<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/NCT03770598</url>
  </required_header>
  <id_info>
    <org_study_id>18-000718</org_study_id>
    <nct_id>NCT03770598</nct_id>
  </id_info>
  <brief_title>Team Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients</brief_title>
  <official_title>Team Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      Researchers are trying to see if proactive identification and team based individualized care&#xD;
      of cancer patients having emotional difficulties can improve quality of life relative to&#xD;
      treatment as usual. Also, to see if proactive approaches to maintain wellness can prevent&#xD;
      grief among breast cancer patients, experiencing no emotional difficulties relative to&#xD;
      treatment as usual.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Consented subjects will be randomized into two separate groups. Groups will be distressed and&#xD;
      non-distressed subjects. Each group will be randomized into either intervention education&#xD;
      training or standard of care. Both groups will be asked to fill out questionnaires during the&#xD;
      duration of the study. Subjects will be remain in the study for up to one year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 28, 2018</start_date>
  <completion_date type="Anticipated">November 2024</completion_date>
  <primary_completion_date type="Anticipated">November 2024</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>
    <intervention_model_description>Non-Distressed patients will be randomized to receive intervention or standard of care.&#xD;
Distressed patients will be randomized to receive intervention or standard of care</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Wellness</measure>
    <time_frame>baseline, 6 months</time_frame>
    <description>Subject wellness scores based on Short Warwick-Edinburgh Mental-Wellbeing Scale. This is a 7 item scale monitoring of mental wellbeing in subjects. Responses are based on a 1 to 5 item scale with 1 = None of the time, 2 = Rarely, 3 = Some of the Time, 4 = Often, 5 = All of the Time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in depression compared to baseline</measure>
    <time_frame>one year</time_frame>
    <description>measured by using PHQ-8 (Patient Health Questionnaire); this is an 8 item scale. Scores of 5 or less are considered no depression, 5-10, mild depression, 11-15, moderate depression, 16-20 moderately severe and more than 20 is considered severe depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in anxiety compared to baseline</measure>
    <time_frame>One Year</time_frame>
    <description>Will be measured by GAD-7 (Generalized Anxiety Disorder 7-item Scale). Its a 7 item scale. Cut points of 5, 10, 15 represent mild, moderate and severe levels of anxiety.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Distressed</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study participants who do indicate distress or who do meet criteria for depression or anxiety will be randomized to receive either treatment as usual (referral to Psychiatry or Psychology for evaluation and further treatment) or team based care model.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Distressed</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study participants who do not indicate distress or who do not meet criteria for depression or anxiety will be randomize to monitoring only or to receive psycho-education regarding subjects that when used can promote wellness.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard of Care Distressed in study Arm Distressed</intervention_name>
    <description>Social worker evaluation and possible referral to Psychiatry/Psychology for evaluation and further treatment.</description>
    <arm_group_label>Distressed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psycho-Education</intervention_name>
    <description>Mindfulness based stress reduction class, yoga and education material</description>
    <arm_group_label>Non-Distressed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Team Based Care</intervention_name>
    <description>Psychiatrist, Oncologist, clinical social worker, study coordinator</description>
    <arm_group_label>Distressed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard of Care Non-Distressed</intervention_name>
    <description>No psycho-education about wellness promotion or health. These patients will be monitored only.</description>
    <arm_group_label>Non-Distressed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of breast cancer within last three years&#xD;
&#xD;
          -  Able to communicate in English or with the help of an interpreter.&#xD;
&#xD;
          -  Access to a device with internet connection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Breast cancer patients who are considered for hospice or expected survival of less&#xD;
             than six months.&#xD;
&#xD;
          -  Presence of active suicidal ideations.&#xD;
&#xD;
          -  Presence of active psychosis.&#xD;
&#xD;
          -  Presence of dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shehzad K Niazi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>February 21, 2023</last_update_submitted>
  <last_update_submitted_qc>February 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Shehzad K. Niazi</investigator_full_name>
    <investigator_title>Prinicpal Investigator</investigator_title>
  </responsible_party>
  <keyword>Psychosocial Care</keyword>
  <keyword>Wellness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03770598
org study id: 18-000718
nct id: NCT03770598
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Researchers are trying to see if proactive identification and team based individualized care
      of cancer patients having emotional difficulties can improve quality of life relative to
      treatment as usual. Also, to see if proactive approaches to maintain wellness can prevent
      grief among breast cancer patients, experiencing no emotional difficulties relative to
      treatment as usual.
Consented subjects will be randomized into two separate groups. Groups will be distressed and
      non-distressed subjects. Each group will be randomized into either intervention education
      training or standard of care. Both groups will be asked to fill out questionnaires during the
      duration of the study. Subjects will be remain in the study for up to one year.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Non-Distressed patients will be randomized to receive intervention or standard of care.
Distressed patients will be randomized to receive intervention or standard of care
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Wellness
time frame: baseline, 6 months
description: Subject wellness scores based on Short Warwick-Edinburgh Mental-Wellbeing Scale. This is a 7 item scale monitoring of mental wellbeing in subjects. Responses are based on a 1 to 5 item scale with 1 = None of the time, 2 = Rarely, 3 = Some of the Time, 4 = Often, 5 = All of the Time.
measure: Improvement in depression compared to baseline
time frame: one year
description: measured by using PHQ-8 (Patient Health Questionnaire); this is an 8 item scale. Scores of 5 or less are considered no depression, 5-10, mild depression, 11-15, moderate depression, 16-20 moderately severe and more than 20 is considered severe depression.
measure: Improvement in anxiety compared to baseline
time frame: One Year
description: Will be measured by GAD-7 (Generalized Anxiety Disorder 7-item Scale). Its a 7 item scale. Cut points of 5, 10, 15 represent mild, moderate and severe levels of anxiety.
arm group label: Distressed
arm group type: Active Comparator
description: Study participants who do indicate distress or who do meet criteria for depression or anxiety will be randomized to receive either treatment as usual (referral to Psychiatry or Psychology for evaluation and further treatment) or team based care model.
arm group label: Non-Distressed
arm group type: Active Comparator
description: Study participants who do not indicate distress or who do not meet criteria for depression or anxiety will be randomize to monitoring only or to receive psycho-education regarding subjects that when used can promote wellness.
intervention type: Behavioral
intervention name: Standard of Care Distressed in study Arm Distressed
description: Social worker evaluation and possible referral to Psychiatry/Psychology for evaluation and further treatment.
arm group label: Distressed
intervention type: Behavioral
intervention name: Psycho-Education
description: Mindfulness based stress reduction class, yoga and education material
arm group label: Non-Distressed
intervention type: Behavioral
intervention name: Team Based Care
description: Psychiatrist, Oncologist, clinical social worker, study coordinator
arm group label: Distressed
intervention type: Behavioral
intervention name: Standard of Care Non-Distressed
description: No psycho-education about wellness promotion or health. These patients will be monitored only.
arm group label: Non-Distressed
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shehzad K Niazi
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Shehzad K. Niazi
investigator title: Prinicpal Investigator
mesh term: Breast Neoplasms