Assessments and Recommendations for the Implementation of Advance Directives in Oncology (DA)

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.

Study Overview

• Status: Unknown
• Conditions: Patient Having a Cancer
• Intervention / Treatment: Behavioral: Choosing to write advance directives

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Assistance Publique Hopitaux de Marseille
    • Contact: DESALBRES Urielle, Director; Phone Number: 0491382747; Email: drci@ap-hm.fr
    • Principal Investigator: BARLESI Fabrice, puph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects with cancer; choose to write advance directives	Behavioral: Choosing to write advance directives

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation the rate of use of advance directives	survey	24 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: December 16, 2015
• First Submitted That Met QC Criteria: December 17, 2015
• First Posted (Estimate): December 18, 2015

Study Record Updates

• Last Update Posted (Estimate): December 21, 2015
• Last Update Submitted That Met QC Criteria: December 18, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 2015-22; 2015-A00692-47 (Registry Identifier: ID RCB); RCAPHM15_0141 (Other Identifier: AP-HM)