Psychosocial Approach and Sedation Practices
Sedation in Palliative Care Management Context for Cancer Patients
1 other identifier
observational
110
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2019
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedFirst Posted
Study publicly available on registry
July 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedJuly 11, 2019
July 1, 2019
1 month
April 16, 2019
July 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Assessing the quality of life
Quality of Life Questionnaire
36 months
Study Arms (3)
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.
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.
QualiPas Focus
Qualitative study by group focus group interviews with clinical teams participating in the project.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Men and women
- Anyone from the team during the observation period
- Having accepted the presence of the observer
- Aged over 18
You may not qualify if:
- Members of the health care team not present during the observation period
- Member of the team refusing the presence of the observer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Assistance des Hôpitaux de Marseille
Marseille, 13354, France
Assistance Publique Hopitaux de Marseille
Marseille, 13354, France
Related Publications (1)
Vieille M, Dany L, Coz PL, Avon S, Keraval C, Salas S, Bernard C. Perception, Beliefs, and Attitudes Regarding Sedation Practices among Palliative Care Nurses and Physicians: A Qualitative Study. Palliat Med Rep. 2021 May 24;2(1):160-167. doi: 10.1089/pmr.2021.0022. eCollection 2021.
PMID: 34223516DERIVED
Study Officials
- STUDY DIRECTOR
Emilie Garrido
Assistance Publique Hopitaux De Marseille
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 36 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2019
First Posted
July 11, 2019
Study Start
June 1, 2019
Primary Completion
July 1, 2019
Study Completion
July 1, 2022
Last Updated
July 11, 2019
Record last verified: 2019-07