<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/NCT03780023</url>
  </required_header>
  <id_info>
    <org_study_id>1072827</org_study_id>
    <nct_id>NCT03780023</nct_id>
  </id_info>
  <brief_title>CCRO044: Quality of Life Assessments Associated With a Physician Communication Intervention for Prostate Cancer Patients</brief_title>
  <official_title>Pilot Study to Measure the Health-related Quality of Life Associated With a Physician Communication Intervention for Prostate Cancer Patients Undergoing Definitive or Post-operative Radiation Treatment.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</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>
      A generic cancer health-related quality of life measure will be used to assess the impact of&#xD;
      the patient-specific radiation therapy plan review using the European Organisation for&#xD;
      Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30. Patient&#xD;
      psychosocial adjustment will be assessed by the Memorial Anxiety Scale for prostate cancer&#xD;
      and the EORTC QLQ-C30 subdomain. Physician communication will be assessed with the UC Davis&#xD;
      Physician Communication adapted from the Cologne Patient Questionnaire.&#xD;
&#xD;
      The study will characterize the above health-related quality of life (HRQL) scores (EORTC QLQ&#xD;
      C-30, the Memorial Anxiety Scale, and the UC Davis Physician Communication) prior to&#xD;
      initiation of radiation (baseline), during the first week of treatment, at the end of&#xD;
      radiation treatment (6-8 weeks following initiation of treatment), and 12 months after&#xD;
      treatment ends.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary purpose of this pilot study is to assess the feasibility of administrating a&#xD;
      battery of HRQL measures after the planned intervention is administered. Because&#xD;
      distributional information on the proposed HRQL measure has not been previously collected in&#xD;
      prostate cancer patients, this pilot study will provide the necessary descriptive statistical&#xD;
      information for the planned endpoint measures (summary scores for the HRQL battery) to help&#xD;
      plan a randomized trial evaluating the efficacy of the patient-provider communication&#xD;
      intervention. Men who are receiving definitive or post-operative radiation therapy for&#xD;
      management of prostate cancer at the University of California (UC) Davis will be recruited.&#xD;
&#xD;
      The study will administer a validated quality of life instrument (EORTC QLQ-C30), a&#xD;
      previously validated psychosocial instrument (Memorial Anxiety Scale), and assessment of&#xD;
      physician-patient communication using a new UC Davis Physician Communication Assessment&#xD;
      adapted from the validated Cologne Patient Questionnaire. The study will administer these&#xD;
      questionnaires prior to initiation of radiation (baseline), during the first week of&#xD;
      treatment, at the end of radiation treatment (6-8 weeks following initiation of treatment),&#xD;
      and 12 months after treatment ends.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 17, 2017</start_date>
  <completion_date type="Actual">May 4, 2020</completion_date>
  <primary_completion_date type="Actual">May 4, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in health-related quality of life</measure>
    <time_frame>Baseline, 6 to 8 weeks</time_frame>
    <description>The mean change in scores on the EORTC QLQ-C30 scale from pre-treatment to post-treatment. This scale has functional, global health, and symptoms subscales/items all scored from 0 to 100. Higher scores on these subscales indicate high level of functioning, high quality of life, and high level of symptomatology, respectively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in psychosocial health</measure>
    <time_frame>Baseline, 6 to 8 weeks</time_frame>
    <description>The mean change in scores on the Modified 18-item Memorial Anxiety Scale for Prostate Cancer from pre-treatment to post-treatment. The scale consists of 18 items (e.g. &quot;I thought about prostate cancer even though I didn't mean to.&quot;) scored on a scale from 0 (&quot;not at all&quot;) to 3 (&quot;often&quot;). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in physician-patient communication</measure>
    <time_frame>Baseline, 6 to 8 weeks</time_frame>
    <description>The mean change in scores on the UC Davis Physician Communication Assessment from pre-treatment to post-treatment. This scale was adapted from the validated Cologne Patient Questionnaire, which has subscales measuring devotion, support, information, and shared decision-making. Participants indicate their level of agreement with each item, from &quot;totally disagree&quot; to &quot;totally agree.&quot;</description>
  </primary_outcome>
  <enrollment type="Actual">5</enrollment>
  <condition>Prostate Adenocarcinoma</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>All patients will receive three questionnaires at four different time points during their radiation treatment. The time points are 1) before treatment, 2) during the first week of treatment, 3) at the end of treatment (6-8 weeks after treatment begins), and 4) one year after treatment ends.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Men age 18 and over with a diagnosis of prostate adenocarcinoma that is not characterized&#xD;
        by metastatic cancer or positive pelvic nodes.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of prostate adenocarcinoma over the age of 18 years&#xD;
&#xD;
