Skip to main content
OpenTrials
Completed

NCT Number: NCT02813317

Optimizing the Care Pathways of Patients Treated for Operable Breast.

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Victor Dupouy Hospital, Argenteuil, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed written informed consent.
  • Patients aged ≥18 years.
  • Previously untreated, operable breast cancer
  • Affiliation with the social security system (or a similar coverage)
  • Patient living in one of these french department : "Hauts-de-Seine (92)", "les Yvelines (78)", or "le Val d'Oise (95)".
  • Female gender.

Exclusion criteria

  • Previous history of breast cancer.
  • Metastatic, locally advanced, or inflammatory breast cancer, as defined by the AJCC (American Joint Committee on Cancer, 7th Edition).
  • Any prior treatment for primary breast cancer.
  • Patient with any psychological, sociological or geographical condition potentially hampering compliance with the study follow-up schedule.

Treatment and study plan

Primary outcomes

  1. Care pathways description of early breast cancer patients.

    Time frame: 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.

  2. Overall cost measurements of the different care pathways.

    Time frame: 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.

  3. Overall cost measurements of the different care pathways for health insurance

    Time frame: Up to one year after patient registration

    Evaluating the indirect costs of health insurance

  4. Overall cost measurements of the different care pathways for the patient

    Time frame: 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).

Secondary outcomes

  1. Patient satisfaction evaluation

    Time frame: Up to one year after patient registration.

    Patient satisfaction will be assessed at different time points using the OUT-PATSAT35 questionnaire validated in French.

  2. Supportive care needs assessement

    Time frame: Up to one year after patient registration

    The patient's needs for supportive care will be assessed using the Supportive Care Needs Survey - Breast Cancer module (SCNS-BR8) validated in French.

  3. Supportive care needs assessement

    Time frame: 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.

  4. Breast cancer impact on patient's professional activity

    Time frame: Up to one year after patient registration.

    Evaluating patient return to work : Existence of an occupational reintegration or not.

  5. Breast cancer impact on patient's professional activity

    Time frame: Up to one year after patient registration.

    Evaluating patient return to work : Date of return to work

  6. Breast cancer impact on patient's professional activity

    Time frame: Up to one year after patient registration.

    Evaluating patient return to work : Organization of working time description

  7. Breast cancer impact on patient's professional activity

    Time frame: Up to one year after patient registration.

    Evaluating patient return to work : Number of days out of work

  8. Structures and organizations interactions description

    Time frame: Up to one year after patient registration

    Identification of health care actors inside and outside the hospital

  9. Structures and organizations interactions description

    Time frame: Up to one year after patient registration

    identification of the interactions between the organizations (e.g., identification, shared tools, resource sharing and nurse training).

  10. Structures and organizations interactions description

    Time frame: Up to one year after patient registration

    Regular practitioners questionnaires

Other outcomes

  1. Care pathways suggestion for a regional health territory.

    Time frame: Through study completion (within one year after the last patient follow-up)

    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.

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study title

Optimizing the Care Pathways of Patients Treated for Operable Breast Cancer

Acronym: OPTIsoins01

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 27, 2016
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.