Psychosocial Approach and Sedation Practices

NCT ID: NCT04016038

Last Updated: 2019-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2022-07-01

Brief Summary

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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

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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.

Conditions

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End Stage Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

a psycho-social investigation

Intervention Type OTHER

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.

a psycho-social investigation

Intervention Type OTHER

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.

a psycho-social investigation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emilie Garrido

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Locations

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Assistance des Hôpitaux de Marseille

Marseille, , France

Site Status NOT_YET_RECRUITING

Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lionel DANY, MD/PhD

Role: CONTACT

+336.63.42.41.04

Patrcik SUDOUR

Role: CONTACT

Facility Contacts

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Lionel Dany

Role: primary

06.63.42.41.04

Patrick Sudour

Role: backup

04 91 38 29 03

Lionel Dany, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 34223516 (View on PubMed)

Other Identifiers

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2018-64

Identifier Type: -

Identifier Source: org_study_id

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