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/NCT06032975</url>
    </required_header>
    <id_info>
      <org_study_id>MITO 45-ProFFiT</org_study_id>
      <nct_id>NCT06032975</nct_id>
    </id_info>
    <brief_title>PRO for Fighting FT in Ovarian Cancer</brief_title>
    <acronym>MITO45-ProFFiT</acronym>
    <official_title>Patient-Reported Outcome for Fighting Financial Toxicity in Ovarian Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Cancer Institute, Naples</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Cancer Institute, Naples</source>
    <oversight_info>
      <has_dmc>No</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>
        Non-profit, multicenter, prospective, observational study. This study aims to evaluate&#xD;
        whether the articulated treatment algorithm that is now possible for OC patients does produce&#xD;
        tangible changes of financial distress over the time and whether the determinants of&#xD;
        financial distress change their relative weight over the time.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PROFFIT questionnaire is an Italian instrument for evaluating FT in cancer patients in the&#xD;
        Italian healthcare context. It includes 16 total items, 7 measuring FT (defining the PROFFIT&#xD;
        financial score) and 9 measuring possible determinants of FT.The primary aim of the study is&#xD;
        to compare PROFFIT financial score (items 1-7 measuring the financial distress) across&#xD;
        different lines of treatment for OC patients undergoing anticancer medical treatment. Primary&#xD;
        comparison will be based on PROFFIT questionnaire fulfilled at baseline, before starting each&#xD;
        line of treatment.&#xD;
  &#xD;
        In addition, among secondary aims of this study, we aim to verify whether FT is associated&#xD;
        with quality of life response (items 29-30 of the EORTC QLQ-C30 questionnaire and items 55-56&#xD;
        of the EORTC QLQ-OV28 questionnaire), with patient-self reporting toxicity of treatments&#xD;
        (selected symptoms of the PRO-CTCAE library response), and with overall survival.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2026</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>Financial Toxicity &quot;PROFFIT financial score&quot;</measure>
      <time_frame>baseline visit, at the end of every cycle of treatment (each cycle is 21 or 28 days depending of type of therapy), and at time of progressive disease (PD) per RECIST 1.1 up to 36 months</time_frame>
      <description>PROFFIT financial score is defined according to items 1-7 of the PROFFIT questionnaire. It will be calculated according to published rules (Riva S, et al. BMJ Open. 2019 Sep;9(9):e031485).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Financial toxicity &quot;Determinants&quot;</measure>
      <time_frame>baseline visit, at the end of every cycle of treatment (each cycle is 21 or 28 days depending of type of therapy), and at time of progressive disease (PD) per RECIST 1.1 up to 36 months.</time_frame>
      <description>The baseline score for determinants (items 8-16) and their change during treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes of PROFFIT financial score</measure>
      <time_frame>baseline visit, at the end of every cycle of treatment (each cycle is 21 or 28 days depending of type of therapy), and at time of progressive disease (PD) per RECIST 1.1 up to 36 months</time_frame>
      <description>Changes of PROFFIT financial score (items 1-7) from baseline during treatment, will be assessed as secondary endpoints.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life (QoL)</measure>
      <time_frame>baseline visit, at the end of every cycle of treatment (each cycle is 21 or 28 days depending of type of therapy), and at time of progressive disease (PD) per RECIST 1.1 up to 36 months</time_frame>
      <description>QoL will be assessed as secondary endpoint using selected QoL items (items 29-30 of the EORTC QLQ-C30 questionnaire, items 55-56 of the EORTC QLQ-OV28 questionnaire) and selected symptoms of the PRO-CTCAE library.</description>
    </secondary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">240</enrollment>
    <condition>Ovarian Cancer</condition>
    <arm_group>
      <arm_group_label>Cohort 1:</arm_group_label>
      <description>Patients undergoing their first medical treatment for OC (including adjuvant and neo-adjuvant chemotherapy and first-line treatment for advanced in patients not previously treated with adjuvant chemotherapy)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2</arm_group_label>
      <description>Patients undergoing their second medical treatment for OC (including the second-line treatment for advanced disease and the first-line treatment for advanced disease in patients previously treated with adjuvant CT)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 3</arm_group_label>
