Psychosocial Approach and Sedation Practices

End Stage Cancer Clinical Trial

Official title:

Sedation in Palliative Care Management Context for Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04016038
• Other study ID #: 2018-64
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2019
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Lionel DANY, MD/PhD
• Phone: +336.63.42.41.04
• Email: lionel.dany[@]univ-amu.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Cancer

Intervention

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.

Locations

Country	Name	City	State
France	Assistance des Hôpitaux de Marseille	Marseille
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing the quality of life	Quality of Life Questionnaire	36 months