
Patient satisfaction evaluation
Patient satisfaction will be assessed at different time points using the OUT-PATSAT35 questionnaire validated in French.
Time frame: Up to one year after patient registration.
Supportive care needs assessement
The patient's needs for supportive care will be assessed using the Supportive Care Needs Survey - Breast Cancer module (SCNS-BR8) validated in French.
Time frame: Up to one year after patient registration
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Institut Curie
Paris, France
Bichat Beaujon University Hospital
Paris, France
Poissy Interegional Hospital Center
Poissy, France
René Dubos Hospital
Pontoise, France
Institut Curie - René Huguenin Hospital
Saint-Cloud, France
Supportive care needs assessement
The patient's needs for supportive care will be assessed using the Supportive Care Needs Survey Short Form (SCNS-SF34) validated in French.
Time frame: Up to one year after patient registration
Breast cancer impact on patient's professional activity
Evaluating patient return to work : Existence of an occupational reintegration or not.
Time frame: Up to one year after patient registration.
Breast cancer impact on patient's professional activity
Evaluating patient return to work : Date of return to work
Time frame: Up to one year after patient registration.
Breast cancer impact on patient's professional activity
Evaluating patient return to work : Organization of working time description
Time frame: Up to one year after patient registration.
Breast cancer impact on patient's professional activity
Evaluating patient return to work : Number of days out of work
Time frame: Up to one year after patient registration.
Structures and organizations interactions description
Identification of health care actors inside and outside the hospital
Time frame: Up to one year after patient registration
Structures and organizations interactions description
identification of the interactions between the organizations (e.g., identification, shared tools, resource sharing and nurse training).
Time frame: Up to one year after patient registration
Structures and organizations interactions description
Regular practitioners questionnaires
Time frame: Up to one year after patient registration