CClinicalTrials.gg
Status unknownNCT02634632DAUpdated Dec 21, 2015

Assessments and Recommendations for the Implementation of Advance Directives in Oncology

An interventional study of Choosing to write advance directives in Patient Having a Cancer, sponsored by Assistance Publique Hopitaux De Marseille. Status unknown at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-12-21.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Dec 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Patient Having a Cancer
03

In context

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Subjects with cancer

    choose to write advance directives

    Behavioral: Choosing to write advance directives

Interventions

  • BehavioralChoosing to write advance directives
06

What researchers measure

Primary outcomes

  1. Evaluation the rate of use of advance directives

    survey

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • Assistance Publique Hôpitaux de Marseille
    Marseille, 13354, France
    • DESALBRES Urielle, Director · Contact · drci@ap-hm.fr · 0491382747
    • BARLESI Fabrice, puph · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02634632
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Dec 18, 2015
Start date
Dec 2015
Primary completion
Dec 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Dec 21, 2015

Study contacts

DESALBRES Urielle, Director
Contact
drci@ap-hm.fr
0491382747
DHORNE Jean, Manager
Contact
jean.dhorne@ap-hm.fr
0491381475

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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