<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/NCT02208908</url>
  </required_header>
  <id_info>
    <org_study_id>BBC3</org_study_id>
    <nct_id>NCT02208908</nct_id>
  </id_info>
  <brief_title>Oral Care and Cancer: Assessing the Contribution of Training Healthcare Teams to Support the Oral Status of Patients Hospitalized in Palliative Situation</brief_title>
  <official_title>Oral Care and Cancer: Assessing the Contribution of Training Healthcare Teams to Support the Oral Status of Patients Hospitalized in Palliative Situation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Francois Baclesse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ligue contre le cancer, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Francois Baclesse</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to measure the impact of training on the practical assessment&#xD;
      and management of the oral status of patients hospitalized in palliative situation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the French support and palliative care (RFS) Company, palliative care are active&#xD;
      in a holistic approach to the person with a serious illness, progressive or terminal. Their&#xD;
      goal is to relieve physical symptoms and other pain and take into account the psychological,&#xD;
      social and spiritual suffering.&#xD;
&#xD;
      He consensus among caregivers to recognize the importance and maintaining good oral hygiene&#xD;
      for patients treated for cancer at all ages of life, home and in hospital, and consider that&#xD;
      the oral hygiene is an integral part of nursing, toilet and contributes to the health of&#xD;
      patients. This is primarily a comfort for the person to have a healthy mouth, healthy with a&#xD;
      clean mouth, but also a tool that meets all its features.&#xD;
&#xD;
      The feeding, respiration and communication are three closely related to the proper&#xD;
      functioning of the oral cavity needs. Furthermore, cancer, various treatments, age are&#xD;
      possible disturbances oral integrity. The nurse helped the caregiver has upstream of care,&#xD;
      the role of counseling and prevention. However, a review of the oral and / or the&#xD;
      establishment of procedures support oral hygiene status are largely neglected despite the&#xD;
      existence of published recommendations. This is particularly related to lack of information&#xD;
      provided and continuing education offered to carers and the lack of written procedures.&#xD;
      Moreover, the limited literature on the subject limit the possibility of initiatives, the&#xD;
      establishment of a procedure before relying on evidence-based practice. Measure 43 Cancer&#xD;
      Plan I and the establishment of mobile units or palliative care teams and management of pain&#xD;
      in Residential Care (especially CHU and Centres for the Fight Against Cancer [PBC] ) is an&#xD;
      opportunity to implement an audit action.&#xD;
&#xD;
      This project is part of a research program in several steps. From November 2010 to August&#xD;
      2011, 260 patients (107 hommes/153 women), median age 64 years (19-88 years) were included.&#xD;
      J2, a healthy mouth, moderately (dry mouth and / or dirty) or severely (fungal mouth and / or&#xD;
      painful ulcerated and / or hemorrhagic) was altered respectively observed for 61 (23.5%), 139&#xD;
      (53.5%) and 60 (23.0%) patients. Traceability of this oral assessment is found in 10% of&#xD;
      cases. The exit assessment was performed in 184 patients (46 deaths, 30 non-assessed),&#xD;
      including 129 with a delay ≥ 5 days between J2 and output. The mouth on the output shows a&#xD;
      healthy mouth, moderately and severely impaired in 33 (26%), 70 (54%) and 26 (20%) of these&#xD;
      129 patients, respectively. Thus, 27 (21%) patients showed deterioration in their oral&#xD;
      condition during hospitalization: 13/31 (42%) for patients with a healthy mouth to J2 and&#xD;
      14/72 (19%) for those with a mouth moderately altered to J2. In contrast, 28/129 (22%)&#xD;
      patients, including 13/72 (18%) and 15/26 (58%) respectively had a mouth moderately and&#xD;
      severely impaired the initial assessment have improved access to oral output state .&#xD;
&#xD;
      Following this audit action, a tool Medical Assessment mouth has been prepared in&#xD;
      collaboration with health care teams participating as well as recommendations for management&#xD;
      of each type of mouth (concerning both hygiene as drug and non-drug measures), in agreement&#xD;
      with those of learned societies, a plan of care by type of mouth care.&#xD;
&#xD;
      An inter centers presenting the results of the first stage (inventory) and definition of the&#xD;
      training plan was held in March 2013 in the presence, for each center, doctor, and nurse care&#xD;
      manager and / or scope of health involved in palliative care and research program. The&#xD;
      purpose of this meeting was to present the evaluation grid of mouth and recommendations&#xD;
      developed state care and the plan and tools for training healthcare teams on site.&#xD;
&#xD;
      From May to September 2013, personnel, formed during this meeting, provide training for&#xD;
      paramedical and medical teams of their establishment.&#xD;
&#xD;
      The purpose of this study is to measure the impact of training on the practical assessment&#xD;
      and management of the oral status of patients hospitalized in palliative situation.&#xD;
&#xD;
      Expected results We hope that the appropriate training of health care teams allow all&#xD;
      patients during their hospitalization benefit systematically evaluate the oral condition, the&#xD;
      implementation of actions consistent with the recommendations and thus an improvement the&#xD;
      care of their oral condition.&#xD;
&#xD;
      Ultimately, it is hoped that the management of the oral condition falls within the overall&#xD;
      care of the patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients with an improvement of 10% of the buccal state</measure>
    <time_frame>up to day 15</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The quality and adequacy of the prescription (non-drug and / or drug attitudes) to record oral</measure>
    <time_frame>Day 2 and 15</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">280</enrollment>
  <condition>Management of Oral Care and Cancer in Palliative Situation</condition>
  <arm_group>
    <arm_group_label>Patient with cancer hospitalize inpalliative situation</arm_group_label>
    <description>An accurate assessment of the oral condition and proper care will be carried out on day 2 (J2) of hospitalization and repeated on the day of hospital discharge by the nurse detached service, regardless of caregivers.&#xD;
An assessment of the traceability of clinical assessment and appropriate treatment prescribed or will be conducted on day 3 and repeated the day of the release of hospitalization (or day 15) from information recorded in the patient record</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evaluation of the oral conditionand proper care</intervention_name>
    <description>An accurate assessment of the oral condition and proper care will be carried out on day 2 (J2) of hospitalization and repeated on the day of hospital discharge by the nurse detached service, regardless of caregivers.</description>
    <arm_group_label>Patient with cancer hospitalize inpalliative situation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with cancer hospitalize inpalliative situation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged over 18 years with cancer and palliative hospital situation&#xD;
&#xD;
          -  Patient able to communicate with the nursing staff;&#xD;
&#xD;
          -  Patient able to understand the meaning of the questions;&#xD;
&#xD;
          -  Patients whose length of stay is at least 5 days&#xD;
&#xD;
          -  Patients whose life expectancy is greater than or equal to three weeks;&#xD;
&#xD;
          -  Patients who have given their written consent to the study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusing to make the clinical assessment;&#xD;
&#xD;
          -  Patient not giving their consent for participation;&#xD;
&#xD;
          -  Patient unable to communicate with the nursing staff;&#xD;
&#xD;
          -  Patient not proficient in the French language;&#xD;
&#xD;
          -  Patient suffering from cognitive deficits.&#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>Institut de Cancérologie de l'Ouest</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre François Baclesse</name>
      <address>
        <city>Caen</city>
        <zip>14076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Oscar Lambret</name>
      <address>
        <city>Lille</city>
        <zip>59020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie de l'Ouest</name>
      <address>
        <city>Nantes</city>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Henri Becquerel</name>
      <address>
        <city>Rouen</city>
        <zip>76038</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 5, 2015</last_update_submitted>
  <last_update_submitted_qc>August 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oral care</keyword>
  <keyword>cancer</keyword>
  <keyword>palliative</keyword>
  <keyword>training</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/NCT02208908
org study id: BBC3
nct id: NCT02208908
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to measure the impact of training on the practical assessment
      and management of the oral status of patients hospitalized in palliative situation.
According to the French support and palliative care (RFS) Company, palliative care are active
      in a holistic approach to the person with a serious illness, progressive or terminal. Their
      goal is to relieve physical symptoms and other pain and take into account the psychological,
      social and spiritual suffering.

