- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04016038
Psychosocial Approach and Sedation Practices
Sedation in Palliative Care Management Context for Cancer Patients
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Scientific Background: Physicians have an ethical obligation to relieve the refractory symptoms of patients with advanced cancer. In some situations, in the face of physical symptoms and psycho-existential distress, usual treatment is not effective and palliative sedation (PS) is one of the only acceptable options. The carers, but also the relatives of the patient, are particularly involved in the process of decision-making, information and management of sedation. Despite the interest of MS practice and its impact on different levels (relational, emotional, professional, ethical), and contrary to the important development of international studies in this field, there is a lack of research in France.
Objectives of the project and a brief description of the methods: This study aims to explore in depth the representations and emotional impact of MS on carers (doctors and nurses) and relatives of cancer patients. It also aims to describe their collaboration modalities, roles and responsibilities during the decision-making process, implementation and "control" of MS. The project is a multi-center psychosocial study (home, hospitals and palliative care unit) that will take the form of a comprehensive qualitative study, both prospective (participant observation) and retrospective (interview), of patients with and without cancer, for which MS has been administered.
Expected Outcomes: The expected results are the production of original knowledge about the practice of MS in different clinical settings (hospital, home), a better understanding of the psychosocial determinants of palliative sedation decision-making, an update of knowledge transferable to develop palliative care programs that integrate the experiential, emotional, and contextual dimensions of palliative sedation, a better understanding of the communication skills needed to cope with this practice, and an awareness of health care teams and advocates. public health on this subject.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
-
Marseille, Frankrike, 13354
- Rekrytering
- Assistance Publique Hopitaux de Marseille
-
Marseille, Frankrike, 13354
- Har inte rekryterat ännu
- Assistance des Hôpitaux de Marseille
-
Kontakt:
- Patrick Sudour
- Telefonnummer: 04 91 38 29 03
- E-post: promotion.interne@ap-hm.fr
-
Kontakt:
- Lionel Dany
- Telefonnummer: 06.63.42.41.04
- E-post: Lionel.Dany@univ-amu.fr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Men and women
- Anyone from the team during the observation period
- Having accepted the presence of the observer
- Aged over 18
Exclusion Criteria:
- Members of the health care team not present during the observation period
- Member of the team refusing the presence of the observer
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
QualiPas Observational
Prospective qualitative study through a participant observation procedure with 8 care teams practicing within Palliative Care Units, Palliative Care Mobile Team or Territorial Palliative Care Team.
|
The design of this project is based partly on the UNBIASED international study and is based on an in-depth case study in a prospective and retrospective dimension of deceased cancer patients for whom sedation has been established, and this, during a given period in different care settings: home, care center, hospital and palliative care unit.
|
QualiPas clinical interview
Qualitative study retrospective research interviews with the doctor and another carer involved in the care of the patient, and close relatives of patients who had sedated before their death.
The interviews will be based on 50 cases of patients who have been sedated.
|
The design of this project is based partly on the UNBIASED international study and is based on an in-depth case study in a prospective and retrospective dimension of deceased cancer patients for whom sedation has been established, and this, during a given period in different care settings: home, care center, hospital and palliative care unit.
|
QualiPas Focus
Qualitative study by group focus group interviews with clinical teams participating in the project.
|
The design of this project is based partly on the UNBIASED international study and is based on an in-depth case study in a prospective and retrospective dimension of deceased cancer patients for whom sedation has been established, and this, during a given period in different care settings: home, care center, hospital and palliative care unit.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Assessing the quality of life
Tidsram: 36 months
|
Quality of Life Questionnaire
|
36 months
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2018-64
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Slutstadiet cancer
-
Tanta UniversityRekryteringEnd-tidal koldioxid | End-tidal Sevofluran | Minsta alveolära koncentrationEgypten
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalAvslutadVentilation | End-Tidal koldioxidKalkon
-
Istanbul UniversityAvslutadpH | Syre | End-tidal koldioxidKalkon
-
AiCuris Anti-infective Cures AGQuintiles, Inc.AvslutadHCMV-reaktivering eller HCMV End-Organ DiseaseFörenta staterna, Tyskland
-
The Cleveland ClinicAvslutadLågt bispektralt index | Lågt medelarteriellt blodtryck | Low End-tidal anestesikoncentrationFörenta staterna
-
Nimmagadda, Usharani, M.D.OkändInspirerat syre (FIO2), End-tidal Oxygen (ETO2), End-tidal Carbon Dioxide (ETCO2) och andningsfrekvens (RR) kommer att mätas var 30:e sekundFörenta staterna
-
Hadassah Medical OrganizationClalit Health Services; Israel Center for Medical Simulation (MSR); The Samuel...OkändEnd of Life ProcessIsrael
-
Zonguldak Bulent Ecevit UniversityAvslutadBröstsjukdomar | Anestesi; Funktionell | Förbrukning av flyktiga medel | Automatisk End-tidal-kontrollerad anestesiKalkon
-
Zuyderland Medisch CentrumAktiv, inte rekryterandeFraktur i övre extremiteten | Fraktur i den distala änden av radien | Fraktur av Proximal End of Humerus | Fraktur i övre extremiteternaNederländerna
-
Zimmer BiometAktiv, inte rekryterandeReumatoid artrit | Avaskulär nekros | Artros i axeln | Fraktur av Proximal End of Humerus | Korrigering av funktionell deformitet | Cuff Tear Artropati | Tidigare misslyckad revisionFörenta staterna
Kliniska prövningar på a psycho-social investigation
-
University of North Carolina, Chapel HillNorth Carolina Translational and Clinical Sciences Institute; Carolina...AvslutadAutism | Socialt beteendeFörenta staterna
-
University of WashingtonNational Institute of Mental Health (NIMH)AvslutadBipolär sjukdomFörenta staterna
-
Microclinic InternationalRoyal Health Awareness Society (RHAS); Jordanian Ministry of Health (MoH)AvslutadHyperglykemi | Hypertoni | Fetma | Diabetes mellitus, typ 2 | Diabetes mellitus | Diabetes | Kroppsvikt | Viktminskning | Blodtryck | Viktökning | Socialt beteende | Vikt, kropp | Glukos, högt blod | Livsstil, hälsosam | Viktförändring, kropp | Beteende, hälsa | Livsstilsriskminskning | Blodtryck, högt | Hyperglykemi (diabetiker) | Vi...Jordanien