Psychosocial Approach and Sedation Practices

• Conditions: End Stage Cancer
• Interventions: Other: a psycho-social investigation

• Registration Number: NCT04016038
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

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 Timeline

• Study First Submitted: 2019-04-16
• Study Start: 2019-06-01
• Status Verified: 2019-07
• Primary Completion: 2019-07-01
• Study First Submitted QC: 2019-07-10
• Last Update Submitted: 2019-07-10
• Study First Posted: 2019-07-11
• Last Update Posted: 2019-07-11
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
QualiPas clinical interview	a psycho-social investigation	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	a psycho-social investigation	Qualitative study by group focus group interviews with clinical teams participating in the project.
QualiPas Observational	a psycho-social investigation	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.

Primary Outcome Measures

Name	Time	Method
Assessing the quality of life	36 months	Quality of Life Questionnaire

Trial Locations

Locations (2)

Assistance des Hôpitaux de Marseille; 🇫🇷 Marseille, France

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France