Optimizing the Care Pathways of Patients Treated for Operable Breast. (OPTIsoins01)

Optimizing the Care Pathways of Patients Treated for Operable Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Surgery

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 Type: Observational
• Enrollment (Actual): 617

Contacts and Locations

Study Locations

• France
  • Argenteuil, France, 95100
    • Victor Dupouy Hospital
  • Clamart, France
    • Antoine Beclère Hospital
  • Colombes, France, 92700
    • Louis Mourier Hospital
  • Le Chesnay, France, 78150
    • André Mignot Hospital - Versailles
  • Paris, France, 75005
    • Institut Curie
  • Paris, France, 75018
    • Bichat Beaujon University Hospital
  • Poissy, France, 78300
    • Poissy Interegional Hospital Center
  • Pontoise, France, 95000
    • Rene Dubos Hospital
  • Saint-Cloud, France, 92210
    • Institut Curie - René Huguenin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Previously untreated, operable breast cancer.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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
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.
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.
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.
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.
Structures and organizations interactions description	Identification of health care actors inside and outside the hospital	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).	Up to one year after patient registration
Structures and organizations interactions description	Regular practitioners questionnaires	Up to one year after patient registration

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Study Director: Roman ROUZIER, Pr, Institut Curie; Study Director: Delphine HEQUET, MD PhD, Institut Curie

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: January 6, 2016
• First Submitted That Met QC Criteria: June 21, 2016
• First Posted (Estimate): June 27, 2016

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Surgery; Quality of life; Breast cancer; Economic evaluation; Care pathway
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IC 2014-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No