          2. Low, intermediate or high risk as defined by D'Amico risk groups treated with dose&#xD;
             escalated conventional fractionated radiation therapy&#xD;
&#xD;
          3. Patient deemed clinically appropriate for definitive, adjuvant or salvage radiation.&#xD;
&#xD;
          4. Patient most provide study specific informed consent prior to study entry.&#xD;
&#xD;
          5. Androgen deprivation allowed&#xD;
&#xD;
          6. Pelvic lymph radiation therapy allowed for high risk disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Metastatic prostate cancer&#xD;
&#xD;
          2. Positive pelvic nodes&#xD;
&#xD;
          3. Patients treated with radiation for palliative intent&#xD;
&#xD;
          4. Prior radiation therapy to the pelvis&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>This is a prostate cancer protocol.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard K Valicenti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California Davis Health</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>October 26, 2020</last_update_submitted>
  <last_update_submitted_qc>October 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03780023
org study id: 1072827
nct id: NCT03780023
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A generic cancer health-related quality of life measure will be used to assess the impact of
      the patient-specific radiation therapy plan review using the European Organisation for
      Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30. Patient
      psychosocial adjustment will be assessed by the Memorial Anxiety Scale for prostate cancer
      and the EORTC QLQ-C30 subdomain. Physician communication will be assessed with the UC Davis
      Physician Communication adapted from the Cologne Patient Questionnaire.

      The study will characterize the above health-related quality of life (HRQL) scores (EORTC QLQ
      C-30, the Memorial Anxiety Scale, and the UC Davis Physician Communication) prior to
      initiation of radiation (baseline), during the first week of treatment, at the end of
      radiation treatment (6-8 weeks following initiation of treatment), and 12 months after
      treatment ends.
The primary purpose of this pilot study is to assess the feasibility of administrating a
      battery of HRQL measures after the planned intervention is administered. Because
      distributional information on the proposed HRQL measure has not been previously collected in
      prostate cancer patients, this pilot study will provide the necessary descriptive statistical
      information for the planned endpoint measures (summary scores for the HRQL battery) to help
      plan a randomized trial evaluating the efficacy of the patient-provider communication
      intervention. Men who are receiving definitive or post-operative radiation therapy for
      management of prostate cancer at the University of California (UC) Davis will be recruited.

      The study will administer a validated quality of life instrument (EORTC QLQ-C30), a
      previously validated psychosocial instrument (Memorial Anxiety Scale), and assessment of
      physician-patient communication using a new UC Davis Physician Communication Assessment
      adapted from the validated Cologne Patient Questionnaire. The study will administer these
      questionnaires prior to initiation of radiation (baseline), during the first week of
      treatment, at the end of radiation treatment (6-8 weeks following initiation of treatment),
      and 12 months after treatment ends.
observational model: Case-Only
time perspective: Prospective
measure: Change in health-related quality of life
time frame: Baseline, 6 to 8 weeks
description: The mean change in scores on the EORTC QLQ-C30 scale from pre-treatment to post-treatment. This scale has functional, global health, and symptoms subscales/items all scored from 0 to 100. Higher scores on these subscales indicate high level of functioning, high quality of life, and high level of symptomatology, respectively.
measure: Change in psychosocial health
time frame: Baseline, 6 to 8 weeks
description: The mean change in scores on the Modified 18-item Memorial Anxiety Scale for Prostate Cancer from pre-treatment to post-treatment. The scale consists of 18 items (e.g. "I thought about prostate cancer even though I didn't mean to.") scored on a scale from 0 ("not at all") to 3 ("often"). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety.
measure: Change in physician-patient communication
time frame: Baseline, 6 to 8 weeks
description: The mean change in scores on the UC Davis Physician Communication Assessment from pre-treatment to post-treatment. This scale was adapted from the validated Cologne Patient Questionnaire, which has subscales measuring devotion, support, information, and shared decision-making. Participants indicate their level of agreement with each item, from "totally disagree" to "totally agree."
intervention type: Other
intervention name: Questionnaire
description: All patients will receive three questionnaires at four different time points during their radiation treatment. The time points are 1) before treatment, 2) during the first week of treatment, 3) at the end of treatment (6-8 weeks after treatment begins), and 4) one year after treatment ends.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
gender based: Yes
gender description: This is a prostate cancer protocol.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard K Valicenti, MD
role: Principal Investigator
affiliation: University of California, Davis
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided