<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/NCT04506476</url>
  </required_header>
  <id_info>
    <org_study_id>OnkoFit I</org_study_id>
    <nct_id>NCT04506476</nct_id>
  </id_info>
  <brief_title>Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Adjuvant Radiotherapy of Breast Cancer</brief_title>
  <acronym>OnkoFit I</acronym>
  <official_title>Randomisierte Studie Zum Nutzen Des Fitnesstracker Basierten Aktivitätstrainings während Einer Adjuvanten Bestrahlung Des Mammakarzinoms (OnkoFit I)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Tuebingen</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 randomized three-arm trial will test the benefit in terms of cancer related fatigue of&#xD;
      an activity tracker based exercise training during adjuvant radiotherapy in breast cancer&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This monocentric, three-arm, randomized, controlled clinical trial evaluates the effect of an&#xD;
      activity tracker based exercise program in breast cancer patients on the fatigue syndrome&#xD;
      during adjuvant radiotherapy. Quality of Life and the intensity of fatigue will be documented&#xD;
      with the fatigue subscale of the FACIT Questionnaire three months after adjuvant&#xD;
      radiotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">August 1, 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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the impact of an activity tracker based fitness programme on the fatigue syndrome</measure>
    <time_frame>3 Months after completion of adjuvant radiotherapy of breast cancer</time_frame>
    <description>This endpoint will be evaluated by the FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) subscale of the FACIT questionnaire (Physical well-being values 0-28, 28 worse outcome; social/family well-being values 0-28, 28 better outcome; emotional well-being values 0-24, 24 worse outcome; functional well being values 0-28, 28 better outcome; additional factors values 0-64, 64 worse outcome</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">201</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Activity tracker with weekly goals</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive a fitness tracker, a booklet &quot;Physical training, exercise and cancer&quot; and an in-person briefing on physical activity during cancer therapy. We suggest a daily step-count which should improve the patients physical activity during radiotherapy of breast cancer. Patients receive weekly feedback and a new goal with the aim to reach a total of 6000 daily steps, which should be then maintained during radiotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Activity tracker without Weekly goals</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive a fitness tracker, a booklet &quot;Physical training, exercise and cancer&quot; and an in-person briefing on physical activity during cancer therapy.&#xD;
The patients self-document their daily step count during radiotherapy, there will be no recommendation for the daily count of steps.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm with no activity tracker</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients receive a booklet &quot;Physical training, exercise and cancer&quot; and an in-person briefing on physical activity during cancer therapy. A fitness tracker will not be provided.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fitness tracker based activity training for Arm A and B. Booklet &quot;physical training, exercise and cancer&quot; and an introduction about physical activity during cancer therapy for Arm A, B, C</intervention_name>
    <description>Patients receive a fitness tracker, a booklet &quot;Physical training, exercise and cancer&quot; and an in-person briefing about physical activity during cancer therapy. With offered guidelines for the daily step counts patients should improve their physical activity during radiotherapy of breast cancer. A weekly feedback and a new goal for the next week will be provided until the individual patient reaches a daily activity of 6000 steps. The setting will be to maintain to this daily activity of 6000 steps during radiotherapy.</description>
    <arm_group_label>Activity tracker with weekly goals</arm_group_label>
    <arm_group_label>Activity tracker without Weekly goals</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Capacity for consent&#xD;
&#xD;
          -  Minimum age 18&#xD;
&#xD;
          -  Presence of breast cancer&#xD;
&#xD;
          -  ECOG 0-2&#xD;
&#xD;
          -  Indication for adjuvant radiotherapy of breast cancer after breast-conserving surgery&#xD;
             or Ablatio mammae&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in any other interventional study&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Contraindication against physical activity/sport and others&#xD;
&#xD;
          -  Severe cardiovascular pre-existing conditions (after myocardial infarction, apoplexy&#xD;
             in the last 6 months, congestive heart failure NYHA &gt; I°)&#xD;
&#xD;
          -  preexisting diseases with are relevantly accompanied by a limited mobility in patients&#xD;
             (e.g. paraparesis of the lower limbs)&#xD;
&#xD;
          -  ECOG Status 3-4&#xD;
&#xD;
