<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/NCT04439461</url>
  </required_header>
  <id_info>
    <org_study_id>CS-VR-ONCO_MFR_2020</org_study_id>
    <nct_id>NCT04439461</nct_id>
  </id_info>
  <brief_title>Adaptation and First Step Validation of the ICF Core Set for Vocational Rehabilitation for Cancer Survivors</brief_title>
  <official_title>Adaptation and First Step Validation of the International Classification of Functioning, Disability and Health Core Set for Vocational Rehabilitation for Cancer Survivors: A Sequential Mixed Method Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Unità Sanitaria Locale Reggio Emilia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Unità Sanitaria Locale Reggio Emilia</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>
      Return to work (RTW) of cancer survivors (CSs) is an emerging health issue, as cancer&#xD;
      incidence, survival rate and prevalent cases have increasing trends and more than 1/3 of CSs&#xD;
      are in their working age.&#xD;
&#xD;
      Starting from the International Classification of Functioning, Disability and Health (ICF),&#xD;
      the Core Set for Vocational Rehabilitation (CS-VR) has been developed to comprehensively&#xD;
      describe work functioning of individuals reporting difficulties and in need of VR. The CS-VR&#xD;
      guides the multidisciplinary assessment of individuals and the planning of appropriate VR&#xD;
      interventions but, to date, it has been tested only in spinal cord injury and musculoskeletal&#xD;
      diseases. Thus, verifying the appropriateness of the CS-VR in a population of cancer&#xD;
      survivors seems a step forward.&#xD;
&#xD;
      This sequential mixed method study aims to adapt and validate the CS-VR in Italian cancer&#xD;
      survivors, defining the minimum standard of work functioning areas to assess in this&#xD;
      population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Starting from the CS-VR, this study aims to define the CS-VR-Onco, an ICF core set consistent&#xD;
      with cancer survivors' needs.&#xD;
&#xD;
      CS-VR-Onco will guide professionals in:&#xD;
&#xD;
        1. comprehensively assessing work functioning&#xD;
&#xD;
        2. identifying the areas of work functioning in which the VR intervention is relevant&#xD;
&#xD;
        3. identifying patients who would benefit most from VR&#xD;
&#xD;
        4. measuring work functioning pre-post VR&#xD;
&#xD;
      This sequential exploratory design involves multiple phases of qualitative (phase 1) and&#xD;
      quantitative (phase 2) data collection.&#xD;
&#xD;
      Qualitative_phase 1, To adapt the CS-VR: 1.a_Focus groups (FGs) will be organized with CSs&#xD;
      selected from the UNAMANO project (NCT03666936), the Cancer Registry of Reggio Emilia, the&#xD;
      General Practitioners of the province of Reggio Emilia and the voluntary non-profit&#xD;
      associations of cancer patients. During the FGs, we will ask participants to name and reflect&#xD;
      on barriers and facilitators influencing their RTW process. Further, the FGs will address&#xD;
      those ICF components from which the CS-VR categories were extracted. 1.b_Consensus-based&#xD;
      approach with a sample of stakeholders of the RTW process. We will integrate evidence&#xD;
      gathered from phase 1.a and the literature to develop the minimum standard for the assessment&#xD;
      of work functioning in this population (CS-VR-Onco).&#xD;
&#xD;
      Quantitative_phase 2, To validate the CS-VR-Onco: 2.a_Cross-sectional survey of CSs extracted&#xD;
      from the Cancer Registry of Reggio Emilia. Through a guided interview based on the categories&#xD;
      of the CS-VR-Onco, we will ask participants to report their work difficulties.&#xD;
      2.b_Longitudinal study on cancer patients recently diagnosed with cancer referred to UNAMANO&#xD;
      project for VR. Before and after the VR, CS-VR-Onco will be administer to identify patients'&#xD;
      needs. Additionally, participants will be assessed with valid measurement tools (when&#xD;
      present) pertinent to the CS-VR-Onco categories identified.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 9, 2020</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Actual">June 18, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>1.a_Focus group</measure>
    <time_frame>3 months</time_frame>
    <description>To obtain the preliminary CS-VR-Onco, which categories will be subsequently analyzed by the group of stakeholders.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>1.b_Consensus-based approach</measure>
