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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04628234
Other study ID # 2020-001
Secondary ID 2020-A00439-30
Status Completed
Phase
First received
Last updated
Start date July 4, 2020
Est. completion date January 9, 2021

Study information

Verified date January 2021
Source Institut de cancérologie Strasbourg Europe
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a non randomized, monocentric, descriptive, transversal and prospective study. The purpose of this study is to assess the compliance with patient expressed choice regarding subsequent care and death -if occured- site (at hospital or at home) after hospitalisation for terminally ill patients with an onco-hematologic solid tumor in palliative care and to identify reasons for potential non-compliance.


Description:

Patients will reply to two questionnaires, at inclusion and two months after inclusion. Primary care physician will also be contacted by phone to reply to two questionnaires, at inclusion and two months after inclusion.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date January 9, 2021
Est. primary completion date January 9, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients must be = 18 years old - Patients with onco-hematologic solid tumor (locally advanced or metastatic) against which specific and systemic treatments are outdated or have been stopped (symptomatic palliation with radiotherapy is allowed) - Patients admitted in full hospitalisation - Patients able to speak, read and understand French - Patients able to answer the phone - Signed informed consent from the patient - Patients must have a social security coverage Exclusion Criteria: - Patients < 18 years old or incapable person = 18 years old - Patients admitted for any surgical intervention - Patients unable to read French - Patients whose physical or psychological condition do not allow them to answer orally or in writing - Patients deprived of liberty - Patients placed under judicial protection - Women that are pregnant or breast-feeding

Study Design


Locations

Country Name City State
France Institut de Cancerologie Strasbourg Europe Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
Institut de cancérologie Strasbourg Europe

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients for which their choice of care and death -if occured- site (at hospital or at home) is respected. Patients will fill out a questionnaire at inclusion and 2 months after inclusion if they are still alive. Death site will be collected from primary care physician if patient died.
The patient expressed choice regarding subsequent care and death site collected in the first questionnaire at inclusion will be compared to the situation at 2 months.
2 months after inclusion
Secondary Number of new hospitalisations occuring after inclusion, if any. 2 months after inclusion
Secondary Duration of new hospitalisations occuring after inclusion, if any. 2 months after inclusion
Secondary Reasons for new hospitalisations occuring after inclusion, if any. 2 months after inclusion
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