<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/NCT03008993</url>
  </required_header>
  <id_info>
    <org_study_id>HuCare2</org_study_id>
    <nct_id>NCT03008993</nct_id>
  </id_info>
  <brief_title>A Stepped Wedge Cluster Randomized Controlled Trial to Assess a Strategy Aiming to Optimize Psychosocial Outcomes in Patients With Cancer</brief_title>
  <acronym>HuCare2</acronym>
  <official_title>Trial Clinico Controllato e Randomizzato, Con Disegno a Cluster Stepped-wedge, Per Valutare Una Strategia Volta ad Ottimizzare Gli Outcomes Psicosociali in Pazienti Affetti da Cancro</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituti Ospitalieri di Cremona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Azienda Ospedaliero-Universitaria di Parma</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centro di Riferimento Oncologico - Aviano</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Istituto Di Ricerche Farmacologiche Mario Negri</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>IRCCS Sacro Cuore Don Calabria di Negrar</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Arcispedale Santa Maria Nuova-IRCCS</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istituti Ospitalieri di Cremona</source>
  <brief_summary>
    <textblock>
      INTRODUCTION Our group previously demonstrated the feasibility of the Hucare Quality&#xD;
      Improvement Strategy - HQIS, aimed at integrating into practice 6 psychosocial interventions&#xD;
      recommended by international guidelines. This randomized trial is designed to assess whether&#xD;
      the introduction of the strategy in oncology wards improves patient quality of life.&#xD;
&#xD;
      METHODS AND ANALYSIS This is a multicenter, incomplete stepped-wedge cluster randomized&#xD;
      controlled trial, where the intervention strategy is sequentially carried out in three groups&#xD;
      of centers (clusters with 5 centers each) and in three equally spaced time periods (epochs)&#xD;
      (every 4 months). The study also includes an initial epoch during which none of the centers&#xD;
      is exposed to the intervention, and a final epoch when all centers will have implemented the&#xD;
      strategy . The intervention is applied at a cluster level (unit of randomization) and&#xD;
      assessed at an individual level with cross-sectional model. 720 patients will be included,&#xD;
      i.e. 60 patients in each cluster for every detection epoch.&#xD;
&#xD;
      Primary aim is to evaluate the effectiveness of the HQIS vs standard care in terms of&#xD;
      improvement of at least one of two domains of HRQoL using the EORTC QLQ-C30 questionnaire,&#xD;
      detected at baseline and 3 months after enrolment.&#xD;
&#xD;
      The HQIS comprises three phases: 1) clinician training - to improve communication-relational&#xD;
      skills and to instruct on the project; 2) center support - 4 on site visits by experts of the&#xD;
      project team, aimed to introduce the project and boost motivation, instruct staff on how to&#xD;
      implement recommendations, help with context analysis and identification of solutions; assess&#xD;
      actual implementation in the center; 3) implementation of EBM recommendations.&#xD;
&#xD;
      ETHICS AND DISSEMINATION Ethics committee review approval has been obtained from the Ethics&#xD;
      Committee of Parma. Results will be disseminated at conferences, in peer-reviewed and&#xD;
      professional journals intended for policymakers and managers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 17, 2016</start_date>
  <completion_date type="Actual">November 6, 2018</completion_date>
  <primary_completion_date type="Actual">November 6, 2018</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) -C30</measure>
    <time_frame>baseline - 3rd month</time_frame>
    <description>Quality of life, the primary endpoint of the study, will be assessed with the validated Italian version of the EORTC QLQ-C30 questionnaire, specific for patients with cancer . The tool is self-administered, and comprises 30 questions, 24 of which form nine multi-item scales representing the different aspects, or domains, of QoL: a global health status / QoL scale, five functional scales (physical, role, emotional, cognitive and social), and three symptom scales (fatigue, pain, nausea and vomiting), as well as 6 single items assessing additional symptoms (dyspnoea, loss of appetite, insomnia, constipation, diarrhea) and perceived financial impact of the disease.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">762</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Post-Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The HQIS comprises three phases: 1) clinician training - to improve communication-relational skills and to instruct on the project; 2) center support - 4 on site visits by experts of the project team, aimed to introduce the project and boost motivation, instruct staff on how to implement recommendations, help with context analysis and identification of solutions; assess actual implementation in the center; 3) implementation of EBM recommendations.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HQIS implementation</intervention_name>
    <arm_group_label>Post-Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18&#xD;
&#xD;
          -  Diagnosis (histological or cytological) of solid tumor communicated to the patient&#xD;
             within the previous two months&#xD;
&#xD;
          -  About to start a new medical cancer treatment: chemotherapy (IV or oral), molecular&#xD;
             target drugs, hormonal therapy, immunotherapy&#xD;
&#xD;
          -  Expected survival &gt; 3 months&#xD;
&#xD;
          -  Good comprehension of the Italian language&#xD;
&#xD;
          -  Who have read, understood, and signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous chemotherapy or other medical cancer treatment&#xD;
&#xD;
          -  Recruited in a previous epoch of the study (that is, patients can only participate&#xD;
             during one epoch)&#xD;
&#xD;
          -  Currently participating in other trials which imply the completion of Patient Reported&#xD;
             Outcomes (PROs) in the same period&#xD;
&#xD;
          -  Hospitalized&#xD;
&#xD;
          -  Currently receiving psychiatric treatment&#xD;
&#xD;
          -  Affected by mental or psychiatric disorders, due to cancer or coexisting illness,&#xD;
             which interfere with the state of consciousness or impede judgment&#xD;
&#xD;
          -  Inability to complete the questionnaire or ensure participation in the three-month&#xD;
             follow-up&#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>Rodolfo Passalacqua</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istituti Ospitalieri Cremona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Azienda USL- Presidio &quot;Di Summa - Perrino&quot;</name>
      <address>
        <city>Brindisi</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Cosenza</name>
      <address>
        <city>Cosenza</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Ospedali Riuniti Marche Nord</name>
      <address>
        <city>Fano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Policlinico Universitario &quot;G.Martino&quot;</name>
      <address>
        <city>Messina</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Istituto Tumori</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera dei Colli</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Sanitaria Locale</name>
      <address>
        <city>Nuoro</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera &quot;P Giaccone&quot;</name>
      <address>
        <city>Palermo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Ospedali Riuniti Marche Nord</name>
      <address>
        <city>Pesaro</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASL Ospedale SS Annunziata</name>
      <address>
        <city>Sassari</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria &quot;San Luigi Gonzaga&quot;</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Città della Salute e della Scienza</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Sanitaria Provinciale</name>
      <address>
        <city>Trapani</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria di Udine</name>
      <address>
        <city>Udine</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Sacro Cuore &quot;Don Calabria&quot; Presidio ospedaliero accreditato</name>
      <address>
        <city>Verona</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>June 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istituti Ospitalieri di Cremona</investigator_affiliation>
    <investigator_full_name>Rodolfo Passalacqua</investigator_full_name>
    <investigator_title>Head of division</investigator_title>
  </responsible_party>
  <!-- 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/NCT03008993
org study id: HuCare2
nct id: NCT03008993
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
INTRODUCTION Our group previously demonstrated the feasibility of the Hucare Quality
      Improvement Strategy - HQIS, aimed at integrating into practice 6 psychosocial interventions
      recommended by international guidelines. This randomized trial is designed to assess whether
      the introduction of the strategy in oncology wards improves patient quality of life.

