Psychosocial Approach and Sedation Practices

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.

Study Overview

• Status: Unknown
• Conditions: End Stage Cancer
• Intervention / Treatment: Other: a psycho-social investigation

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 110

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Assistance Publique Hopitaux de Marseille
  • Marseille, France, 13354
    • Not yet recruiting
    • Assistance des Hôpitaux de Marseille
    • Contact: Patrick Sudour; Phone Number: 04 91 38 29 03; Email: promotion.interne@ap-hm.fr
    • Contact: Lionel Dany; Phone Number: 06.63.42.41.04; Email: Lionel.Dany@univ-amu.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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.	Other: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing the quality of life	Quality of Life Questionnaire	36 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2018-64

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No