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Follow-up of Actual Patient Care Site Two Months After Hospitalisation Compared With Their Expressed Choice Regarding Subsequent Care Site (RESPECT)

Sponsor
Institut de cancérologie Strasbourg Europe (Other)
Overall Status
Completed
CT.gov ID
NCT04628234
Collaborator
(none)
53
Enrollment
1
Location
6.2
Actual Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    53 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Follow-up of Actual Patient Care Site Two Months After Hospitalisation Compared With Their Expressed Choice Regarding Subsequent Care Site
    Actual Study Start Date :
    Jul 4, 2020
    Actual Primary Completion Date :
    Jan 9, 2021
    Actual Study Completion Date :
    Jan 9, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with an onco-hematologic solid tumor in palliative care

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients for which their choice of care and death -if occured- site (at hospital or at home) is respected. [2 months after inclusion]

      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.

    Secondary Outcome Measures

    1. Number of new hospitalisations occuring after inclusion, if any. [2 months after inclusion]

    2. Duration of new hospitalisations occuring after inclusion, if any. [2 months after inclusion]

    3. Reasons for new hospitalisations occuring after inclusion, if any. [2 months after inclusion]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut de Cancerologie Strasbourg Europe Strasbourg France 67033

    Sponsors and Collaborators

    • Institut de cancérologie Strasbourg Europe

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institut de cancérologie Strasbourg Europe
    ClinicalTrials.gov Identifier:
    NCT04628234
    Other Study ID Numbers:
    • 2020-001
    • 2020-A00439-30
    First Posted:
    Nov 13, 2020
    Last Update Posted:
    Feb 1, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hematologic Neoplasms

    Study Results

    No Results Posted as of Feb 1, 2021