Overview

This trial is active, not recruiting.

Conditions breast cancer, surgery
Sponsor Institut Curie
Start date December 2014
End date February 2017
Trial size 617 participants
Trial identifier NCT02813317, IC 2014-11

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Care pathways description of early breast cancer patients.
time frame: Up to one year after patient registration
Overall cost measurements of the different care pathways.
time frame: Up to one year after patient registration
Overall cost measurements of the different care pathways for health insurance
time frame: Up to one year after patient registration
Overall cost measurements of the different care pathways for the patient
time frame: Up to one year after patient registration

Secondary Outcomes

Measure
Patient satisfaction evaluation
time frame: Up to one year after patient registration.
Supportive care needs assessement
time frame: Up to one year after patient registration
Supportive care needs assessement
time frame: Up to one year after patient registration
Breast cancer impact on patient's professional activity
time frame: Up to one year after patient registration.
Breast cancer impact on patient's professional activity
time frame: Up to one year after patient registration.
Breast cancer impact on patient's professional activity
time frame: Up to one year after patient registration.
Breast cancer impact on patient's professional activity
time frame: Up to one year after patient registration.
Structures and organizations interactions description
time frame: Up to one year after patient registration
Structures and organizations interactions description
time frame: Up to one year after patient registration
Structures and organizations interactions description
time frame: Up to one year after patient registration

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: 1. Signed written informed consent. 2. Patients aged ≥18 years. 3. Previously untreated, operable breast cancer 4. Affiliation with the social security system (or a similar coverage) 5. Patient living in one of these french department : "Hauts-de-Seine (92)", "les Yvelines (78)", or "le Val d'Oise (95)". 6. Female gender. Exclusion Criteria: 1. Previous history of breast cancer. 2. Metastatic, locally advanced, or inflammatory breast cancer, as defined by the AJCC (American Joint Committee on Cancer, 7th Edition). 3. Any prior treatment for primary breast cancer. 4. Patient with any psychological, sociological or geographical condition potentially hampering compliance with the study follow-up schedule.

Additional Information

Official title Optimizing the Care Pathways of Patients Treated for Operable Breast Cancer
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Institut Curie.