Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

12 aprile 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

617

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Previously untreated, operable breast cancer.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Coorte
  • Prospettive temporali: Prospettiva

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Care pathways description of early breast cancer patients.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient satisfaction evaluation
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to one year after patient registration
Regular practitioners questionnaires
Up to one year after patient registration

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Care pathways suggestion for a regional health territory.
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Institut Curie

Investigatori

  • Direttore dello studio: Roman ROUZIER, Pr, Institut Curie
  • Direttore dello studio: Delphine HEQUET, MD PhD, Institut Curie

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 dicembre 2014

Completamento primario (Effettivo)

1 febbraio 2017

Completamento dello studio (Effettivo)

1 aprile 2017

Date di iscrizione allo studio

Primo inviato

6 gennaio 2016

Primo inviato che soddisfa i criteri di controllo qualità

21 giugno 2016

Primo Inserito (Stima)

27 giugno 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 aprile 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 aprile 2017

Ultimo verificato

1 aprile 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IC 2014-11

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Cancro al seno

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Mexico

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi