<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02207543</url>
  </required_header>
  <id_info>
    <org_study_id>PALSATIS</org_study_id>
    <nct_id>NCT02207543</nct_id>
  </id_info>
  <brief_title>Assessment of Patient Satisfaction in Palliative Cancer When They Return Home After Hospitalization in Palliative Care</brief_title>
  <official_title>Assessment of Patient Satisfaction in Palliative Cancer When They Return Home After Hospitalization in Palliative Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Francois Baclesse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Francois Baclesse</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed work is part of a multidisciplinary approach to continuity of care in the&#xD;
      particular context of the palliative phase of cancer. In conducting this study, we would like&#xD;
      to characterize, at the regional level, satisfaction with the care of patients and their&#xD;
      families in their care home situations palliative cancer. This evaluation will be based on&#xD;
      questionnaires adapted versions in French language satisfaction questionnaires recently&#xD;
      validated for patients in palliative situation and supported home care.&#xD;
&#xD;
      It will also identify the challenges faced by both patients, caregivers attending physicians.&#xD;
&#xD;
      The evaluation of these elements is a prerequisite to propose ways of improving at a hospital&#xD;
      palliative care for output relay and anticipate the coordination of care for optimal care of&#xD;
      the patient at home, to meet the expectations of different stakeholders, or even prevent&#xD;
      certain readmissions &quot;avoidable&quot;.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      - Background and rationale of the research project Palliative care is defined, according to&#xD;
      the French Society for Support and Palliative Care as acute care delivered in a comprehensive&#xD;
      approach to the person with a serious illness, progressive or terminal. Their goal is to&#xD;
      relieve physical pain and other symptoms, but also take into account the psychological,&#xD;
      social and spiritual suffering. According to this definition, palliative care is&#xD;
      interdisciplinary, cater to the patient as a person and his family, at home or in an&#xD;
      institution and strive to preserve the best possible quality of life until death.&#xD;
&#xD;
      Very few studies on the quality of life for patients at end of life were conducted in France.&#xD;
      Among them, the TRAPADO study is a prospective study to evaluate the quality of care, quality&#xD;
      of life and impact on the environment in three parallel cohorts of cancer patients in&#xD;
      palliative phase according to their choice of inpatient traditional in palliative care or&#xD;
      home. The interim analysis of this study, was published in 2006 in the journal Bulletin of&#xD;
      cancer: patients expressed a priority choice for the home; there was a marked alteration of&#xD;
      the overall quality of life, as measured by the EORTC-QLQC30, no statistically significant&#xD;
      difference between home and hospital; anxiety level was higher in the hospital. Relatives&#xD;
      were satisfied with the care of the patient with a good perception of the family fabric and&#xD;
      expressed a lower level of psychosocial distress at home. Nevertheless, the terminal&#xD;
      readmissions were common with a large majority of hospital deaths.&#xD;
&#xD;
      More recently, Régis Aubry, in the framework of the National Observatory on End of Life&#xD;
      (ONFV), has conducted an extensive field survey, published in March 2013, up to the&#xD;
      caregivers who meet together near home but also health professionals involved in supporting&#xD;
      patients at end of life. The report of this work highlights the importance of developing&#xD;
      palliative care in the home including the intervention of specialized teams and coordination&#xD;
      of teams working at home.&#xD;
&#xD;
      Indeed, in France, while 81% of the French would &quot;spend their last moments at home&quot; (FIFG,&#xD;
      2010), only 25.5% of deaths occur at home (ONFV, 2012).&#xD;
&#xD;
      Faced with this reality, we were asked to know what elements can explain this discrepancy&#xD;
      between this reality and the desire of patients. This issue was the subject of a preliminary&#xD;
      study, conducted in 2013 in Lower Normandy region. We chose to study the management of&#xD;
      patients with cancer in palliative home situation by their GP after hospitalization&#xD;
      Identified beds Palliative Care (LISP) Centre François Baclesse Caen: 19 of the 23 patients&#xD;
      assessed, have expressed their willingness on the place of death to their GP, wanted to die&#xD;
      at home. Nearly half (48%) of patients in our study died in the hospital. GPs interviewed&#xD;
      reported that maintaining the homes of these patients had been facilitated by the relief of&#xD;
      distressing symptoms and the establishment of aid.&#xD;
&#xD;
      This finding demonstrates that the GP can often not only coordinate the sometimes complex&#xD;
      palliative situations, at home and that the intervention of specialized teams,&#xD;
      interdisciplinary, is fundamental to maintaining a home in the best possible conditions.&#xD;
&#xD;
      But what about the patient felt about his quality of life at home? After collecting feedback&#xD;
      from GPs Lower Normandy, we would like to continue this work. In this context, we propose a&#xD;
      pilot study, single-center, to assess the satisfaction of patients and their families in home&#xD;
      support palliative phase of cancer.&#xD;
&#xD;
      - Emerging nature of research topics covered: The proposed work is part of a&#xD;
      multidisciplinary approach to continuity of care in the particular context of the palliative&#xD;
      phase of cancer. In conducting this study, we would like to characterize, at the regional&#xD;
      level, satisfaction with the care of patients and their families in their care home&#xD;