      <description>Patients undergoing their third medical treatment for OC (including the third-line treatment for advanced disease and the second-line treatment for advanced disease in patients previously treated with adjuvant CT)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 4</arm_group_label>
      <description>Patients undergoing their fourth medical treatment for OC (including the fourth- treatment for advanced disease and the third-line treatment for advanced disease in patients previously treated with adjuvant CT)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaires</intervention_name>
      <description>The PROFFIT questionnaire is a PRO instrument composed by 16 items encompassing all the major life domains where FT can be expressed and is formed by two type of items: (1) outcome (items 1-7) and (2) determinants (items 8-16); EORTC QLQ-C30 questionnaire (items 29-30) and OV28 (items 55-58); PRO-CTCAE: short list of 43 symptoms relevant for ovarian cancer</description>
      <arm_group_label>Cohort 1:</arm_group_label>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_label>Cohort 3</arm_group_label>
      <arm_group_label>Cohort 4</arm_group_label>
      <other_name>Questionnaires: PROFFIT, EORTC QLQ-C30 questionnaire (items 29-30), EORTC OV28 (items 55-58), PRO-CTCAE</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with OC candidate to medical treatment (see cohorts definition).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Written informed consent provided;&#xD;
  &#xD;
            -  Women ≥18 years;&#xD;
  &#xD;
            -  Histologically or citologically confirmed diagnosis of epithelial ovarian, fallopian&#xD;
               tube or peritoneal cancer stage IC-IV according to FIGO staging system;&#xD;
  &#xD;
            -  Patients who are close to begin any type of medical treatment against ovarian cancer.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Major cognitive dysfunction or psychiatric disorders;&#xD;
  &#xD;
            -  Patients with epithelial ovarian, fallopian tube or peritoneal cancer candidate&#xD;
               exclusively to follow-up;&#xD;
  &#xD;
            -  Patients who have received more than 4 previous lines of medical treatment&#xD;
               (maintenance treatments do not represent a line).&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Ovarian cancer patients</gender_description>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sandro Pignata, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Cancer Institute, Naples</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Clorinda Schettino, MD</last_name>
      <phone>+39 081 - 17770276</phone>
      <email>c.schettino@istitutotumori.na.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Piera Gargiulo, MD</last_name>
      <phone>+39 081 - 17770276</phone>
      <email>piera.gargiulo@istitutotumori.na.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Nation Cancer Institute of Naples, Division of Medical Oncology - Uro-Gynecology Department</name>
        <address>
          <city>Naples</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Sandro Pignata, MD, PhD</last_name>
        <phone>+39 081-17770755</phone>
        <email>s.pignata@istitutotumori.na.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Ovarian cancer</keyword>
    <keyword>Financial Toxicity</keyword>
    <keyword>Quality of life</keyword>
    <keyword>PROFFIT questionnaire</keyword>
    <keyword>PRO-CTCAE</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ovarian Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Ovarian Epithelial</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/NCT06032975
  org study id: MITO 45-ProFFiT
  nct id: NCT06032975
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Non-profit, multicenter, prospective, observational study. This study aims to evaluate
        whether the articulated treatment algorithm that is now possible for OC patients does produce
        tangible changes of financial distress over the time and whether the determinants of
        financial distress change their relative weight over the time.
  PROFFIT questionnaire is an Italian instrument for evaluating FT in cancer patients in the
        Italian healthcare context. It includes 16 total items, 7 measuring FT (defining the PROFFIT
        financial score) and 9 measuring possible determinants of FT.The primary aim of the study is
        to compare PROFFIT financial score (items 1-7 measuring the financial distress) across
        different lines of treatment for OC patients undergoing anticancer medical treatment. Primary
        comparison will be based on PROFFIT questionnaire fulfilled at baseline, before starting each
        line of treatment.
