Skip to main content
Clinical Trials/NCT04016038
NCT04016038
Unknown
Not Applicable

Sedation in Palliative Care Management Context for Cancer Patients

Assistance Publique Hopitaux De Marseille2 sites in 1 country110 target enrollmentJune 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
End Stage Cancer
Sponsor
Assistance Publique Hopitaux De Marseille
Enrollment
110
Locations
2
Primary Endpoint
Assessing the quality of life
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
July 1, 2022
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Assessing the quality of life

Time Frame: 36 months

Quality of Life Questionnaire

Study Sites (2)

Loading locations...

Similar Trials