      situations palliative cancer. This evaluation will be based on questionnaires adapted&#xD;
      versions in French language satisfaction questionnaires recently validated for patients in&#xD;
      palliative situation and supported home care.&#xD;
&#xD;
      It will also identify the challenges faced by both patients, caregivers attending physicians.&#xD;
&#xD;
      The evaluation of these elements is a prerequisite to propose ways of improving at a hospital&#xD;
      palliative care for output relay and anticipate the coordination of care for optimal care of&#xD;
      the patient at home, to meet the expectations of different stakeholders, or even prevent&#xD;
      certain readmissions &quot;avoidable&quot;.&#xD;
&#xD;
      - Degree of risk-taking and innovative scientific approach: The situation at the end of life&#xD;
      patient palliative situation of cancer remains a research context underdeveloped. This study&#xD;
      is based on the involvement of patients and their caregivers, at this stage of the disease to&#xD;
      assess their satisfaction with care when returning home after a hospital palliative care. It&#xD;
      proposes indeed used for this self-administered to patients and their caregivers&#xD;
      questionnaires adapted questionnaires in French version of the research team CANHELP.&#xD;
&#xD;
      - Impact and potential consequences of the project: The proposed pilot study should document&#xD;
      the satisfaction What patients in palliative situation of their cancer during their care at&#xD;
      home, as well as those around them, at the regional level. The implementation of this project&#xD;
      will also be used to validate the feasibility of involving these actors in the difficult&#xD;
      context of the end of life, to understand their needs, difficulties and feelings regarding&#xD;
      the effective care . Thereafter, it may be considered a larger study to complete these first&#xD;
      results, before proposing ways to improve whose impact on satisfaction with care remain to be&#xD;
      evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Loss of patients&#xD;
  </why_stopped>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient care satisfaction</measure>
    <time_frame>15 days after their home return</time_frame>
    <description>Evaluation of satisfaction with the care of patients in palliative phase of cancer 15 days after their home return after hospitalization in palliative care.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of the primary caregiver</measure>
    <time_frame>Satisfaction of the primary caregiver will be evaluated at day 15, months 1 to 6</time_frame>
    <description>Evaluation of the satisfaction of the primary caregiver of maintaining the home of his relatives with cancer in palliative phase</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient quality of life</measure>
    <time_frame>Patient quality of life will be evaluated at day 15, months 1 to 6</time_frame>
    <description>Evaluation of the quality of life of patients at home over time.</description>
  </other_outcome>
  <other_outcome>
    <measure>The type and intensity of symptoms</measure>
    <time_frame>The type and intensity of symptoms will be evaluated on day 15, months1 to 6</time_frame>
    <description>Characterize the type and intensity of symptoms, physical and mental, and supported over time;</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Cancer</condition>
  <condition>Palliative Care</condition>
  <condition>Home</condition>
  <arm_group>
    <arm_group_label>Medical telephonecontact</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evaluations will be conducted by telephone 15 days after hospital discharge, 30 days and then every month until 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medical telephone contact</intervention_name>
    <description>Evaluations will be conducted by telephone 15 days after hospital discharge, 30 days and then every month until 6 months.</description>
    <arm_group_label>Medical telephonecontact</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient (s) age (s) of 18 or more;&#xD;
&#xD;
          -  Patient (s) reached (s) from cancer wholly palliative phase (estimated life expectancy&#xD;
             of less than 3 months) in the judgment of the investigator;&#xD;
&#xD;
          -  Patient (s) hospital (s) in palliative care and candidate for a return home;&#xD;
&#xD;
          -  Patient (s) able to communicate with the investigator or his representative;&#xD;
&#xD;
          -  Patient (s) have received clear information on the diagnosis and prognosis of their&#xD;
             disease;&#xD;
&#xD;
          -  Free and informed consent signed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient (s) under guardianship or unable to give informed consent;&#xD;
&#xD;
          -  Patient (s) whose cognitive functions can not be questioned.&#xD;
&#xD;
          -  Patient (s) whose psychological distress does not participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie-Christine GRACH, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre François Baclesse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre François Baclesse</name>
      <address>
        <city>Caen</city>
        <zip>14076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>February 9, 2017</last_update_submitted>
  <last_update_submitted_qc>February 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Palliative care</keyword>
  <keyword>home</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02207543
org study id: PALSATIS
nct id: NCT02207543
lead sponsor: 
has dmc: Yes
The proposed work is part of a multidisciplinary approach to continuity of care in the
      particular context of the palliative phase of cancer. In conducting this study, we would like
      to characterize, at the regional level, satisfaction with the care of patients and their
      families in their care home situations palliative cancer. This evaluation will be based on
      questionnaires adapted versions in French language satisfaction questionnaires recently
      validated for patients in palliative situation and supported home care.

