Optimizing the Care Pathways of Patients Treated for Operable Breast.

Breast Cancer Clinical Trial

— OPTIsoins01  

Official title:

Optimizing the Care Pathways of Patients Treated for Operable Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813317
• Other study ID #: IC 2014-11
• Status: Completed
• Phase: N/A
• First received: January 6, 2016
• Last updated: April 12, 2017
• Start date: December 2014
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 617
• Est. completion date: April 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Surgery

Locations

Country	Name	City	State
France	Victor Dupouy Hospital	Argenteuil
France	Antoine Béclère Hospital	Clamart
France	Louis Mourier Hospital	Colombes
France	André Mignot Hospital - Versailles	Le Chesnay
France	Bichat Beaujon University Hospital	Paris
France	Institut Curie	Paris
France	Poissy Interegional Hospital Center	Poissy
France	René Dubos Hospital	Pontoise
France	Institut Curie - René Huguenin Hospital	Saint-Cloud

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Care pathways suggestion for a regional health territory.	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.	Through study completion (within one year after the last patient follow-up)
Primary	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.	Up to one year after patient registration
Primary	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.	Up to one year after patient registration
Primary	Overall cost measurements of the different care pathways for health insurance	Evaluating the indirect costs of health insurance	Up to one year after patient registration
Primary	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).	Up to one year after patient registration
Secondary	Patient satisfaction evaluation	Patient satisfaction will be assessed at different time points using the OUT-PATSAT35 questionnaire validated in French.	Up to one year after patient registration.
Secondary	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.	Up to one year after patient registration
Secondary	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.	Up to one year after patient registration
Secondary	Breast cancer impact on patient's professional activity	Evaluating patient return to work : Existence of an occupational reintegration or not.	Up to one year after patient registration.
Secondary	Breast cancer impact on patient's professional activity	Evaluating patient return to work : Date of return to work	Up to one year after patient registration.
Secondary	Breast cancer impact on patient's professional activity	Evaluating patient return to work : Organization of working time description	Up to one year after patient registration.
Secondary	Breast cancer impact on patient's professional activity	Evaluating patient return to work : Number of days out of work	Up to one year after patient registration.
Secondary	Structures and organizations interactions description	Identification of health care actors inside and outside the hospital	Up to one year after patient registration
Secondary	Structures and organizations interactions description	identification of the interactions between the organizations (e.g., identification, shared tools, resource sharing and nurse training).	Up to one year after patient registration
Secondary	Structures and organizations interactions description	Regular practitioners questionnaires	Up to one year after patient registration