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

12. April 2017 aktualisiert von: Institut Curie

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

617

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Previously untreated, operable breast cancer.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: Kohorte
  • Zeitperspektiven: Interessent

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Care pathways description of early breast cancer patients.
Zeitfenster: 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.
Up to one year after patient registration
Overall cost measurements of the different care pathways.
Zeitfenster: 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.
Up to one year after patient registration
Overall cost measurements of the different care pathways for health insurance
Zeitfenster: Up to one year after patient registration
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
Zeitfenster: 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).
Up to one year after patient registration

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Patient satisfaction evaluation
Zeitfenster: Up to one year after patient registration.
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
Zeitfenster: 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.
Up to one year after patient registration
Supportive care needs assessement
Zeitfenster: 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.
Up to one year after patient registration
Breast cancer impact on patient's professional activity
Zeitfenster: Up to one year after patient registration.
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
Zeitfenster: Up to one year after patient registration.
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
Zeitfenster: Up to one year after patient registration.
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
Zeitfenster: Up to one year after patient registration.
Evaluating patient return to work : Number of days out of work
Up to one year after patient registration.
Structures and organizations interactions description
Zeitfenster: Up to one year after patient registration
Identification of health care actors inside and outside the hospital
Up to one year after patient registration
Structures and organizations interactions description
Zeitfenster: Up to one year after patient registration
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
Zeitfenster: Up to one year after patient registration
Regular practitioners questionnaires
Up to one year after patient registration

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Care pathways suggestion for a regional health territory.
Zeitfenster: 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.
Through study completion (within one year after the last patient follow-up)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Institut Curie

Ermittler

  • Studienleiter: Roman ROUZIER, Pr, Institut Curie
  • Studienleiter: Delphine HEQUET, MD PhD, Institut Curie

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Dezember 2014

Primärer Abschluss (Tatsächlich)

1. Februar 2017

Studienabschluss (Tatsächlich)

1. April 2017

Studienanmeldedaten

Zuerst eingereicht

6. Januar 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Juni 2016

Zuerst gepostet (Schätzen)

27. Juni 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. April 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. April 2017

Zuletzt verifiziert

1. April 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IC 2014-11

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

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