<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/NCT04411251</url>
  </required_header>
  <id_info>
    <org_study_id>TK-Onko</org_study_id>
    <nct_id>NCT04411251</nct_id>
  </id_info>
  <brief_title>Evaluation of a Oncology Day Care Unit Programme With Two Different Focuses</brief_title>
  <acronym>TK-Onko</acronym>
  <official_title>Integrative Oncology - Evaluation of a Oncology Day Care Unit Programme With Two Different Focuses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</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>
      The aim of this study is to investigate the effects of a nature-centred integrative oncology&#xD;
      day care unit programme (&quot;outdoor concept&quot;) compared with an already established integrative&#xD;
      oncology day care unit programme (&quot;indoor concept&quot;).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 14, 2020</start_date>
  <completion_date type="Actual">May 1, 2022</completion_date>
  <primary_completion_date type="Actual">May 1, 2022</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional Assessment of Cancer Therapy - General (FACT-G)</measure>
    <time_frame>Change from date of inclusion (baseline) at 12 weeks and at 24 weeks</time_frame>
    <description>Assessing full scale, range 0-108, higher score meaning a better outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)</measure>
    <time_frame>Date of inclusion (baseline), after 12 weeks, after 24 weeks</time_frame>
    <description>Assessing full scale, range 0-40, higher score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment of Cancer Therapy: Fatigue (FACT-F)</measure>
    <time_frame>Date of inclusion (baseline), after 12 weeks, after 24 weeks</time_frame>
    <description>Assessing full scale, range 0-52, higher score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WHO-Five Well-Being Index (WHO-5)</measure>
    <time_frame>Date of inclusion (baseline), after 12 weeks, after 24 weeks</time_frame>
    <description>Assessing full scale, range 0-25, higher score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Benefits of Nature Questionnaire (PBNQ)</measure>
    <time_frame>Date of inclusion (baseline), after 12 weeks, after 24 weeks</time_frame>
    <description>mean score of the 11 items, range 1-7, lower score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS-10)</measure>
    <time_frame>Date of inclusion (baseline), after 12 weeks, after 24 weeks</time_frame>
    <description>Assessing full scale, range 0-40, lower score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>Date of inclusion (baseline), after 12 weeks, after 24 weeks</time_frame>
    <description>Assessing full scale, range 0-42, lower score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flourishing Scale (FS-D)</measure>
    <time_frame>Date of inclusion (baseline), after 12 weeks, after 24 weeks</time_frame>
    <description>Assessing full scale, range 8-56, higher score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freiburg Mindfulness Inventory (FMI)</measure>
    <time_frame>Date of inclusion (baseline), after 12 weeks, after 24 weeks</time_frame>
    <description>Assessing full scale, range 0-56, higher score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia Severity Index (ISI)</measure>
    <time_frame>Date of inclusion (baseline), after 12 weeks, after 24 weeks</time_frame>
    <description>Assessing full scale, range 0-28, lower score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy Scale - Short Form (ASKU)</measure>
    <time_frame>Date of inclusion (baseline), after 12 weeks, after 24 weeks</time_frame>
    <description>mean score of the 3 items, range 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Compassion Scale (SCS-D)</measure>
    <time_frame>Date of inclusion (baseline), after 12 weeks, after 24 weeks</time_frame>
    <description>mean score of 12 items, range 1-5, higher score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral questions: alcohol consumption</measure>
    <time_frame>Date of inclusion (baseline), after 12 weeks, after 24 weeks</time_frame>
    <description>Number of alcoholic beverages on average per week in the last month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral questions: relaxation</measure>
    <time_frame>Date of inclusion (baseline), after 12 weeks, after 24 weeks</time_frame>
    <description>Relaxation behavior on average per week in the last month in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral questions: cigarettes</measure>
    <time_frame>Date of inclusion (baseline), after 12 weeks, after 24 weeks</time_frame>
    <description>Number of cigarettes on average per week in the last month in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sociodemographic Measurements</measure>
    <time_frame>Date of inclusion (baseline)</time_frame>
    <description>Age, gender, education level, household income, employment status, marital status, complete family history, current and previous diseases and co-morbidities, current medication intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>Date of inclusion (baseline), after 12 weeks, after 24 weeks</time_frame>
    <description>kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expectation questions</measure>
    <time_frame>Date of inclusion (baseline)</time_frame>
    <description>For intervention 1 and intervention 2 on a 5-point likert scale from 1 (nothing at all) to 5 (very strong)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral questions: sport</measure>
    <time_frame>Date of inclusion (baseline), after 12 weeks, after 24 weeks</time_frame>
    <description>Sports behavior on average per week in the last month in minutes</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Qualitative interviews</measure>
    <time_frame>12 weeks and 24 weeks after inclusion</time_frame>
    <description>Qualitative assessment will be carried out in qualitative interviews in 20 patients participating in the study. The interviews will be recorded, transcribed and analyzed with qualitative content analysis.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">107</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Outdoor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nature-centered therapy in a near-natural area</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Indoor</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional therapy in rooms mainly in a hospital building</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nature-near integrative day care unit programme</intervention_name>
