xml: <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/NCT06035731</url>
    </required_header>
    <id_info>
      <org_study_id>RIHP-CHV-13</org_study_id>
      <nct_id>NCT06035731</nct_id>
    </id_info>
    <brief_title>Evaluation of the Medical Service by Socio-aesthetics in Oncology</brief_title>
    <acronym>RCT-SE</acronym>
    <official_title>Evaluation of the Medical Service by Socio-aesthetics in Oncology</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier de Valence</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier de Valence</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        the 3-year randomized controlled RCT-SE study aims to investigate Socio-aesthetics well being&#xD;
        care on quality of life, pain and anxiety.&#xD;
  &#xD;
        The primary objective is to show that socio-aesthetics well being care improves quality of&#xD;
        life during cancer treatment, compared to self care administration of dermo-cosmetics&#xD;
        products&#xD;
  &#xD;
        The secondary objectives are to show that socio-aesthetics well being care significantly&#xD;
        reduced anxiety and pain compared to self care administration of dermo-cosmetics products&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Socio-aesthetics care is the delivery appropriate beauty care in a population weakened by a&#xD;
        physical, psychological and/or social attack.&#xD;
  &#xD;
        this well-being care is imperfectly assessed with few data from randomized controlled trials.&#xD;
  &#xD;
        The RCT-STudy is a randomized, controlled, multicenter, open label, intervention study that&#xD;
        will be conducted among 400 patients treated with chemotherapy for breast, prostate, colon&#xD;
        and lung cancer.&#xD;
  &#xD;
        Patients will be randomly assigned to one of the two arms of the study according to a 1:1&#xD;
        ratio:&#xD;
  &#xD;
          -  Group A will benefit from 4 sessions of well being care performed by a qualified&#xD;
             socio-aesthetic person, with dermo-cosmetics product defined, during 4 consecutive&#xD;
             chemotherapy administrations .&#xD;
  &#xD;
          -  Group B (control) will apply the same dermo-cosmetics products themselves (self-care)&#xD;
             without intervention of socio-aesthetic, during 4 consecutive chemotherapy&#xD;
             administrations&#xD;
  &#xD;
             12 Evaluations will be conducted between chemotherapy cure N° 2 and chemotherapy cure&#xD;
             N°5:&#xD;
  &#xD;
          -  Pain assessed by Eva&#xD;
  &#xD;
          -  Anxiety assessed by HADS&#xD;
  &#xD;
          -  impact of socio-aesthetics care care , assessed by Patient Centricity Questionnaire&#xD;
             (PCQ) (0 -110)&#xD;
  &#xD;
        Data will be recorded using an e-CRF. patient will be recruited over 3 years and will be&#xD;
        followed up for 3 months.&#xD;
  &#xD;
        Hypothesis:&#xD;
  &#xD;
        Socio-aesthetics session significantly improves quality of life and reduced pain and anxiety&#xD;
        compared to self care administration of dermo-cosmetics products&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">April 2027</completion_date>
    <primary_completion_date type="Anticipated">November 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>open label, randomized, controlled, multicenter intervention study</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patient Centricity Questionnaire (PCQ): Patient reported outcome: impact of supportive care</measure>
      <time_frame>up to 12 weeks</time_frame>
      <description>Patient Centricity Questionnaire (PCQ): (0-110) higher scores mean better outcome</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>pain EVA</measure>
      <time_frame>up to 12 weeks</time_frame>
      <description>EVA (0-10) higher scores mean worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety</measure>
      <time_frame>up to 12 weeks</time_frame>
      <description>HADS: Hospital Anxiety and Depression Scale (0-42) higher scores mean worse outcome.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Cancer of Colon</condition>
    <condition>Cancer, Lung</condition>
    <condition>Cancer, Breast</condition>
    <condition>Cancer Prostate</condition>
    <condition>Cancer Pain</condition>
    <condition>Anxiety Depression</condition>
    <arm_group>
      <arm_group_label>group A: well-being care performed by SOCIO-AESTHETICS</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group A will benefit from 4 sessions of well being care performed by a qualified socio-aesthetics, during 4 consecutive chemotherapy administrations.&#xD;
  Patients included will have following interventions :&#xD;
  quality of life: PCQ Pain: EVA Anxiety: HADS</description>
    </arm_group>
    <arm_group>
      <arm_group_label>group B: control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Group B (control) will apply the dermo-cosmetic products themselves (self-care) without intervention of the socio-aesthetician, during 4 consecutive chemotherapy administrations.&#xD;
  quality of life: PCQ Pain: EVA Anxiety: HADS</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>SOCIO-AESTHETICS care</intervention_name>
      <description>SOCIO-AESTHETICS well being care performed by qualify person</description>
      <arm_group_label>group A: well-being care performed by SOCIO-AESTHETICS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  over 18 years old&#xD;
  &#xD;
            -  treated with chemotherapy for lung , breast, colon or prostate cancer&#xD;
  &#xD;
            -  Able to understand, read, and write French,&#xD;
  &#xD;
            -  Affiliated with a social security scheme,&#xD;
  &#xD;
            -  Having dated and signed an informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to be followed for medical, social, family, geographic or psychological reasons&#xD;
               for the duration of the study,&#xD;
  &#xD;
            -  Deprived of their liberty by court or administrative decision,&#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>Guillaume Guillaume</last_name>
      <role>Principal Investigator</role>
      <affiliation>CH Valence</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Guillaume Guillaume</last_name>
      <phone>+33475752555</phone>
      <email>gbuiret@ch-valence.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>sandrine Beauchard, MD</last_name>
      <phone>+33475818870</phone>
      <email>sbeauchard@ch-valence.fr</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>SOCIO-AESTHETIC</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
      <mesh_term>Lung Neoplasms</mesh_term>
      <mesh_term>Colonic Neoplasms</mesh_term>
      <mesh_term>Cancer Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035731
  org study id: RIHP-CHV-13
  nct id: NCT06035731
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  the 3-year randomized controlled RCT-SE study aims to investigate Socio-aesthetics well being
        care on quality of life, pain and anxiety.
  