      It will also identify the challenges faced by both patients, caregivers attending physicians.

      The evaluation of these elements is a prerequisite to propose ways of improving at a hospital
      palliative care for output relay and anticipate the coordination of care for optimal care of
      the patient at home, to meet the expectations of different stakeholders, or even prevent
      certain readmissions "avoidable".
- Background and rationale of the research project Palliative care is defined, according to
      the French Society for Support and Palliative Care as acute care delivered in a comprehensive
      approach to the person with a serious illness, progressive or terminal. Their goal is to
      relieve physical pain and other symptoms, but also take into account the psychological,
      social and spiritual suffering. According to this definition, palliative care is
      interdisciplinary, cater to the patient as a person and his family, at home or in an
      institution and strive to preserve the best possible quality of life until death.

      Very few studies on the quality of life for patients at end of life were conducted in France.
      Among them, the TRAPADO study is a prospective study to evaluate the quality of care, quality
      of life and impact on the environment in three parallel cohorts of cancer patients in
      palliative phase according to their choice of inpatient traditional in palliative care or
      home. The interim analysis of this study, was published in 2006 in the journal Bulletin of
      cancer: patients expressed a priority choice for the home; there was a marked alteration of
      the overall quality of life, as measured by the EORTC-QLQC30, no statistically significant
      difference between home and hospital; anxiety level was higher in the hospital. Relatives
      were satisfied with the care of the patient with a good perception of the family fabric and
      expressed a lower level of psychosocial distress at home. Nevertheless, the terminal
      readmissions were common with a large majority of hospital deaths.

      More recently, Régis Aubry, in the framework of the National Observatory on End of Life
      (ONFV), has conducted an extensive field survey, published in March 2013, up to the
      caregivers who meet together near home but also health professionals involved in supporting
      patients at end of life. The report of this work highlights the importance of developing
      palliative care in the home including the intervention of specialized teams and coordination
      of teams working at home.

      Indeed, in France, while 81% of the French would "spend their last moments at home" (FIFG,
      2010), only 25.5% of deaths occur at home (ONFV, 2012).