      He consensus among caregivers to recognize the importance and maintaining good oral hygiene
      for patients treated for cancer at all ages of life, home and in hospital, and consider that
      the oral hygiene is an integral part of nursing, toilet and contributes to the health of
      patients. This is primarily a comfort for the person to have a healthy mouth, healthy with a
      clean mouth, but also a tool that meets all its features.

      The feeding, respiration and communication are three closely related to the proper
      functioning of the oral cavity needs. Furthermore, cancer, various treatments, age are
      possible disturbances oral integrity. The nurse helped the caregiver has upstream of care,
      the role of counseling and prevention. However, a review of the oral and / or the
      establishment of procedures support oral hygiene status are largely neglected despite the
      existence of published recommendations. This is particularly related to lack of information
      provided and continuing education offered to carers and the lack of written procedures.
      Moreover, the limited literature on the subject limit the possibility of initiatives, the
      establishment of a procedure before relying on evidence-based practice. Measure 43 Cancer
      Plan I and the establishment of mobile units or palliative care teams and management of pain
      in Residential Care (especially CHU and Centres for the Fight Against Cancer [PBC] ) is an
      opportunity to implement an audit action.

      This project is part of a research program in several steps. From November 2010 to August
      2011, 260 patients (107 hommes/153 women), median age 64 years (19-88 years) were included.
      J2, a healthy mouth, moderately (dry mouth and / or dirty) or severely (fungal mouth and / or
      painful ulcerated and / or hemorrhagic) was altered respectively observed for 61 (23.5%), 139
      (53.5%) and 60 (23.0%) patients. Traceability of this oral assessment is found in 10% of
      cases. The exit assessment was performed in 184 patients (46 deaths, 30 non-assessed),
      including 129 with a delay ≥ 5 days between J2 and output. The mouth on the output shows a
      healthy mouth, moderately and severely impaired in 33 (26%), 70 (54%) and 26 (20%) of these
      129 patients, respectively. Thus, 27 (21%) patients showed deterioration in their oral
      condition during hospitalization: 13/31 (42%) for patients with a healthy mouth to J2 and
      14/72 (19%) for those with a mouth moderately altered to J2. In contrast, 28/129 (22%)
      patients, including 13/72 (18%) and 15/26 (58%) respectively had a mouth moderately and
      severely impaired the initial assessment have improved access to oral output state .

      Following this audit action, a tool Medical Assessment mouth has been prepared in
      collaboration with health care teams participating as well as recommendations for management
      of each type of mouth (concerning both hygiene as drug and non-drug measures), in agreement
      with those of learned societies, a plan of care by type of mouth care.

      An inter centers presenting the results of the first stage (inventory) and definition of the
      training plan was held in March 2013 in the presence, for each center, doctor, and nurse care
      manager and / or scope of health involved in palliative care and research program. The
      purpose of this meeting was to present the evaluation grid of mouth and recommendations
      developed state care and the plan and tools for training healthcare teams on site.

      From May to September 2013, personnel, formed during this meeting, provide training for
      paramedical and medical teams of their establishment.

      The purpose of this study is to measure the impact of training on the practical assessment
      and management of the oral status of patients hospitalized in palliative situation.

      Expected results We hope that the appropriate training of health care teams allow all
      patients during their hospitalization benefit systematically evaluate the oral condition, the
      implementation of actions consistent with the recommendations and thus an improvement the
      care of their oral condition.

      Ultimately, it is hoped that the management of the oral condition falls within the overall
      care of the patient.
observational model: Cohort
time perspective: Prospective
measure: Proportion of patients with an improvement of 10% of the buccal state
time frame: up to day 15
measure: The quality and adequacy of the prescription (non-drug and / or drug attitudes) to record oral
time frame: Day 2 and 15
arm group label: Patient with cancer hospitalize inpalliative situation
description: An accurate assessment of the oral condition and proper care will be carried out on day 2 (J2) of hospitalization and repeated on the day of hospital discharge by the nurse detached service, regardless of caregivers.
An assessment of the traceability of clinical assessment and appropriate treatment prescribed or will be conducted on day 3 and repeated the day of the release of hospitalization (or day 15) from information recorded in the patient record
intervention type: Other
intervention name: Evaluation of the oral conditionand proper care
description: An accurate assessment of the oral condition and proper care will be carried out on day 2 (J2) of hospitalization and repeated on the day of hospital discharge by the nurse detached service, regardless of caregivers.
arm group label: Patient with cancer hospitalize inpalliative situation
study pop: 
sampling method: Non-Probability Sample
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: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor