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/NCT05977504</url>
    </required_header>
    <id_info>
      <org_study_id>202302085RINC</org_study_id>
      <nct_id>NCT05977504</nct_id>
    </id_info>
    <brief_title>The Effectiveness of &quot;Multi-Psychological Empowerment&quot; Courses</brief_title>
    <official_title>The Effectiveness of &quot;Multi-Psychological Empowerment&quot; Courses Through Remote, Digital Media, Workshop Intervention for Oncology Nurses on Physical and Psychological Status, Self-Efficacy and Communication Ability</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan University 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>
    </oversight_info>
    <brief_summary>
      <textblock>
        In the first-year project of this study, oncology nurses have reported experiencing massive&#xD;
        stress, insufficient communication ability, and the need for communication-related training.&#xD;
        70% of them had moderate or higher severity of workload, fatigue, and psychological distress&#xD;
        (at the measure point) before being provided with Basic Remote Psychological Support Course&#xD;
        (BRPSC). A month after BRPSC, some oncology nurses have indicated/affirmed the benefits of&#xD;
        undergoing the comprehensive psycho oncology education training courses. Thus, the second-&#xD;
        and third-year continuation projects are focused on the development and delivery of&#xD;
        Multi-Psychological Empowerment Courses (MPEC) for oncology nurses&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The change in Physical and Psychological Symptoms</measure>
      <time_frame>5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks；Time 4:12th weeks；Time 5(back to work 1 month)</time_frame>
      <description>The change in oncology nurses' physical and psychological state will be measured by physical and psychological state survey. It use Numerical Rating Scale(VRS) 0-10. It is a 11 Point Likert Scale (e. g. 0 is no pain; 10 is unbearable pain).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change in Workload</measure>
      <time_frame>5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks；Time 4:12th weeks；Time 5(back to work 1 month)</time_frame>
      <description>The change in oncology nurses' workload will be measured by the self-designed scale using VRS (Numerical Rating Scale). It measures the subjective perception of oncology nurses about their workload in the past week, with scores ranging from 0 to 10.The higher the score, the greater the workload of the oncology nurses.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Self efficacy scale (GSES)</measure>
      <time_frame>5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks；Time 4:12th weeks；Time 5(back to work 1 month)</time_frame>
      <description>Oncology nurses' self-efficacy were measured by self efficacy scale. There are 10 questions about the level of confidence in these situations. It's a 4 point (1-4),higher the score means the more confident you have. There is also 11 point (0-10) scale that higher the score means the more confident you are in caring for patients.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Communication ability scale</measure>
      <time_frame>5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks；Time 4:12th weeks；Time 5(back to work 1 month)</time_frame>
      <description>Oncology nurses' communication skills were measured by communication ability scale.It is a 5 Liker scale(1-5),higher scores represent better communication skills.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Efferson Empathy Scale</measure>
      <time_frame>5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks；Time 4:12th weeks；Time 5(back to work 1 month)</time_frame>
      <description>Oncology nurses' empathy were measured by Efferson Empathy Scale. It is a 7 Liker scale(1-7),higher scores means someone have more empathy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being （FACIT-Sp）</measure>
      <time_frame>5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks；Time 4:12th weeks；Time 5(back to work 1 month)</time_frame>
      <description>Oncology nurses' spiritual well-being were measured by FACIT-Sp.It is a 5 Liker scale(0-4),higher scores represent better well-being.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Burnout Inventory survey</measure>
      <time_frame>5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks；Time 4:12th weeks；Time 5(back to work 1 month)</time_frame>
      <description>Oncology nurses' burnout will be measured by Burnout Inventory survey.It is a 7 Liker scale(0-6),higher scores represent high level burnout .</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Cancer</condition>
    <condition>Oncology</condition>
    <condition>Psychological</condition>
    <condition>Self Efficacy</condition>
    <condition>Communication</condition>
    <arm_group>
      <arm_group_label>Multi-Psychological Empowerment Courses</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>9 times online course and 3-days workshop for 6 months .</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants in control group will receive usual course.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Multi-Psychological Empowerment Courses</intervention_name>
      <description>9 times online course and 3-days workshop for 6 months of psychological Empowerment Courses.</description>
      <arm_group_label>Multi-Psychological Empowerment Courses</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Intervention group&#xD;
  &#xD;
            -  Inclusion Criteria:&#xD;
  &#xD;
            -  Over 20 years old (inclusive)&#xD;
  &#xD;
            -  Oncology nurses currently working in clinical practice&#xD;
  &#xD;
            -  At least receiving one course related to oncology nurse training, such as chemotherapy&#xD;
               for nursing staff or oncology advanced training courses.&#xD;
  &#xD;
            -  Exclusion Criteria:&#xD;
  &#xD;
            -  Those who are unwilling or unable to participate in this course training for a full&#xD;
               one- year period.&#xD;
  &#xD;
          Control group Oncology nurses who do not need to be recruited for the comparison group will&#xD;
          be students who participated in the remote psychological support course of the first year&#xD;
          project effective comparison groups.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yun Hsiang Lee, PhD</last_name>
      <phone>886 2 23123456</phone>
      <phone_ext>88424</phone_ext>
      <email>yhlee338@ntu.edu.tw</email>
    </overall_contact>
    <location>
      <facility>
        <name>National Taiwan University Hospital</name>
        <address>
          <city>Taipei</city>
          <zip>802</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <contact>
        <last_name>Yun Hsiang Lee, PhD</last_name>
        <phone>886 2 23123456</phone>
        <phone_ext>88424</phone_ext>
        <email>yhlee338@ntu.edu.tw</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 3, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Training course</keyword>
    <keyword>Oncology nurse</keyword>
    <keyword>Psychological support</keyword>
    <keyword>Self-efficacy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <!-- 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/NCT05977504
  org study id: 202302085RINC
  nct id: NCT05977504
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In the first-year project of this study, oncology nurses have reported experiencing massive
        stress, insufficient communication ability, and the need for communication-related training.
