<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/NCT03786198</url>
  </required_header>
  <id_info>
    <org_study_id>SAKK 95/17</org_study_id>
    <nct_id>NCT03786198</nct_id>
  </id_info>
  <brief_title>Activity Program During Aromatase Inhibitor Therapy</brief_title>
  <official_title>A 24 Weeks Activity Program in Patients With Early Breast Cancer Receiving Aromatase Inhibitor Therapy. A Multicenter Randomized Phase III Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Group for Clinical Cancer Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Swiss Group for Clinical Cancer Research</source>
  <oversight_info>
    <has_dmc>Yes</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 primary aim of the trial is to investigate if a simple outdoor walking intervention,&#xD;
      which is practicable under real-life conditions, beginning at the start of adjuvant aromatase&#xD;
      inhibitor (AI) therapy, can prevent the occurrence of muscle or joint pain/stiffness in&#xD;
      breast cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After tumor removal, patients with hormone receptor positive breast cancer tumors often&#xD;
      receive adjuvant endocrine treatment, with the use of an aromatase inhibitor (AI) being&#xD;
      standard of care in the population of postmenopausal women. Common side effects of AI therapy&#xD;
      are joint pain, muscle pain, stiffness, fatigue, hot flashes, and weight gain. Arthralgia&#xD;
      and/or myalgia can result in lower physical activity and can negatively influence quality of&#xD;
      life (QoL). In addition, muscle or joint pain/stiffness are among the main reasons for&#xD;
      non-compliance and discontinuation of AI therapy. Because AI therapy is usually administered&#xD;
      for 5 and sometimes even 10 years, this is a major clinical challenge.&#xD;
&#xD;
      For breast cancer patients undergoing AI therapy, physical activity can provide potential&#xD;
      benefit by reducing muscle/joint pain and fatigue and can thus improve QoL. The preventive&#xD;
      effect of physical activity on AI side effects, however, remains elusive. In addition,&#xD;
      activity programs to reduce AI side effects have so far mostly been rather complex. The&#xD;
      primary aim of the trial is to investigate if a simple outdoor walking intervention, which is&#xD;
      practicable under real-life conditions, beginning at the start of adjuvant AI therapy, can&#xD;
      prevent the occurrence of muscle or joint pain/stiffness in breast cancer patients.&#xD;
&#xD;
      Furthermore, this trial will assess the effect of physical activity on symptom burden in&#xD;
      general and quality of life in patients receiving adjuvant AI therapy. During the follow-up&#xD;
      phase, the trial will assess whether this intervention leads to a sustained change in&#xD;
      lifestyle regarding activity, less pain, and better treatment adherence in the intervention&#xD;
      group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 28, 2019</start_date>
  <completion_date type="Actual">June 8, 2023</completion_date>
  <primary_completion_date type="Actual">September 27, 2021</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>Home-based walking intervention for 24 weeks + standard adjuvant AI therapy&#xD;
Physical activity according to standard recommendations for 24 weeks + standard adjuvant AI therapy</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of muscle or joint pain/stiffness as measured by BPI-SF single-item worst pain score</measure>
    <time_frame>Up to 24 weeks after randomization</time_frame>
    <description>Muscle or joint pain/stiffness will be assessed at baseline, 3, 9, 12, 15, 18, 21, 24 weeks after randomization by the BPI-SF questionnaire.&#xD;
The BPI-SF is a 14-item self-administered questionnaire which is routinely used in clinical trials to assess pain severity and pain interference with daily activities in patients with cancer. Pain severity is assessed by four items including pain at its &quot;worst&quot;, &quot;least&quot;, &quot;average&quot; in the last 24 hours and &quot;now&quot; (current pain), each item being rated on a 0-10 scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>Baseline, 12 and 24 weeks and 1 and 2 years after randomization</time_frame>
    <description>Fatigue will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QoL: Physical scale (EORTC QLQ-C30)</measure>
    <time_frame>Baseline, 12 and 24 weeks and 1 and 2 years after randomization</time_frame>
    <description>Physical scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QoL: Rose scale (EORTC QLQ-C30)</measure>
    <time_frame>Baseline, 12 and 24 weeks and 1 and 2 years after randomization</time_frame>
    <description>Role scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QoL: Emotional scale (EORTC QLQ-C30)</measure>
    <time_frame>Baseline, 12 and 24 weeks and 1 and 2 years after randomization</time_frame>
    <description>Emotional scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QoL: Cognitive scale (EORTC QLQ-C30)</measure>
    <time_frame>Baseline, 12 and 24 weeks and 1 and 2 years after randomization</time_frame>