      METHODS AND ANALYSIS This is a multicenter, incomplete stepped-wedge cluster randomized
      controlled trial, where the intervention strategy is sequentially carried out in three groups
      of centers (clusters with 5 centers each) and in three equally spaced time periods (epochs)
      (every 4 months). The study also includes an initial epoch during which none of the centers
      is exposed to the intervention, and a final epoch when all centers will have implemented the
      strategy . The intervention is applied at a cluster level (unit of randomization) and
      assessed at an individual level with cross-sectional model. 720 patients will be included,
      i.e. 60 patients in each cluster for every detection epoch.

      Primary aim is to evaluate the effectiveness of the HQIS vs standard care in terms of
      improvement of at least one of two domains of HRQoL using the EORTC QLQ-C30 questionnaire,
      detected at baseline and 3 months after enrolment.

      The HQIS comprises three phases: 1) clinician training - to improve communication-relational
      skills and to instruct on the project; 2) center support - 4 on site visits by experts of the
      project team, aimed to introduce the project and boost motivation, instruct staff on how to
      implement recommendations, help with context analysis and identification of solutions; assess
      actual implementation in the center; 3) implementation of EBM recommendations.

      ETHICS AND DISSEMINATION Ethics committee review approval has been obtained from the Ethics
      Committee of Parma. Results will be disseminated at conferences, in peer-reviewed and
      professional journals intended for policymakers and managers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
measure: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) -C30
time frame: baseline - 3rd month
description: Quality of life, the primary endpoint of the study, will be assessed with the validated Italian version of the EORTC QLQ-C30 questionnaire, specific for patients with cancer . The tool is self-administered, and comprises 30 questions, 24 of which form nine multi-item scales representing the different aspects, or domains, of QoL: a global health status / QoL scale, five functional scales (physical, role, emotional, cognitive and social), and three symptom scales (fatigue, pain, nausea and vomiting), as well as 6 single items assessing additional symptoms (dyspnoea, loss of appetite, insomnia, constipation, diarrhea) and perceived financial impact of the disease.
arm group label: Post-Intervention
arm group type: Experimental
description: The HQIS comprises three phases: 1) clinician training - to improve communication-relational skills and to instruct on the project; 2) center support - 4 on site visits by experts of the project team, aimed to introduce the project and boost motivation, instruct staff on how to implement recommendations, help with context analysis and identification of solutions; assess actual implementation in the center; 3) implementation of EBM recommendations.
arm group label: Control
arm group type: No Intervention
intervention type: Behavioral
intervention name: HQIS implementation
arm group label: Post-Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rodolfo Passalacqua
role: Principal Investigator
affiliation: Istituti Ospitalieri Cremona
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Istituti Ospitalieri di Cremona
investigator full name: Rodolfo Passalacqua
investigator title: Head of division