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/NCT05964816</url>
    </required_header>
    <id_info>
      <org_study_id>YKuang</org_study_id>
      <nct_id>NCT05964816</nct_id>
    </id_info>
    <brief_title>A Longitudinal Study of the Trajectory of Financial Toxicity and Its Relationship With Symptom Burden in Breast Cancer Patients</brief_title>
    <official_title>A Longitudinal Study of the Trajectory of Financial Toxicity and Its Relationship With Symptom Burden in Breast Cancer Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fudan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fudan University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Breast cancer has become the leading cause of global cancer incidence. With the improvement&#xD;
        of treatment methods, some breast cancer patients have experienced different degrees of&#xD;
        financial toxicity, which seriously affected the quality of life, treatment compliance and&#xD;
        treatment outcomes of patients. Currently, there are some related studies on financial&#xD;
        toxicity in breast cancer patients, but they are mainly cross-sectional studies, lacking the&#xD;
        use of validated financial toxicity tools to measure the longitudinal change trajectory of&#xD;
        financial toxicity. The financial toxicity of breast cancer patients may change dynamically&#xD;
        with the treatment stage, expenditure and time, so it is necessary to conduct a rigorously&#xD;
        designed prospective study to explore the trajectory of financial toxicity. In addition,&#xD;
        previous studies have showed that financial toxicity may be associated with anxiety,&#xD;
        distress, pain and overall symptom burden. However, the relevant evidence is currently&#xD;
        limited. This study is designed as a prospective longitudinal study to explore the trajectory&#xD;
        of financial toxicity and its influencing factors in breast cancer patients in China, and to&#xD;
        focus on the relationship between symptom burden and financial toxicity, which will help&#xD;
        clinicians identify potential high-risk populations, and provide a new perspective for future&#xD;
        intervention programs.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">November 16, 2022</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2024</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</measure>
      <time_frame>Baseline, 3 months, 6 months, and 12 months</time_frame>
      <description>Measured with the Comprehensive Scores for Financial Toxicity Based on The Patient-reported Outcome Measures (COST-PROM). The total score is 0-44, and the lower the score, the more severe financial toxicity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physical symptom burden</measure>
      <time_frame>Baseline, 3 months, 6 months, and 12 months</time_frame>
      <description>Measured with the Breast Cancer Prevention Trial Eight Symptom Scale (BESS), which is a 5-point severity scale. The higher the score, the more severe the physical symptom burden.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Psychological symptom burden</measure>
      <time_frame>Baseline, 3 months, 6 months, and 12 months</time_frame>
      <description>Measured with Psychologic Symptom Distress Score (PHYS) of Memorial Symptom Assessment Scale Short Form (MSAS-SF), which adopted Likert 4 scale. The higher the score, the more severe the psychological symptom burden.</description>
    </primary_outcome>
    <enrollment type="Actual">485</enrollment>
    <condition>Financial Toxicity</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Breast cancer patients undergoing surgery at the Fudan University Shanghai Cancer Center,&#xD;
          the First Hospital of China Medical University, Wuhan Union Hospital and Xijing Hospital of&#xD;
          the Fourth Military Medical University.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed with breast cancer and underwent surgery&#xD;
  &#xD;
            -  Be going to receive one or more of chemotherapy, radiotherapy, targeted therapy,&#xD;
               endocrine therapy, and immunotherapy&#xD;
  &#xD;
            -  With the ability to understand and communicate in Chinese&#xD;
  &#xD;
            -  Provided informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Illness was considered too severe for participation&#xD;
  &#xD;
            -  With cognitive or psychiatric disorders&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Participant eligibility is based on self-representation of gender identity.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Fudan University Shanghai Cancer Center</name>
        <address>
          <city>Shanghai</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The First Hospital of China Medical University</name>
        <address>
          <city>Shenyang</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Wuhan Union Hospital</name>
        <address>
          <city>Wuhan</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Xijing Hospital of the Fourth Military Medical University</name>
        <address>
          <city>Xi'an</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fudan University</investigator_affiliation>
      <investigator_full_name>Yi Kuang</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Financial Stress</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is not a plan to make IPD available.</ipd_description>
    </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/NCT05964816
  org study id: YKuang
  nct id: NCT05964816
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Breast cancer has become the leading cause of global cancer incidence. With the improvement
        of treatment methods, some breast cancer patients have experienced different degrees of
        financial toxicity, which seriously affected the quality of life, treatment compliance and
        treatment outcomes of patients. Currently, there are some related studies on financial
        toxicity in breast cancer patients, but they are mainly cross-sectional studies, lacking the
        use of validated financial toxicity tools to measure the longitudinal change trajectory of
        financial toxicity. The financial toxicity of breast cancer patients may change dynamically
        with the treatment stage, expenditure and time, so it is necessary to conduct a rigorously
        designed prospective study to explore the trajectory of financial toxicity. In addition,
        previous studies have showed that financial toxicity may be associated with anxiety,
        distress, pain and overall symptom burden. However, the relevant evidence is currently
        limited. This study is designed as a prospective longitudinal study to explore the trajectory
        of financial toxicity and its influencing factors in breast cancer patients in China, and to
        focus on the relationship between symptom burden and financial toxicity, which will help
        clinicians identify potential high-risk populations, and provide a new perspective for future
        intervention programs.
  observational model: Cohort
  time perspective: Prospective
  measure: Financial toxicity
  time frame: Baseline, 3 months, 6 months, and 12 months
  description: Measured with the Comprehensive Scores for Financial Toxicity Based on The Patient-reported Outcome Measures (COST-PROM). The total score is 0-44, and the lower the score, the more severe financial toxicity.
  measure: Physical symptom burden
  time frame: Baseline, 3 months, 6 months, and 12 months
  description: Measured with the Breast Cancer Prevention Trial Eight Symptom Scale (BESS), which is a 5-point severity scale. The higher the score, the more severe the physical symptom burden.
  measure: Psychological symptom burden
  time frame: Baseline, 3 months, 6 months, and 12 months
  description: Measured with Psychologic Symptom Distress Score (PHYS) of Memorial Symptom Assessment Scale Short Form (MSAS-SF), which adopted Likert 4 scale. The higher the score, the more severe the psychological symptom burden.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Participant eligibility is based on self-representation of gender identity.
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  facility: 
  facility: 
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Fudan University
  investigator full name: Yi Kuang
  investigator title: Principal Investigator
  mesh term: Financial Stress
  sharing ipd: No
  ipd description: There is not a plan to make IPD available.