    <description>Cognitive scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QoL: Social functioning scale (EORTC QLQ-C30)</measure>
    <time_frame>Baseline, 12 and 24 weeks and 1 and 2 years after randomization</time_frame>
    <description>Cognitive scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea/Vomiting</measure>
    <time_frame>Baseline, 12 and 24 weeks and 1 and 2 years after randomization</time_frame>
    <description>Nausea/vomiting will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain (EORTC QLQ-C30)</measure>
    <time_frame>Baseline, 12 and 24 weeks and 1 and 2 years after randomization</time_frame>
    <description>Pain will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global health status</measure>
    <time_frame>Baseline, 12 and 24 weeks and 1 and 2 years after randomization</time_frame>
    <description>Global health status will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspnoea</measure>
    <time_frame>Baseline, 12 and 24 weeks and 1 and 2 years after randomization</time_frame>
    <description>Dyspnoea will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia</measure>
    <time_frame>Baseline, 12 and 24 weeks and 1 and 2 years after randomization</time_frame>
    <description>Insomnia will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite loss</measure>
    <time_frame>Baseline, 12 and 24 weeks and 1 and 2 years after randomization</time_frame>
    <description>Appetite loss will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Constipation</measure>
    <time_frame>Baseline, 12 and 24 weeks and 1 and 2 years after randomization</time_frame>
    <description>Constipation will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diarrhoea</measure>
    <time_frame>Baseline, 12 and 24 weeks and 1 and 2 years after randomization</time_frame>
    <description>Diarrhoea will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Financial difficulties</measure>
    <time_frame>Baseline, 12 and 24 weeks and 1 and 2 years after randomization</time_frame>
    <description>Financial difficulties will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hot flashes</measure>
    <time_frame>Baseline, 12 and 24 weeks and 1 and 2 years after randomization</time_frame>
    <description>Hot flashes will be assessed at baseline, during intervention phase and during follow-up phase via the item 37 of the EORTC QLQ BR-23.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of muscle or joint pain/stiffness and its impact on everyday functioning</measure>
    <time_frame>Baseline, 3, 9, 12, 15, 18, 21, 24 weeks and 1, 2 years after randomization</time_frame>
    <description>Severity of muscle or joint pain/stiffness will be measured by the four BPI pain severity items. Pain interference will be calculated as the mean of the seven interference items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking activity</measure>
    <time_frame>Baseline, 3, 9, 12, 15, 18, 21, 24 weeks after randomization</time_frame>
    <description>During trial intervention phase, daily steps will be measured by a wrist worn activity tracker.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AI treatment adherence (diary)</measure>
    <time_frame>Baseline, 3, 9, 12, 15, 18, 21, 24 weeks.</time_frame>
    <description>Adherence will be assessed by patient self-report (diary).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AI treatment adherence (questionnaire)</measure>
    <time_frame>Baseline, 12, 24 weeks and 1, 2 years after randomization</time_frame>
    <description>Adherence will be assessed by patient self-report (questionnaire completed at visits).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">375</enrollment>
  <condition>Early Breast Cancer</condition>
  <arm_group>
    <arm_group_label>a) Home-based walking intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks + standard adjuvant AI therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>b) Physical activity according to standard recommendations</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Physical activity according to standard recommendations, wearing a wrist worn activity tracker (with no feedback about performed activity), for 24 weeks + standard adjuvant AI therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Activity program</intervention_name>
    <description>Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks</description>
    <arm_group_label>a) Home-based walking intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Physical activity according to standard recommendations, wearing a wrist worn activity tracker (with no feedback about performed activity), for 24 weeks + standard adjuvant AI therapy</description>
    <arm_group_label>b) Physical activity according to standard recommendations</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent according to Swiss law and ICH/GCP regulations before&#xD;
             registration and prior to any trial specific procedures.&#xD;
&#xD;
          -  Histologically confirmed hormone-receptor-positive newly diagnosed breast cancer, AJCC&#xD;
             (American Joint Committee on Cancer) stage I-III&#xD;
