ACCEPTABILITY AND WRITING FREQUENCY OF ADVANCED DIRECTIVES IN ONCO-DERMATOLOGY PATIENTS (PADAONCODERM)

January 28, 2019 updated by: Central Hospital, Nancy, France

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cf beyond

Description

Inclusion Criteria:

> 18 ya

With one of the diagnoses below:

  • Melanoma
  • Skin lymphoma
  • Meckel Carcinoma
  • localy advanced or metastatic Basal cell carcinoma or squamous cell carcinoma

Exclusion Criteria:

Patients not in possession of all of its cognitive abilities Patients who can't read patients who don't speak french

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: no intervention, only complete a survey
we will ask patients to answer to a survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
when the patient complete the survey

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reason for not writing advance directives
Time Frame: when the patient complete the survey
In patients who have not written their advance directives: reason for not writing the advance directives.
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
when the patient complete the survey

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: anne-claire bursztejn, CHRU Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2019

Primary Completion (Anticipated)

June 20, 2019

Study Completion (Anticipated)

June 20, 2019

Study Registration Dates

First Submitted

January 28, 2019

First Submitted That Met QC Criteria

January 28, 2019

First Posted (Actual)

January 30, 2019

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSS-2018/PADAONCODERM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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