        70% of them had moderate or higher severity of workload, fatigue, and psychological distress
        (at the measure point) before being provided with Basic Remote Psychological Support Course
        (BRPSC). A month after BRPSC, some oncology nurses have indicated/affirmed the benefits of
        undergoing the comprehensive psycho oncology education training courses. Thus, the second-
        and third-year continuation projects are focused on the development and delivery of
        Multi-Psychological Empowerment Courses (MPEC) for oncology nurses
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: The change in Physical and Psychological Symptoms
  time frame: 5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks；Time 4:12th weeks；Time 5(back to work 1 month)
  description: The change in oncology nurses' physical and psychological state will be measured by physical and psychological state survey. It use Numerical Rating Scale(VRS) 0-10. It is a 11 Point Likert Scale (e. g. 0 is no pain; 10 is unbearable pain).
  measure: The change in Workload
  time frame: 5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks；Time 4:12th weeks；Time 5(back to work 1 month)
  description: The change in oncology nurses' workload will be measured by the self-designed scale using VRS (Numerical Rating Scale). It measures the subjective perception of oncology nurses about their workload in the past week, with scores ranging from 0 to 10.The higher the score, the greater the workload of the oncology nurses.
  measure: Self efficacy scale (GSES)
  time frame: 5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks；Time 4:12th weeks；Time 5(back to work 1 month)
  description: Oncology nurses' self-efficacy were measured by self efficacy scale. There are 10 questions about the level of confidence in these situations. It's a 4 point (1-4),higher the score means the more confident you have. There is also 11 point (0-10) scale that higher the score means the more confident you are in caring for patients.
  measure: Communication ability scale
  time frame: 5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks；Time 4:12th weeks；Time 5(back to work 1 month)
  description: Oncology nurses' communication skills were measured by communication ability scale.It is a 5 Liker scale(1-5),higher scores represent better communication skills.
  measure: Efferson Empathy Scale
  time frame: 5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks；Time 4:12th weeks；Time 5(back to work 1 month)
  description: Oncology nurses' empathy were measured by Efferson Empathy Scale. It is a 7 Liker scale(1-7),higher scores means someone have more empathy.
  measure: Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being （FACIT-Sp）
  time frame: 5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks；Time 4:12th weeks；Time 5(back to work 1 month)
  description: Oncology nurses' spiritual well-being were measured by FACIT-Sp.It is a 5 Liker scale(0-4),higher scores represent better well-being.
  measure: Burnout Inventory survey
  time frame: 5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks；Time 4:12th weeks；Time 5(back to work 1 month)
  description: Oncology nurses' burnout will be measured by Burnout Inventory survey.It is a 7 Liker scale(0-6),higher scores represent high level burnout .
  arm group label: Multi-Psychological Empowerment Courses
  arm group type: Experimental
  description: 9 times online course and 3-days workshop for 6 months .
  arm group label: Control group
  arm group type: No Intervention
  description: Participants in control group will receive usual course.
  intervention type: Other
  intervention name: Multi-Psychological Empowerment Courses
  description: 9 times online course and 3-days workshop for 6 months of psychological Empowerment Courses.
  arm group label: Multi-Psychological Empowerment Courses
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yun Hsiang Lee, PhD
  phone: 886 2 23123456
  phone ext: 88424
  email: yhlee338@ntu.edu.tw
  facility: 
  contact: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Neoplasms