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/NCT06037213</url>
    </required_header>
    <id_info>
      <org_study_id>PekingUMCH-PRO1</org_study_id>
      <nct_id>NCT06037213</nct_id>
    </id_info>
    <brief_title>A Real-World Patient-Reported Outcomes Study in Patients With Long-Term Use of Niraparib</brief_title>
    <official_title>Non-interventional Study to Collect Real-world Patient-Reported Outcomes Data in Platinum-Sensitive Relapsed Ovarian Cancer Patients With Long-Term Use of Niraparib</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College Hospital</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This prospective, non-interventional study is designed to evaluate the quality of life of&#xD;
        Chinese ovarian cancer patients with long-term niraparib use in a real-world setting.&#xD;
        Participants will complete questionnaires or accept telephone follow-up to provide&#xD;
        information about their quality of life.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this prospective, non-interventional study, patients with platinum-sensitive relapsed&#xD;
        ovarian cancer who have received niraparib as maintenance therapy for more than two years&#xD;
        will agree to be contacted by questionnaire or telephone three times. The interval will be&#xD;
        4-6 weeks. Information on quality of life will be collected and analysed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 23, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Patient-reported health-related quality of life (HRQoL) - EQ-5D-5L questionnaire</measure>
      <time_frame>4 months</time_frame>
      <description>The EQ-5D is a standardized measure of health status applicable to a wide range of health conditions and treatments designed by the EuroQoL Group (EQ). It consists of the EQ-5D-5L descriptive system, which comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with each dimension having 5 levels (5L), and the EQ visual analogue scale (EQ VAS)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient-reported health-related quality of life (HRQoL) - FOSI questionnaire</measure>
      <time_frame>4 months</time_frame>
      <description>The FOSI (Functional Assessment of Cancer Therapy-Ovarian Symptom Index) is a validated tool with eight items that measure response to treatment based on symptom assessment. The questions assess pain, fatigue, nausea, vomiting, bloating, cramping, worry, and QoL. Patients report their symptoms over the past week using a five-point Likert scale, which ranges from 0 (not at all) to 4 (very much).</description>
    </primary_outcome>
    <other_outcome>
      <measure>Patient population checklist</measure>
      <time_frame>at baseline</time_frame>
      <description>Baseline characteristics, disease history, comorbidities and concomitant treatments, education.</description>
    </other_outcome>
    <other_outcome>
      <measure>Niraparib medication checklist</measure>
      <time_frame>at baseline</time_frame>
      <description>Starting dose, dose modification.</description>
    </other_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Ovarian Cancer</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients are members of the patient assistance programme population.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥18 years&#xD;
  &#xD;
            -  Histologically confirmed platinum-sensitive recurrent epithelial ovarian, fallopian&#xD;
               tube or primary peritoneal cancer&#xD;
  &#xD;
            -  Maintenance treatment with niraparib for ≥2 years and continuing for the next 28 days&#xD;
  &#xD;
            -  No significant cognitive impairment&#xD;
  &#xD;
            -  Understand the trial procedure and be able to sign the informed consent form before&#xD;
               any study-related procedures&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who are not suitable for participation in this study according to the&#xD;
               investigator's evaluation&#xD;
  &#xD;
            -  Patients receiving antineoplastic drugs for other malignancies&#xD;
  &#xD;
            -  Patients who are unable to comply with the protocol procedures&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>female</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yang Xiang, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking Union Medical College Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Peng Peng, MD.</last_name>
      <phone>+86-13521361934</phone>
      <email>pengp1999@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100032</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Peng Peng, MD.</last_name>
        <phone>+86-13521361934</phone>
        <email>pengp1999@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 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>patient-reported outcomes</keyword>
    <keyword>niraparib</keyword>
    <keyword>real-world</keyword>
    <keyword>ovarian cancer</keyword>
    <keyword>quality of life</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>No</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/NCT06037213
  org study id: PekingUMCH-PRO1
  nct id: NCT06037213
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This prospective, non-interventional study is designed to evaluate the quality of life of
        Chinese ovarian cancer patients with long-term niraparib use in a real-world setting.
        Participants will complete questionnaires or accept telephone follow-up to provide
        information about their quality of life.
  In this prospective, non-interventional study, patients with platinum-sensitive relapsed
        ovarian cancer who have received niraparib as maintenance therapy for more than two years
        will agree to be contacted by questionnaire or telephone three times. The interval will be
        4-6 weeks. Information on quality of life will be collected and analysed.
  observational model: Cohort
  time perspective: Prospective
  measure: Patient-reported health-related quality of life (HRQoL) - EQ-5D-5L questionnaire
  time frame: 4 months
  description: The EQ-5D is a standardized measure of health status applicable to a wide range of health conditions and treatments designed by the EuroQoL Group (EQ). It consists of the EQ-5D-5L descriptive system, which comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with each dimension having 5 levels (5L), and the EQ visual analogue scale (EQ VAS)
  measure: Patient-reported health-related quality of life (HRQoL) - FOSI questionnaire
  time frame: 4 months
  description: The FOSI (Functional Assessment of Cancer Therapy-Ovarian Symptom Index) is a validated tool with eight items that measure response to treatment based on symptom assessment. The questions assess pain, fatigue, nausea, vomiting, bloating, cramping, worry, and QoL. Patients report their symptoms over the past week using a five-point Likert scale, which ranges from 0 (not at all) to 4 (very much).
  measure: Patient population checklist
  time frame: at baseline
  description: Baseline characteristics, disease history, comorbidities and concomitant treatments, education.
  measure: Niraparib medication checklist
  time frame: at baseline
  description: Starting dose, dose modification.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yang Xiang, MD.
  role: Principal Investigator
  affiliation: Peking Union Medical College Hospital
  last name: Peng Peng, MD.
  phone: +86-13521361934
  email: pengp1999@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Ovarian Neoplasms
  mesh term: Carcinoma, Ovarian Epithelial
  sharing ipd: No