  
        In addition, among secondary aims of this study, we aim to verify whether FT is associated
        with quality of life response (items 29-30 of the EORTC QLQ-C30 questionnaire and items 55-56
        of the EORTC QLQ-OV28 questionnaire), with patient-self reporting toxicity of treatments
        (selected symptoms of the PRO-CTCAE library response), and with overall survival.
  observational model: Cohort
  time perspective: Prospective
  measure: Financial Toxicity "PROFFIT financial score"
  time frame: baseline visit, at the end of every cycle of treatment (each cycle is 21 or 28 days depending of type of therapy), and at time of progressive disease (PD) per RECIST 1.1 up to 36 months
  description: PROFFIT financial score is defined according to items 1-7 of the PROFFIT questionnaire. It will be calculated according to published rules (Riva S, et al. BMJ Open. 2019 Sep;9(9):e031485).
  measure: Financial toxicity "Determinants"
  time frame: baseline visit, at the end of every cycle of treatment (each cycle is 21 or 28 days depending of type of therapy), and at time of progressive disease (PD) per RECIST 1.1 up to 36 months.
  description: The baseline score for determinants (items 8-16) and their change during treatment
  measure: Changes of PROFFIT financial score
  time frame: baseline visit, at the end of every cycle of treatment (each cycle is 21 or 28 days depending of type of therapy), and at time of progressive disease (PD) per RECIST 1.1 up to 36 months
  description: Changes of PROFFIT financial score (items 1-7) from baseline during treatment, will be assessed as secondary endpoints.
  measure: Quality of Life (QoL)
  time frame: baseline visit, at the end of every cycle of treatment (each cycle is 21 or 28 days depending of type of therapy), and at time of progressive disease (PD) per RECIST 1.1 up to 36 months
  description: QoL will be assessed as secondary endpoint using selected QoL items (items 29-30 of the EORTC QLQ-C30 questionnaire, items 55-56 of the EORTC QLQ-OV28 questionnaire) and selected symptoms of the PRO-CTCAE library.
  arm group label: Cohort 1:
  description: Patients undergoing their first medical treatment for OC (including adjuvant and neo-adjuvant chemotherapy and first-line treatment for advanced in patients not previously treated with adjuvant chemotherapy)
  arm group label: Cohort 2
  description: Patients undergoing their second medical treatment for OC (including the second-line treatment for advanced disease and the first-line treatment for advanced disease in patients previously treated with adjuvant CT)
  arm group label: Cohort 3
  description: Patients undergoing their third medical treatment for OC (including the third-line treatment for advanced disease and the second-line treatment for advanced disease in patients previously treated with adjuvant CT)
  arm group label: Cohort 4
  description: Patients undergoing their fourth medical treatment for OC (including the fourth- treatment for advanced disease and the third-line treatment for advanced disease in patients previously treated with adjuvant CT)
  intervention type: Other
  intervention name: Questionnaires
  description: The PROFFIT questionnaire is a PRO instrument composed by 16 items encompassing all the major life domains where FT can be expressed and is formed by two type of items: (1) outcome (items 1-7) and (2) determinants (items 8-16); EORTC QLQ-C30 questionnaire (items 29-30) and OV28 (items 55-58); PRO-CTCAE: short list of 43 symptoms relevant for ovarian cancer
  arm group label: Cohort 1:
  arm group label: Cohort 2
  arm group label: Cohort 3
  arm group label: Cohort 4
  other name: Questionnaires: PROFFIT, EORTC QLQ-C30 questionnaire (items 29-30), EORTC OV28 (items 55-58), PRO-CTCAE
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Ovarian cancer patients
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Sandro Pignata, MD, PhD
  role: Principal Investigator
  affiliation: National Cancer Institute, Naples
  last name: Clorinda Schettino, MD
  phone: +39 081 - 17770276
  email: c.schettino@istitutotumori.na.it
  last name: Piera Gargiulo, MD
  phone: +39 081 - 17770276
  email: piera.gargiulo@istitutotumori.na.it
  facility: 
  contact: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Ovarian Neoplasms
  mesh term: Carcinoma, Ovarian Epithelial
  sharing ipd: Undecided