          -  prior use of activity trackers&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cihan Gani, MD, PD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Tübingen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cihan Gani, MD, PD</last_name>
    <phone>+49 (0) 7071 29-82165</phone>
    <email>cihan.gani@med.uni-tuebingen.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Daniel Zips, MD, Prof</last_name>
    <phone>+49 (0) 7071 29-82165</phone>
    <email>ro-info@med.uni-tuebingen.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital Tübingen, Department of Radiation Oncology</name>
      <address>
        <city>Tübingen</city>
        <state>Baden-Württemberg</state>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel Zips, MD, Prof</last_name>
      <phone>+49 (0) 7071 29-85990</phone>
      <email>ro-info@med.uni-tuebingen.de</email>
    </contact>
    <contact_backup>
      <last_name>Cihan Gani, MD</last_name>
      <phone>+49 (0)7071 29-82165</phone>
      <email>cihan.gani@med.uni-tuebingen.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 13, 2020</last_update_submitted>
  <last_update_submitted_qc>August 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Tuebingen</investigator_affiliation>
    <investigator_full_name>Dr. Cihan Gani</investigator_full_name>
    <investigator_title>Senior Physician</investigator_title>
  </responsible_party>
  <keyword>Fatigue</keyword>
  <keyword>activity tracker</keyword>
  <keyword>Radiotherapy</keyword>
  <keyword>Exercise</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/NCT04506476
org study id: OnkoFit I
nct id: NCT04506476
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized three-arm trial will test the benefit in terms of cancer related fatigue of
      an activity tracker based exercise training during adjuvant radiotherapy in breast cancer
      patients.
This monocentric, three-arm, randomized, controlled clinical trial evaluates the effect of an
      activity tracker based exercise program in breast cancer patients on the fatigue syndrome
      during adjuvant radiotherapy. Quality of Life and the intensity of fatigue will be documented
      with the fatigue subscale of the FACIT Questionnaire three months after adjuvant
      radiotherapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Evaluation of the impact of an activity tracker based fitness programme on the fatigue syndrome
time frame: 3 Months after completion of adjuvant radiotherapy of breast cancer
description: This endpoint will be evaluated by the FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) subscale of the FACIT questionnaire (Physical well-being values 0-28, 28 worse outcome; social/family well-being values 0-28, 28 better outcome; emotional well-being values 0-24, 24 worse outcome; functional well being values 0-28, 28 better outcome; additional factors values 0-64, 64 worse outcome
arm group label: Activity tracker with weekly goals
arm group type: Experimental
description: Patients receive a fitness tracker, a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy. We suggest a daily step-count which should improve the patients physical activity during radiotherapy of breast cancer. Patients receive weekly feedback and a new goal with the aim to reach a total of 6000 daily steps, which should be then maintained during radiotherapy.
arm group label: Activity tracker without Weekly goals
arm group type: Experimental
description: Patients receive a fitness tracker, a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy.
The patients self-document their daily step count during radiotherapy, there will be no recommendation for the daily count of steps.
arm group label: Control arm with no activity tracker
arm group type: No Intervention
description: Patients receive a booklet "Physical training, exercise and cancer" and an in-person briefing on physical activity during cancer therapy. A fitness tracker will not be provided.
intervention type: Device
intervention name: Fitness tracker based activity training for Arm A and B. Booklet "physical training, exercise and cancer" and an introduction about physical activity during cancer therapy for Arm A, B, C
description: Patients receive a fitness tracker, a booklet "Physical training, exercise and cancer" and an in-person briefing about physical activity during cancer therapy. With offered guidelines for the daily step counts patients should improve their physical activity during radiotherapy of breast cancer. A weekly feedback and a new goal for the next week will be provided until the individual patient reaches a daily activity of 6000 steps. The setting will be to maintain to this daily activity of 6000 steps during radiotherapy.
arm group label: Activity tracker with weekly goals
arm group label: Activity tracker without Weekly goals
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cihan Gani, MD, PD
role: Principal Investigator
affiliation: University Hospital Tübingen
last name: Cihan Gani, MD, PD
phone: +49 (0) 7071 29-82165
email: cihan.gani@med.uni-tuebingen.de
last name: Daniel Zips, MD, Prof
phone: +49 (0) 7071 29-82165
email: ro-info@med.uni-tuebingen.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Tuebingen
investigator full name: Dr. Cihan Gani
investigator title: Senior Physician
mesh term: Breast Neoplasms