Clinical trial NCT02813317: Optimizing the Care Pathways of Patients Treated for Operable Breast.
Official title: Optimizing the Care Pathways of Patients Treated for Operable Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Surgery
Keywords: Surgery
Breast cancer
Quality of life
Care pathway
Economic evaluation
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 617
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previously untreated, operable breast cancer.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Care pathways description of early breast cancer patients.
timeFrame: Up to one year after patient registration
measure: Overall cost measurements of the different care pathways.
timeFrame: Up to one year after patient registration
measure: Overall cost measurements of the different care pathways for health insurance
timeFrame: Up to one year after patient registration
measure: Overall cost measurements of the different care pathways for the patient
timeFrame: Up to one year after patient registration
Secondary outcomes:
measure: Patient satisfaction evaluation
timeFrame: Up to one year after patient registration.
measure: Supportive care needs assessement
timeFrame: Up to one year after patient registration
measure: Supportive care needs assessement
timeFrame: Up to one year after patient registration
measure: Breast cancer impact on patient's professional activity
timeFrame: Up to one year after patient registration.
measure: Breast cancer impact on patient's professional activity
timeFrame: Up to one year after patient registration.
measure: Breast cancer impact on patient's professional activity
timeFrame: Up to one year after patient registration.
measure: Breast cancer impact on patient's professional activity
timeFrame: Up to one year after patient registration.
measure: Structures and organizations interactions description
timeFrame: Up to one year after patient registration
measure: Structures and organizations interactions description
timeFrame: Up to one year after patient registration
measure: Structures and organizations interactions description
timeFrame: Up to one year after patient registration
Other outcomes:
measure: Care pathways suggestion for a regional health territory.
timeFrame: Through study completion (within one year after the last patient follow-up)
Locations:
city: Argenteuil
country: France
facility: Victor Dupouy Hospital
city: Clamart
country: France
facility: Antoine Béclère Hospital
city: Colombes
country: France
facility: Louis Mourier Hospital
city: Le Chesnay
country: France
facility: André Mignot Hospital - Versailles
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Bichat Beaujon University Hospital
city: Poissy
country: France
facility: Poissy Interegional Hospital Center
city: Pontoise
country: France
facility: René Dubos Hospital
city: Saint-Cloud
country: France
facility: Institut Curie - René Huguenin Hospital
Study officials:
affiliation: Institut Curie
name: Roman ROUZIER, Pr
role: STUDY_DIRECTOR
affiliation: Institut Curie
name: Delphine HEQUET, MD PhD
role: STUDY_DIRECTOR
References:
citation: Arfi A, Baffert S, Soilly AL, Huchon C, Reyal F, Asselain B, Neffati S, Rouzier R, Hequet D. Determinants of return at work of breast cancer patients: results from the OPTISOINS01 French prospective study. BMJ Open. 2018 May 18;8(5):e020276. doi: 10.1136/bmjopen-2017-020276.