Optimizing the Care Pathways of Patients Treated for Operable Breast.

Completed

• Conditions: Breast Cancer; Surgery

• Registration Number: NCT02813317
• Lead Sponsor: Institut Curie

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-06-21
• Study First Posted: 2016-06-27
• Primary Completion: 2017-02
• Status Verified: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 617

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall cost measurements of the different care pathways.	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.
Overall cost measurements of the different care pathways for the patient	Up to one year after patient registration	Evaluating the out-of-pocket health expenses for breast cancer during the first year post diagnosis (direct and indirect costs).
Care pathways description of early breast cancer patients.	Up to one year after patient registration	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.
Overall cost measurements of the different care pathways for health insurance	Up to one year after patient registration	Evaluating the indirect costs of health insurance

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction evaluation	Up to one year after patient registration.	Patient satisfaction will be assessed at different time points using the OUT-PATSAT35 questionnaire validated in French.
Structures and organizations interactions description	Up to one year after patient registration	Regular practitioners questionnaires
Supportive care needs assessement	Up to one year after patient registration	The patient's needs for supportive care will be assessed using the Supportive Care Needs Survey Short Form (SCNS-SF34) validated in French.
Breast cancer impact on patient's professional activity	Up to one year after patient registration.	Evaluating patient return to work : Number of days out of work

Trial Locations

Locations (9)

René Dubos Hospital; 🇫🇷 Pontoise, France

Institut Curie - René Huguenin Hospital; 🇫🇷 Saint-Cloud, France

Victor Dupouy Hospital; 🇫🇷 Argenteuil, France

André Mignot Hospital - Versailles; 🇫🇷 Le Chesnay, France

Institut Curie; 🇫🇷 Paris, France

Poissy Interegional Hospital Center; 🇫🇷 Poissy, France

Antoine Béclère Hospital; 🇫🇷 Clamart, France

Louis Mourier Hospital; 🇫🇷 Colombes, France

Bichat Beaujon University Hospital; 🇫🇷 Paris, France