    <description>Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme</description>
    <arm_group_label>Outdoor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Conventional integrative day care unit programme</intervention_name>
    <description>Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme</description>
    <arm_group_label>Indoor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - cancer diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cognitive impairment that would interfere with questionnaire replies or the&#xD;
             intervention&#xD;
&#xD;
          -  pregnancy or lactation&#xD;
&#xD;
          -  known serious mental illness&#xD;
&#xD;
          -  participation in another study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus</name>
      <address>
        <city>Berlin</city>
        <zip>14109</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 1, 2023</last_update_submitted>
  <last_update_submitted_qc>June 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Andreas Michalsen</investigator_full_name>
    <investigator_title>Prof. Dr. med.</investigator_title>
  </responsible_party>
  <keyword>Nature</keyword>
  <keyword>Mind-Body Therapies</keyword>
  <keyword>Mindfulness</keyword>
  <keyword>Yoga</keyword>
  <keyword>Meditation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT04411251
org study id: TK-Onko
nct id: NCT04411251
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate the effects of a nature-centred integrative oncology
      day care unit programme ("outdoor concept") compared with an already established integrative
      oncology day care unit programme ("indoor concept").
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Functional Assessment of Cancer Therapy - General (FACT-G)
time frame: Change from date of inclusion (baseline) at 12 weeks and at 24 weeks
description: Assessing full scale, range 0-108, higher score meaning a better outcome
measure: Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
description: Assessing full scale, range 0-40, higher score meaning a better outcome
measure: Functional Assessment of Cancer Therapy: Fatigue (FACT-F)
time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
description: Assessing full scale, range 0-52, higher score meaning a better outcome
measure: WHO-Five Well-Being Index (WHO-5)
time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
description: Assessing full scale, range 0-25, higher score meaning a better outcome
measure: Perceived Benefits of Nature Questionnaire (PBNQ)
time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
description: mean score of the 11 items, range 1-7, lower score meaning a better outcome
measure: Perceived Stress Scale (PSS-10)
time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
description: Assessing full scale, range 0-40, lower score meaning a better outcome
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
description: Assessing full scale, range 0-42, lower score meaning a better outcome
measure: Flourishing Scale (FS-D)
time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
description: Assessing full scale, range 8-56, higher score meaning a better outcome
measure: Freiburg Mindfulness Inventory (FMI)
time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
description: Assessing full scale, range 0-56, higher score meaning a better outcome
measure: Insomnia Severity Index (ISI)
time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
description: Assessing full scale, range 0-28, lower score meaning a better outcome
measure: Self-Efficacy Scale - Short Form (ASKU)
time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
description: mean score of the 3 items, range 1-5
measure: Self-Compassion Scale (SCS-D)
time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
description: mean score of 12 items, range 1-5, higher score meaning a better outcome
measure: Behavioral questions: alcohol consumption
time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
description: Number of alcoholic beverages on average per week in the last month
measure: Behavioral questions: relaxation
time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
description: Relaxation behavior on average per week in the last month in minutes
measure: Behavioral questions: cigarettes
time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
description: Number of cigarettes on average per week in the last month in minutes
measure: Sociodemographic Measurements
time frame: Date of inclusion (baseline)
description: Age, gender, education level, household income, employment status, marital status, complete family history, current and previous diseases and co-morbidities, current medication intake
measure: Body weight
time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
description: kg
measure: Expectation questions
time frame: Date of inclusion (baseline)
description: For intervention 1 and intervention 2 on a 5-point likert scale from 1 (nothing at all) to 5 (very strong)
measure: Behavioral questions: sport
time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
description: Sports behavior on average per week in the last month in minutes
measure: Qualitative interviews
time frame: 12 weeks and 24 weeks after inclusion
description: Qualitative assessment will be carried out in qualitative interviews in 20 patients participating in the study. The interviews will be recorded, transcribed and analyzed with qualitative content analysis.
arm group label: Outdoor
arm group type: Experimental
description: Nature-centered therapy in a near-natural area
arm group label: Indoor
arm group type: Active Comparator
description: Conventional therapy in rooms mainly in a hospital building
intervention type: Behavioral
intervention name: Nature-near integrative day care unit programme
description: Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme
arm group label: Outdoor
intervention type: Behavioral
intervention name: Conventional integrative day care unit programme
description: Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme
arm group label: Indoor
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Andreas Michalsen
investigator title: Prof. Dr. med.
mesh term: Neoplasms
sharing ipd: Yes