NCT03822988

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

January 28, 2019

Last Update Submit

January 28, 2019

Conditions

Advance DirectivesOncologySkin CancerMelanomaSkin LymphomaSkin Squamous Cell CarcinomaMetastatic Basal Cell Carcinoma

Keywords

advance directivesAdvance care planningPatient's informedtreatment preferencesskin cancerdermatology

Outcome Measures

Primary Outcomes (1)

  • 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.

    when the patient complete the survey

Secondary Outcomes (2)

  • reason for not writing 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.

    when the patient complete the survey

Study Arms (1)

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

Interventions

no intervention, only complete a surveyOTHER

we will ask patients to answer to a survey

patients accepting to answer to the survey

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cf beyond

You may qualify if:

  • \> 18 ya
  • With one of the diagnoses below:
  • Melanoma
  • Skin lymphoma
  • Meckel Carcinoma
  • localy advanced or metastatic Basal cell carcinoma or squamous cell carcinoma

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy-Brabois hospital

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

MeSH Terms

Conditions

NeoplasmsSkin NeoplasmsMelanomaLymphoma, T-Cell, CutaneousCarcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Neoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasLymphoma, T-CellLymphoma, Non-HodgkinLymphomaLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Basal Cell

Study Officials

  • anne-claire bursztejn

    CHRU Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Claire BURSZTEJN

CONTACT

0383157146ac-bursztejn@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2019

First Posted

January 30, 2019

Study Start

January 21, 2019

Primary Completion

June 20, 2019

Study Completion

June 20, 2019

Last Updated

January 30, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)