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

12. april 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

617

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Previously untreated, operable breast cancer.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Care pathways description of early breast cancer patients.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient satisfaction evaluation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to one year after patient registration
Regular practitioners questionnaires
Up to one year after patient registration

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Care pathways suggestion for a regional health territory.
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Institut Curie

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2014

Primær færdiggørelse (Faktiske)

1. februar 2017

Studieafslutning (Faktiske)

1. april 2017

Datoer for studieregistrering

Først indsendt

6. januar 2016

Først indsendt, der opfyldte QC-kriterier

21. juni 2016

Først opslået (Skøn)

27. juni 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IC 2014-11

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

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