Advance DirectivesPADAONCODERMNCT03822988
ACCEPTABILITY AND WRITING FREQUENCY OF ADVANCED DIRECTIVES IN ONCO-DERMATOLOGY PATIENTS
An observational study of Advance Directives and Oncology, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The law about advance directives is evolving but, in France, few people write it. Te main endpoint of this research is to estimate the proportion of patients who have written their advance directives or considering doing so in onco-dermatologic population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advance Directives, Oncology, Skin Cancer
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2019to 20 Jun 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cf beyond
Who may be able to join
- > 18 ya
- With one of the diagnoses below:
- Melanoma
- Skin lymphoma
- Meckel Carcinoma
- localy advanced or metastatic Basal cell carcinoma or squamous cell carcinoma
Who cannot join
- Patients not in possession of all of its cognitive abilities Patients who can't read patients who don't speak french
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU Nancy-Brabois hospital
Vandœuvre-lès-Nancy, 54500
anne-claire Bursztejn, ac-bursztejn@chru-nancy.fr
About this study
The law about advance directives is evolving but, in France, few people write it.
Te main endpoint of this research is to estimate the proportion of patients who have written their advance directives or considering doing so in onco-dermatologic population. If this rate remains low, some insights on the reasons will be able to be advanced looking at the point of view and opinion of patients about this topic.
Read more
Seconds endpoints are :
For patients against or not planning to write it, understand their reasons
Estimate the proportion of patients requesting information and understand how they would like to receive it.
Investigate a possible association between the stage of the oncological disease and the positioning of the patient concerning advance directives.
- Conditions
- Advance Directives, Oncology, Skin Cancer, Melanoma, Skin Lymphoma, Skin Squamous Cell Carcinoma
- Being tested
- no intervention, only complete a survey
- Keywords
- advance directives, Advance care planning, Patient's informed, treatment preferences, skin cancer, dermatology
- Medical subject headings
- Neoplasms, Skin Neoplasms, Melanoma, Lymphoma, T-Cell, Cutaneous, Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, only complete a surveyOther
we will ask patients to answer to a survey
| Study group | Role | What they receive |
|---|---|---|
| patients accepting to answer to the survey | patients with a skin lymphoma OR melanoma OR advanced skin squamous cell carcinoma OR advanced basal cell carcinoma accepting to answer to the anonymous survey Receives: Other: no intervention, only complete a survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Writing by the patient of its advance directives
Writing by the patient of his advance directves and, if not writing, positioning of the patient (rather favorable or rather unfavorable) as to the writing of his advance directives.
Measured: when the patient complete the survey
Secondary outcomes (2)
reason for not writing advance directives
In patients who have not written their advance directives: reason for not writing the advance directives.
Measured: when the patient complete the survey
Patient wishing to be more informed about the adavance directives during its management and, if so, by what means.
Measured: when the patient complete the survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start21 Jan 2019
- Primary completion20 Jun 2019 (estimated)
- Study completion20 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance DirectivesStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- anne-claire bursztejn, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822988
- Sponsor's protocol ID
- PSS-2018/PADAONCODERM
- Acronym
- PADAONCODERM
- Status last verified
- Jan 2019
- First submitted
- 28 Jan 2019
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACCEPTABILITY AND WRITING FREQUENCY OF ADVANCED DIRECTIVES IN ONCO-DERMATOLOGY PATIENTS
- ClinicalTrials.gov ID
- NCT03822988
- Acronym / sponsor ID
- PADAONCODERM / PSS-2018/PADAONCODERM
- Conditions
- Advance Directives, Oncology, Skin Cancer, Melanoma, Skin Lymphoma, Skin Squamous Cell Carcinoma
- Keywords
- advance directives, Advance care planning, Patient's informed, treatment preferences, skin cancer, dermatology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 20 Jun 2019 (estimated)
- Study completion
- 20 Jun 2019 (estimated)
- First posted
- 30 Jan 2019 (actual)
- 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.
The law about advance directives is evolving but, in France, few people write it.
Te main endpoint of this research is to estimate the proportion of patients who have written their advance directives or considering doing so in onco-dermatologic population. If this rate remains low, some insights on the reasons will be able to be advanced looking at the point of view and opinion of patients about this topic.
Seconds endpoints are :
For patients against or not planning to write it, understand their reasons
Estimate the proportion of patients requesting information and understand how they would like to receive it.
Investigate a possible association between the stage of the oncological disease and the positioning of the patient concerning advance directives.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients accepting to answer to the survey | – | Other: no intervention, only complete a surveypatients with a skin lymphoma OR melanoma OR advanced skin squamous cell carcinoma OR advanced basal cell carcinoma accepting to answer to the anonymous survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cf beyond
Key inclusion criteria (6 listed)
- > 18 ya
- Melanoma
- Skin lymphoma
- Meckel Carcinoma
- localy advanced or metastatic Basal cell carcinoma or squamous cell carcinoma
Key exclusion criteria (1 listed)
- Patients not in possession of all of its cognitive abilities Patients who can't read patients who don't speak french
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 |
|---|---|---|
| no intervention, only complete a surveywe will ask patients to answer to a survey | Other | patients accepting to answer to the survey |
Primary outcome
Writing by the patient of its advance directives
Time frame: when the patient complete the survey
Writing by the patient of his advance directves and, if not writing, positioning of the patient (rather favorable or rather unfavorable) as to the writing of his advance directives.
2 secondary outcomes
reason for not writing advance directives
Time frame: when the patient complete the survey
Patient wishing to be more informed about the adavance directives during its management and, if so, by what means.
Time frame: when the patient complete the survey
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Individual participant dataSharing planned: No
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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.
anne-claire bursztejn principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advance Directives and Oncology, run by Central Hospital, Nancy, France 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 6 inclusion and 1 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 30 Jan 2019. 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 Anne-Claire BURSZTEJN (0383157146, ac-bursztejn@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Writing by the patient of its advance directives (time frame: when the patient complete the survey). 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 30 Jan 2019.