Psychosocial Approach and Sedation Practices

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Unknown

Conditions: End Stage Cancer

Treatments: Other: a psycho-social investigation

Study type: Observational

Funder types: Other

Identifiers

NCT04016038

2018-64

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

110 participants in 3 patient groups

QualiPas Observational

Description:

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.

Treatment:

Other: a psycho-social investigation

QualiPas clinical interview

Description:

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.

Treatment:

Other: a psycho-social investigation

QualiPas Focus

Description:

Qualitative study by group focus group interviews with clinical teams participating in the project.

Treatment:

Other: a psycho-social investigation