<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/NCT04507568</url>
  </required_header>
  <id_info>
    <org_study_id>20-5111</org_study_id>
    <nct_id>NCT04507568</nct_id>
  </id_info>
  <brief_title>The Person-centered Evolution of Radiotherapy Services in Ontario Study</brief_title>
  <official_title>The Person-centered Evolution of Radiotherapy Services in Ontario (PERSON) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</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>
      This is a single center, prospective, investigator initiated, randomized controlled study of&#xD;
      patients with breast cancer who will be receiving radiation therapy as per SOC. Patients will&#xD;
      be randomized in either the person-centered model-of-care versus the standard model of care.&#xD;
&#xD;
      Patients randomized to the person-centered model-of-care will have a 30 minute education&#xD;
      session with a radiation therapist in addition to RT SOC procedures. Patients randomized to&#xD;
      the standard model of care will be treated as per SOC. Questionnaires will be administered to&#xD;
      both arms at baseline, and at the first and last day of treatment. In addition to the main&#xD;
      study, patients will have the option to participate in a semi-structured one on one interview&#xD;
      upon completion of their radiotherapy course.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Radiation therapy plays an integral role in the definitive treatment of breast cancer by&#xD;
      reducing the risk of locoregional recurrence and improving patient outcomes. Despite the&#xD;
      availability of supportive care services, many patients have unmet needs which may lead to&#xD;
      unexpected negative outcomes. Anxiety can affect patients' ability to cope, interfere with&#xD;
      treatment and self-manage their own care. Strategies to improve cancer care include patient&#xD;
      navigators or case managers, early interventions and self-management of side effects to&#xD;
      reduce treatment-related toxicities. Therefore, minimizing distress from treatment and&#xD;
      engaging patients by personalizing care according to their unique needs will optimize use of&#xD;
      supportive care services and improve clinical outcomes.&#xD;
&#xD;
      A Cochrane review demonstrated that information and supportive care sessions delivered by&#xD;
      non-physician healthcare providers improves both emotional wellbeing and quality of life in&#xD;
      breast cancer patients. A prospective randomized, Australian study by Halkett et al.&#xD;
      demonstrated that an education intervention delivered one-on-one by Radiation Therapists&#xD;
      effectively reduces breast cancer patients' psychological distress and improves preparedness&#xD;
      for treatment. This highlights the importance of early and accessible education resources&#xD;
      where patients experience direct access to the radiation therapy team.&#xD;
&#xD;
      Further research is required to investigate the efficacy of person-centered model on patient&#xD;
      experiences and relevant clinical outcomes. Specifically, it is expected this model will&#xD;
      reduce patient anxiety, improve preparedness for radiation therapy through education, and&#xD;
      improve patient self-management of radiation-toxicities. The proposed study focuses on&#xD;
      patients with breast cancer because of the experience in testing the model on this group and&#xD;
      their relatively uniform treatment at all Ontario cancer centres, which will facilitate&#xD;
      translation of this model in the future. A randomized controlled study will determine the&#xD;
      efficacy of the person-centered model versus standard care, and generate high-quality&#xD;
      evidence in an unbiased setting that was not possible in the prior clinical pilot phases.&#xD;
&#xD;
      Personalizing patient experiences in radiotherapy, coupled with improvements in treatment&#xD;
      quality and supportive care, may improve clinical outcomes including toxicity and quality of&#xD;
      life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 13, 2020</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Anxiety Levels</measure>
    <time_frame>Up to 5 weeks.</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS) questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient-reported self-efficacy</measure>
    <time_frame>Up to 5 weeks.</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) Self Efficacy Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported engagement level</measure>
    <time_frame>Up to 5 weeks.</time_frame>
    <description>Patient Health Engagement (PHE) survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported experience</measure>
    <time_frame>Up to 5 weeks.</time_frame>
    <description>EORTC satisfaction with cancer care core (EORTC PATSAT-C33) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported experience</measure>
    <time_frame>Up to 5 weeks.</time_frame>
    <description>Specific complementary outpatient module (EORTC OUT-PATSAT7) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported preparedness for radiation therapy</measure>
    <time_frame>Up to 5 weeks.</time_frame>
    <description>Cancer Treatment Survey (CaTS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Person-Centered Model-of-Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to the person-centered model-of-care will have a 30 minute education session with a radiation therapist in addition to the standard of care, radiation therapy procedures.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Model-of-Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients randomized to the standard model of care will be treated as per standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality of Life Questionnaires</intervention_name>
    <description>Quality of Life questionnaires will be administered to both arms at baseline, and at the first and last day of treatment.</description>
    <arm_group_label>Person-Centered Model-of-Care</arm_group_label>
    <arm_group_label>Standard Model-of-Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18 years or older&#xD;
&#xD;
          -  Diagnosis of non-metastatic breast cancer&#xD;
&#xD;
          -  Intended to receive radiation therapy to the breast/chest-wall and regional lymph&#xD;
             nodes&#xD;
&#xD;
          -  Ability to communicate in English without assistance of another person&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Commenced any radiation therapy-specific procedures (e.g. education, CT-simulation,&#xD;
             etc.)&#xD;
&#xD;
          -  Received a previous course of radiation therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>August 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>April 5, 2023</last_update_submitted>
  <last_update_submitted_qc>April 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Radiation Therapy</keyword>
  <keyword>Patient Experience</keyword>
  <keyword>Anxiety Levels</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/NCT04507568
org study id: 20-5111
nct id: NCT04507568
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a single center, prospective, investigator initiated, randomized controlled study of
      patients with breast cancer who will be receiving radiation therapy as per SOC. Patients will
      be randomized in either the person-centered model-of-care versus the standard model of care.

      Patients randomized to the person-centered model-of-care will have a 30 minute education
      session with a radiation therapist in addition to RT SOC procedures. Patients randomized to
      the standard model of care will be treated as per SOC. Questionnaires will be administered to
      both arms at baseline, and at the first and last day of treatment. In addition to the main
      study, patients will have the option to participate in a semi-structured one on one interview
      upon completion of their radiotherapy course.
Radiation therapy plays an integral role in the definitive treatment of breast cancer by
      reducing the risk of locoregional recurrence and improving patient outcomes. Despite the
      availability of supportive care services, many patients have unmet needs which may lead to
      unexpected negative outcomes. Anxiety can affect patients' ability to cope, interfere with
      treatment and self-manage their own care. Strategies to improve cancer care include patient
      navigators or case managers, early interventions and self-management of side effects to
      reduce treatment-related toxicities. Therefore, minimizing distress from treatment and
      engaging patients by personalizing care according to their unique needs will optimize use of
      supportive care services and improve clinical outcomes.

      A Cochrane review demonstrated that information and supportive care sessions delivered by
      non-physician healthcare providers improves both emotional wellbeing and quality of life in
      breast cancer patients. A prospective randomized, Australian study by Halkett et al.
      demonstrated that an education intervention delivered one-on-one by Radiation Therapists
      effectively reduces breast cancer patients' psychological distress and improves preparedness
      for treatment. This highlights the importance of early and accessible education resources
      where patients experience direct access to the radiation therapy team.

      Further research is required to investigate the efficacy of person-centered model on patient
      experiences and relevant clinical outcomes. Specifically, it is expected this model will
      reduce patient anxiety, improve preparedness for radiation therapy through education, and
      improve patient self-management of radiation-toxicities. The proposed study focuses on
      patients with breast cancer because of the experience in testing the model on this group and
      their relatively uniform treatment at all Ontario cancer centres, which will facilitate
      translation of this model in the future. A randomized controlled study will determine the
      efficacy of the person-centered model versus standard care, and generate high-quality
      evidence in an unbiased setting that was not possible in the prior clinical pilot phases.

      Personalizing patient experiences in radiotherapy, coupled with improvements in treatment
      quality and supportive care, may improve clinical outcomes including toxicity and quality of
      life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Patient Anxiety Levels
time frame: Up to 5 weeks.
description: Hospital Anxiety and Depression Scale (HADS) questionnaire
measure: Patient-reported self-efficacy
time frame: Up to 5 weeks.
description: Patient-Reported Outcomes Measurement Information System (PROMIS) Self Efficacy Survey
measure: Patient-reported engagement level
time frame: Up to 5 weeks.
description: Patient Health Engagement (PHE) survey
measure: Patient-reported experience
time frame: Up to 5 weeks.
description: EORTC satisfaction with cancer care core (EORTC PATSAT-C33) questionnaire
measure: Patient-reported experience
time frame: Up to 5 weeks.
description: Specific complementary outpatient module (EORTC OUT-PATSAT7) questionnaire
measure: Patient-reported preparedness for radiation therapy
time frame: Up to 5 weeks.
description: Cancer Treatment Survey (CaTS)
arm group label: Person-Centered Model-of-Care
arm group type: Experimental
description: Patients randomized to the person-centered model-of-care will have a 30 minute education session with a radiation therapist in addition to the standard of care, radiation therapy procedures.
arm group label: Standard Model-of-Care
arm group type: Other
description: Patients randomized to the standard model of care will be treated as per standard of care.
intervention type: Other
intervention name: Quality of Life Questionnaires
description: Quality of Life questionnaires will be administered to both arms at baseline, and at the first and last day of treatment.
arm group label: Person-Centered Model-of-Care
arm group label: Standard Model-of-Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor