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Assessments and Recommendations for the Implementation of Advance Directives in Oncology

NCT ID: NCT02634632

Last Updated: 2015-12-21

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

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-12-31

Brief Summary

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Legitimized by the Leonetti law of April 22, 2005, advance directives (AD) appear in various places of care that alongside the end of life, and even tend to be generalized to all areas related to health care in general. In this context, a prospective study to assess how the patient will seize the AD and identify the different problems writing these AD will be conducted. From this study, it will establish recommendations for the implementation of AD in the Multidisciplinary Oncology Department and Therapeutic Innovations service and in oncology in general. They will be asked patients if they choose to write their AD, complete and sign the AD pre-written in the book or not to draft their AD. The choice of the patients, but also the reasons they associate thereto and, where appropriate, their AD written will be collected. The patient will also inform its demographic and socio the case report (clinical data) should be completed by the investigator. During the first part of research, the use of AD by patients and will be assessed and analyzed in connection with the characteristics of these patients (history of the disease, course of care, socio-demographic) and the reasons they set out to explain their choice. For those who write their AD, they will, in a second step, subject to thematic content analysis to identify the main aspects that the subject convened to consider its end of life.This research therefore lead to the definition of the contours of a user device AD in oncology in general. This study was qualified biomedical research because of the sensitive nature of the study population and bring the patient to personal preoccupations when filling the questionnaire on the choice of directing advance directives and their contents.

Detailed Description

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Conditions

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Patient Having a Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Subjects with cancer

choose to write advance directives

Group Type EXPERIMENTAL

Choosing to write advance directives

Intervention Type BEHAVIORAL

Interventions

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Choosing to write advance directives

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Subject both sexes
* Subject whose age is between 18 and 85 years
* Subject with cancer
* Subjects for which French is the native language, about having read, understood and signed the informed consent

Exclusion Criteria

* Subject minors or subjects aged over 85 years
* Subject not including the French
* Subject with neurological or psychiatric disorders prohibiting their understanding of the study
* Subject private freedom following a judicial or administrative decision
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 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

Locations

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Assistance Publique Hôpitaux de Marseille

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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DESALBRES Urielle, Director

Role: CONTACT

Phone: 0491382747

Email: [email protected]

DHORNE Jean, Manager

Role: CONTACT

Phone: 0491381475

Email: [email protected]

Facility Contacts

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DESALBRES Urielle, Director

Role: primary

Other Identifiers

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2015-A00692-47

Identifier Type: REGISTRY

Identifier Source: secondary_id

RCAPHM15_0141

Identifier Type: OTHER

Identifier Source: secondary_id

2015-22

Identifier Type: -

Identifier Source: org_study_id