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Completed

NCT Number: NCT04628234

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

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.

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Key information

Conditions

Hematologic Malignancy Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site Tumor, Solid

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut de Cancerologie Strasbourg Europe

Strasbourg, 67033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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with onco-hematologic solid tumor (locally advanced or metastatic) against which specific and systemic treatments are outdated or have been stopped (symptomatic palliation with radiotherapy is allowed)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

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  1. Number of new hospitalisations occuring after inclusion, if any.

    Time frame: 2 months after inclusion

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

    Time frame: 2 months after inclusion

  3. Reasons for new hospitalisations occuring after inclusion, if any.

    Time frame: 2 months after inclusion

Sponsors and collaborators

Lead sponsor

Institut de cancérologie Strasbourg Europe

Other

Registry information

Official study title

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

Acronym: RESPECT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 13, 2020
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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