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Psychosocial Approach and Sedation Practices

10 juli 2019 bijgewerkt door: Assistance Publique Hopitaux De Marseille

Sedation in Palliative Care Management Context for Cancer Patients

This study aims to explore deeply the representations and emotional impact of MS on caregivers (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.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Verwacht)

110

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Frankrijk
      • Marseille, Frankrijk, 13354
        • Werving
        • Assistance Publique Hôpitaux de Marseille
      • Marseille, Frankrijk, 13354

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

In the framework of the QualiPaS_OBS study, the observations will be made by a psychologist integrated into each care team during the observations observation period - no professional activity other than observations. The population studied in the QualiPaS_OBS phase corresponds to the members of the health care team practicing within the eight teams of the services participating in the study, as well as secondarily the patients and relatives of the patients concerned by the activity of the team in question. during the observation period.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Ander: a psycho-social investigation
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.
Ander: a psycho-social investigation
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.
Ander: a psycho-social investigation
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Assessing the quality of life
Tijdsspanne: 36 months
Quality of Life Questionnaire
36 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Assistance Publique Hopitaux De Marseille

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juni 2019

Primaire voltooiing (Verwacht)

1 juli 2019

Studie voltooiing (Verwacht)

1 juli 2022

Studieregistratiedata

Eerst ingediend

16 april 2019

Eerst ingediend dat voldeed aan de QC-criteria

10 juli 2019

Eerst geplaatst (Werkelijk)

11 juli 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 juli 2019

Laatste update ingediend die voldeed aan QC-criteria

10 juli 2019

Laatst geverifieerd

1 juli 2019

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 2018-64

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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