Patient Having a CancerDANCT02634632
Assessments and Recommendations for the Implementation of Advance Directives in Oncology
A study testing Choosing to write advance directives in people with Patient Having a Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Patient Having a Cancer
- What is being tested?
- Choosing to write advance directives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille
Marseille, 13354
DESALBRES Urielle, Director, 0491382747, drci@ap-hm.fr
BARLESI Fabrice, puph
About this study
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.
- Conditions
- Patient Having a Cancer
- Being tested
- Choosing to write advance directives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choosing to write advance directivesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Subjects with cancer | Experimental | choose to write advance directives Receives: Behavioral: Choosing to write advance directives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the rate of use of advance directives
survey
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Having a CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634632
- Sponsor's protocol ID
- 2015-22
- Other IDs
- 2015-A00692-47, RCAPHM15_0141
- Acronym
- DA
- Status last verified
- Dec 2015
- First submitted
- 16 Dec 2015
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessments and Recommendations for the Implementation of Advance Directives in Oncology
- ClinicalTrials.gov ID
- NCT02634632
- Acronym / sponsor ID
- DA / 2015-22
- Conditions
- Patient Having a Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with cancer | Experimental | Behavioral: Choosing to write advance directiveschoose to write advance directives |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Choosing to write advance directives | Behavioural | Subjects with cancer |
Primary outcome
Evaluation the rate of use of advance directives
Time frame: 24 months
survey
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Choosing to write advance directives in people with Patient Having a Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DESALBRES Urielle, Director (0491382747, drci@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation the rate of use of advance directives (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2015.