    <time_frame>3 months</time_frame>
    <description>To obtain the CS-VR-Onco, that is representative of minimum standard of work functioning areas to be assessed in cancer survivors in working age.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>2.a_Cross-sectional survey</measure>
    <time_frame>12 months</time_frame>
    <description>To describe the frequency of distribution of the categories included in the CS-VR-Onco (content validity) and to compare those distributions between CSs who did and those who did not experience difficulties in the RTW process (construct validity).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2.b_Longitudinal study</measure>
    <time_frame>12 months</time_frame>
    <description>To verify whether the CS-VR-Onco can appropriately identify the categories in which VR is of main relevance and detect changes over time.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">164</enrollment>
  <condition>Cancer Survivors</condition>
  <eligibility>
    <study_pop>
      <textblock>
        1.a Focus Group: CSs will be recruited if the eligibility criteria reported below are&#xD;
        satisfied. The Cancer Registry of Reggio Emilia will recruit CSs diagnosed in 2017 and who&#xD;
        have already returned to work. 1.b Consensus-based approach: stakeholders (healthcare&#xD;
        professionals, social workers, CSs, caregivers, employers, nonprofit associations,&#xD;
        vocational counsellors, etc.) who handle the RTW process of CSs will be invited to&#xD;
        participate. 2.a Cross-sectional study: CSs will be recruited if the eligibility criteria&#xD;
        reported below are satisfied and diagnosis occurred in 2018. 2.b Longitudinal study:&#xD;
        participants will be recruited if the eligibility criteria reported below are satisfied and&#xD;
        cancer patients will be referred to UNAMANO for VR.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        1. Inclusion Criteria:&#xD;
&#xD;
               -  cancer diagnosis&#xD;
&#xD;
               -  CSs employed at diagnosis&#xD;
&#xD;
             Exclusion Criteria:&#xD;
&#xD;
               -  comorbidities that limit communication or collaboration (i.e., aphasia, dementia,&#xD;
                  etc.)&#xD;
&#xD;
               -  non-melanoma skin cancer&#xD;
&#xD;
          2. Inclusion Criteria: Stakeholders who handle the RTW process: healthcare professionals,&#xD;
             social workers, CSs, caregivers, employers, nonprofit associations, vocational&#xD;
             counsellors, etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sara Paltrinieri, Msc OT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Unità Sanitaria Locale Reggio Emilia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sara Paltrinieri, Msc OT</last_name>
    <phone>00390522522416</phone>
    <email>sara.paltrinieri@ausl.re.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stefania Costi, PhD</last_name>
    <phone>00390522522441</phone>
    <email>stefania.costi@unimore.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Azienda Unità Sanitaria Locale Reggio Emilia</name>
      <address>
        <city>Reggio Emilia</city>
        <zip>42123</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sara Paltrinieri, BSc OT</last_name>
      <phone>00390522522416</phone>
      <email>sara.paltrinieri@ausl.re.it</email>
    </contact>
    <contact_backup>
      <last_name>Stefania Costi, PhD</last_name>
      <phone>00390522522441</phone>
      <email>stefania.costi@unimore.it</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 27, 2023</last_update_submitted>
  <last_update_submitted_qc>June 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Unità Sanitaria Locale Reggio Emilia</investigator_affiliation>
    <investigator_full_name>Sara Paltrinieri</investigator_full_name>
    <investigator_title>MSc Occupational Therapist</investigator_title>
  </responsible_party>
  <keyword>Vocational Rehabilitation</keyword>
  <keyword>International Classification of Functioning, Disability and Health</keyword>
  <keyword>Return to Work</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/NCT04439461
org study id: CS-VR-ONCO_MFR_2020
nct id: NCT04439461
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Return to work (RTW) of cancer survivors (CSs) is an emerging health issue, as cancer
      incidence, survival rate and prevalent cases have increasing trends and more than 1/3 of CSs
      are in their working age.