      Faced with this reality, we were asked to know what elements can explain this discrepancy
      between this reality and the desire of patients. This issue was the subject of a preliminary
      study, conducted in 2013 in Lower Normandy region. We chose to study the management of
      patients with cancer in palliative home situation by their GP after hospitalization
      Identified beds Palliative Care (LISP) Centre François Baclesse Caen: 19 of the 23 patients
      assessed, have expressed their willingness on the place of death to their GP, wanted to die
      at home. Nearly half (48%) of patients in our study died in the hospital. GPs interviewed
      reported that maintaining the homes of these patients had been facilitated by the relief of
      distressing symptoms and the establishment of aid.

      This finding demonstrates that the GP can often not only coordinate the sometimes complex
      palliative situations, at home and that the intervention of specialized teams,
      interdisciplinary, is fundamental to maintaining a home in the best possible conditions.

      But what about the patient felt about his quality of life at home? After collecting feedback
      from GPs Lower Normandy, we would like to continue this work. In this context, we propose a
      pilot study, single-center, to assess the satisfaction of patients and their families in home
      support palliative phase of cancer.

      - Emerging nature of research topics covered: The proposed work is part of a
      multidisciplinary approach to continuity of care in the particular context of the palliative
      phase of cancer. In conducting this study, we would like to characterize, at the regional
      level, satisfaction with the care of patients and their families in their care home
      situations palliative cancer. This evaluation will be based on questionnaires adapted
      versions in French language satisfaction questionnaires recently validated for patients in
      palliative situation and supported home care.

      It will also identify the challenges faced by both patients, caregivers attending physicians.

      The evaluation of these elements is a prerequisite to propose ways of improving at a hospital
      palliative care for output relay and anticipate the coordination of care for optimal care of
      the patient at home, to meet the expectations of different stakeholders, or even prevent
      certain readmissions "avoidable".

      - Degree of risk-taking and innovative scientific approach: The situation at the end of life
      patient palliative situation of cancer remains a research context underdeveloped. This study
      is based on the involvement of patients and their caregivers, at this stage of the disease to
      assess their satisfaction with care when returning home after a hospital palliative care. It
      proposes indeed used for this self-administered to patients and their caregivers
      questionnaires adapted questionnaires in French version of the research team CANHELP.

      - Impact and potential consequences of the project: The proposed pilot study should document
      the satisfaction What patients in palliative situation of their cancer during their care at
      home, as well as those around them, at the regional level. The implementation of this project
      will also be used to validate the feasibility of involving these actors in the difficult
      context of the end of life, to understand their needs, difficulties and feelings regarding
      the effective care . Thereafter, it may be considered a larger study to complete these first
      results, before proposing ways to improve whose impact on satisfaction with care remain to be
      evaluated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Patient care satisfaction
time frame: 15 days after their home return
description: Evaluation of satisfaction with the care of patients in palliative phase of cancer 15 days after their home return after hospitalization in palliative care.
measure: Satisfaction of the primary caregiver
time frame: Satisfaction of the primary caregiver will be evaluated at day 15, months 1 to 6
description: Evaluation of the satisfaction of the primary caregiver of maintaining the home of his relatives with cancer in palliative phase
measure: Patient quality of life
time frame: Patient quality of life will be evaluated at day 15, months 1 to 6
description: Evaluation of the quality of life of patients at home over time.
measure: The type and intensity of symptoms
time frame: The type and intensity of symptoms will be evaluated on day 15, months1 to 6
description: Characterize the type and intensity of symptoms, physical and mental, and supported over time;
arm group label: Medical telephonecontact
arm group type: Experimental
description: Evaluations will be conducted by telephone 15 days after hospital discharge, 30 days and then every month until 6 months.
intervention type: Other
intervention name: Medical telephone contact
description: Evaluations will be conducted by telephone 15 days after hospital discharge, 30 days and then every month until 6 months.
arm group label: Medical telephonecontact
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marie-Christine GRACH, MD
role: Principal Investigator
affiliation: Centre François Baclesse
facility: 
country: France
responsible party type: Sponsor