Optimizing the Care Pathways of Patients Treated for Operable Breast. (OPTIsoins01)
Optimizing the Care Pathways of Patients Treated for Operable Breast Cancer
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
-
Argenteuil, Francie, 95100
- Victor Dupouy Hospital
-
Clamart, Francie
- Antoine Béclère Hospital
-
Colombes, Francie, 92700
- Louis Mourier Hospital
-
Le Chesnay, Francie, 78150
- André Mignot Hospital - Versailles
-
Paris, Francie, 75005
- Institut Curie
-
Paris, Francie, 75018
- Bichat Beaujon University Hospital
-
Poissy, Francie, 78300
- Poissy Interegional Hospital Center
-
Pontoise, Francie, 95000
- Rene Dubos Hospital
-
Saint-Cloud, Francie, 92210
- Institut Curie - René Huguenin Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Kohorta
- Časové perspektivy: Budoucí
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Care pathways description of early breast cancer patients.
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Patient satisfaction evaluation
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Up to one year after patient registration
|
Regular practitioners questionnaires
|
Up to one year after patient registration
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Care pathways suggestion for a regional health territory.
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Roman ROUZIER, Pr, Institut Curie
- Ředitel studie: Delphine HEQUET, MD PhD, Institut Curie
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IC 2014-11
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Rakovina prsu
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital a další spolupracovníciDokončenoPrůvodce klinickou aplikací Conebeam Breast CTČína
-
Xijing HospitalAktivní, ne náborRakovina prsu | Rakovina prsu (Triple Negative Breast Cancer (TNBC))Čína
-
Shanghai Henlius BiotechZatím nenabírámeRakovina prsu (Triple Negative Breast Cancer (TNBC))Čína
-
Gangnam Severance HospitalNáborHER2 Enriched Subtype Cancer Breast, Herzuma, PAM50 StudyKorejská republika
-
BioNTech SESeventh Framework ProgrammeDokončenoRakovina prsu (Triple Negative Breast Cancer (TNBC))Švédsko, Německo
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH); Rising...NáborAnatomický karcinom prsu stadia II AJCC v8 | Anatomický karcinom prsu stadia III AJCC v8 | Rané stadium karcinomu prsu | Anatomic Stage I Breast Cancer American Joint Committee on Cancer (AJCC) v8Spojené státy
-
Emory UniversityNational Cancer Institute (NCI)StaženoPrognostický karcinom prsu stadia IV AJCC v8 | Metastatický maligní novotvar v mozku | Metastatický karcinom prsu | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
NRG OncologyNational Cancer Institute (NCI)DokončenoAnatomický karcinom prsu stadia IV AJCC v8 | Prognostický karcinom prsu stadia IV AJCC v8 | Metastatický maligní novotvar v kosti | Metastatický maligní novotvar v lymfatických uzlinách | Metastatický maligní novotvar v játrech | Metastatický karcinom prsu | Metastatický maligní novotvar v plicích | Metastatický... a další podmínkySpojené státy, Kanada, Saudská arábie, Jižní Korea
-
Jessica Mezzanotte SharpeNáborNemalobuněčný karcinom plic | Klasický Hodgkinův lymfom | Spinocelulární karcinom v ústech | Melanom (rakovina kůže) | Rakovina prsu (Triple Negative Breast Cancer (TNBC)) | Invazivní karcinom prsu | Renální buněčný karcinom (rakovina ledvin) | Rakovina konečníku s MSI-H/dMMRSpojené státy