      Starting from the International Classification of Functioning, Disability and Health (ICF),
      the Core Set for Vocational Rehabilitation (CS-VR) has been developed to comprehensively
      describe work functioning of individuals reporting difficulties and in need of VR. The CS-VR
      guides the multidisciplinary assessment of individuals and the planning of appropriate VR
      interventions but, to date, it has been tested only in spinal cord injury and musculoskeletal
      diseases. Thus, verifying the appropriateness of the CS-VR in a population of cancer
      survivors seems a step forward.

      This sequential mixed method study aims to adapt and validate the CS-VR in Italian cancer
      survivors, defining the minimum standard of work functioning areas to assess in this
      population.
Starting from the CS-VR, this study aims to define the CS-VR-Onco, an ICF core set consistent
      with cancer survivors' needs.

      CS-VR-Onco will guide professionals in:

        1. comprehensively assessing work functioning

        2. identifying the areas of work functioning in which the VR intervention is relevant

        3. identifying patients who would benefit most from VR

        4. measuring work functioning pre-post VR

      This sequential exploratory design involves multiple phases of qualitative (phase 1) and
      quantitative (phase 2) data collection.

      Qualitative_phase 1, To adapt the CS-VR: 1.a_Focus groups (FGs) will be organized with CSs
      selected from the UNAMANO project (NCT03666936), the Cancer Registry of Reggio Emilia, the
      General Practitioners of the province of Reggio Emilia and the voluntary non-profit
      associations of cancer patients. During the FGs, we will ask participants to name and reflect
      on barriers and facilitators influencing their RTW process. Further, the FGs will address
      those ICF components from which the CS-VR categories were extracted. 1.b_Consensus-based
      approach with a sample of stakeholders of the RTW process. We will integrate evidence
      gathered from phase 1.a and the literature to develop the minimum standard for the assessment
      of work functioning in this population (CS-VR-Onco).

      Quantitative_phase 2, To validate the CS-VR-Onco: 2.a_Cross-sectional survey of CSs extracted
      from the Cancer Registry of Reggio Emilia. Through a guided interview based on the categories
      of the CS-VR-Onco, we will ask participants to report their work difficulties.
      2.b_Longitudinal study on cancer patients recently diagnosed with cancer referred to UNAMANO
      project for VR. Before and after the VR, CS-VR-Onco will be administer to identify patients'
      needs. Additionally, participants will be assessed with valid measurement tools (when
      present) pertinent to the CS-VR-Onco categories identified.
observational model: Other
time perspective: Other
measure: 1.a_Focus group
time frame: 3 months
description: To obtain the preliminary CS-VR-Onco, which categories will be subsequently analyzed by the group of stakeholders.
measure: 1.b_Consensus-based approach
time frame: 3 months
description: To obtain the CS-VR-Onco, that is representative of minimum standard of work functioning areas to be assessed in cancer survivors in working age.
measure: 2.a_Cross-sectional survey
time frame: 12 months
description: To describe the frequency of distribution of the categories included in the CS-VR-Onco (content validity) and to compare those distributions between CSs who did and those who did not experience difficulties in the RTW process (construct validity).
measure: 2.b_Longitudinal study
time frame: 12 months
description: To verify whether the CS-VR-Onco can appropriately identify the categories in which VR is of main relevance and detect changes over time.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sara Paltrinieri, Msc OT
role: Principal Investigator
affiliation: Azienda Unità Sanitaria Locale Reggio Emilia
last name: Sara Paltrinieri, Msc OT
phone: 00390522522416
email: sara.paltrinieri@ausl.re.it
last name: Stefania Costi, PhD
phone: 00390522522441
email: stefania.costi@unimore.it
facility: 
status: Recruiting
contact: 
contact backup: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda Unità Sanitaria Locale Reggio Emilia
investigator full name: Sara Paltrinieri
investigator title: MSc Occupational Therapist