        The primary objective is to show that socio-aesthetics well being care improves quality of
        life during cancer treatment, compared to self care administration of dermo-cosmetics
        products
  
        The secondary objectives are to show that socio-aesthetics well being care significantly
        reduced anxiety and pain compared to self care administration of dermo-cosmetics products
  Socio-aesthetics care is the delivery appropriate beauty care in a population weakened by a
        physical, psychological and/or social attack.
  
        this well-being care is imperfectly assessed with few data from randomized controlled trials.
  
        The RCT-STudy is a randomized, controlled, multicenter, open label, intervention study that
        will be conducted among 400 patients treated with chemotherapy for breast, prostate, colon
        and lung cancer.
  
        Patients will be randomly assigned to one of the two arms of the study according to a 1:1
        ratio:
  
          -  Group A will benefit from 4 sessions of well being care performed by a qualified
             socio-aesthetic person, with dermo-cosmetics product defined, during 4 consecutive
             chemotherapy administrations .
  
          -  Group B (control) will apply the same dermo-cosmetics products themselves (self-care)
             without intervention of socio-aesthetic, during 4 consecutive chemotherapy
             administrations
  
             12 Evaluations will be conducted between chemotherapy cure N° 2 and chemotherapy cure
             N°5:
  
          -  Pain assessed by Eva
  
          -  Anxiety assessed by HADS
  
          -  impact of socio-aesthetics care care , assessed by Patient Centricity Questionnaire
             (PCQ) (0 -110)
  
        Data will be recorded using an e-CRF. patient will be recruited over 3 years and will be
        followed up for 3 months.
  
        Hypothesis:
  
        Socio-aesthetics session significantly improves quality of life and reduced pain and anxiety
        compared to self care administration of dermo-cosmetics products
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: open label, randomized, controlled, multicenter intervention study
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Patient Centricity Questionnaire (PCQ): Patient reported outcome: impact of supportive care
  time frame: up to 12 weeks
  description: Patient Centricity Questionnaire (PCQ): (0-110) higher scores mean better outcome
  measure: pain EVA
  time frame: up to 12 weeks
  description: EVA (0-10) higher scores mean worse outcome.
  measure: Anxiety
  time frame: up to 12 weeks
  description: HADS: Hospital Anxiety and Depression Scale (0-42) higher scores mean worse outcome.
  arm group label: group A: well-being care performed by SOCIO-AESTHETICS
  arm group type: Experimental
  description: Group A will benefit from 4 sessions of well being care performed by a qualified socio-aesthetics, during 4 consecutive chemotherapy administrations.
  Patients included will have following interventions :
  quality of life: PCQ Pain: EVA Anxiety: HADS
  arm group label: group B: control
  arm group type: No Intervention
  description: Group B (control) will apply the dermo-cosmetic products themselves (self-care) without intervention of the socio-aesthetician, during 4 consecutive chemotherapy administrations.
  quality of life: PCQ Pain: EVA Anxiety: HADS
  intervention type: Other
  intervention name: SOCIO-AESTHETICS care
  description: SOCIO-AESTHETICS well being care performed by qualify person
  arm group label: group A: well-being care performed by SOCIO-AESTHETICS
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Guillaume Guillaume
  role: Principal Investigator
  affiliation: CH Valence
  last name: Guillaume Guillaume
  phone: +33475752555
  email: gbuiret@ch-valence.fr
  last name: sandrine Beauchard, MD
  phone: +33475818870
  email: sbeauchard@ch-valence.fr
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  mesh term: Lung Neoplasms
  mesh term: Colonic Neoplasms
  mesh term: Cancer Pain
  sharing ipd: Undecided