&#xD;
          -  Patient had tumor removal by breast conserving surgery or mastectomy, followed by&#xD;
             chemotherapy (if indicated) and/or radiotherapy (if indicated)&#xD;
&#xD;
          -  Patient is starting adjuvant first-line endocrine treatment with an AI alone (in&#xD;
             postmenopausal women) or combined endocrine treatment with an AI and ovarian&#xD;
             suppression with an LHRH-agonist (in premenopausal women)&#xD;
&#xD;
          -  Patient completed the PRO Form Eligibility before registration&#xD;
&#xD;
          -  Patient is fluent in German, Italian, or French&#xD;
&#xD;
          -  Patient is willing to wear a wrist worn activity tracker for 24 weeks&#xD;
&#xD;
          -  Female patient, age ≥ 18 years&#xD;
&#xD;
          -  WHO performance status 0-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing severe medical conditions such as heart or lung problems or&#xD;
             musculoskeletal conditions precluding participation in the physical activity program&#xD;
             of moderate walking a total of 150 minutes per week as determined by the local&#xD;
             investigator&#xD;
&#xD;
          -  Mild, moderate, or severe pain (other than post-operative pain) in the last 24 hours&#xD;
             due to muscle/joint pain on the BPI-SF single item &quot;worst pain&quot; (&quot;worst pain&quot; ≥3)&#xD;
             within 7 days prior to registration&#xD;
&#xD;
          -  Inoperable, locally advanced and/or metastatic breast cancer&#xD;
&#xD;
          -  Active rheumatoid arthritis&#xD;
&#xD;
          -  Neoadjuvant endocrine treatment with an AI&#xD;
&#xD;
          -  NSAIDs, acetaminophen or opioids on a regular basis (&gt; 1 time per week)&#xD;
&#xD;
          -  Concurrent participation in other clinical trials or observational studies&#xD;
&#xD;
          -  Any other serious psychological, familial or geographical condition, which in the&#xD;
             judgment of the investigator may interfere with the intervention and follow-up or&#xD;
             affect patient compliance with trial procedures.&#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>Friedemann Honecker, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Tumor- und Brustzentrum ZeTuP St.Gallen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nicolette Hoefnagels, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Tumor- und Brustzentrum ZeTuP St.Gallen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kantonsspital Aarau</name>
      <address>
        <city>Aarau</city>
        <zip>5001</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Baden</name>
      <address>
        <city>Baden</city>
        <zip>5404</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CABA - Zentrum für Onkologie, Psychologie und Bewegung</name>
      <address>
        <city>Basel</city>
        <zip>4051</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brustzentrum Basel - Praxis für ambulante Tumortherapie</name>
      <address>
        <city>Basel</city>
        <zip>4052</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsspital Basel</name>
      <address>
        <city>Basel</city>
        <zip>CH-4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inselspital Bern</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hirslanden Brustzentrum Bern Biel</name>
      <address>
        <city>Bern</city>
        <zip>3013</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Graubünden</name>
      <address>
        <city>Chur</city>
        <zip>7000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tumorzentrum ZeTuP Chur</name>
      <address>
        <city>Chur</city>
        <zip>7000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique des Grangettes, Centre du sein</name>
      <address>
        <city>Chêne-Bougeries</city>
        <zip>1224</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brustzentrum Thurgau</name>
      <address>
        <city>Frauenfeld</city>
        <zip>8501</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre du sein Fribourg / Brustzentrum Freiburg</name>
      <address>
        <city>Fribourg</city>
        <zip>1700</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique De Genolier</name>
      <address>
        <city>Genolier</city>
        <zip>1272</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FOLM - Fondazione Oncologia Lago Maggiore</name>
      <address>
        <city>Locarno</city>
        <zip>6600</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncologia Varini&amp;Calderoni&amp;Christinat</name>
      <address>
        <city>Lugano</city>
        <zip>6900</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Luzern</name>
      <address>
        <city>Luzerne</city>
        <zip>CH-6000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hirslanden Klinik St. Anna</name>
      <address>
        <city>Luzern</city>
        <zip>6006</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onkologie Zentrum Spital Männedorf</name>
      <address>
        <city>Manno</city>
        <zip>8708</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli</name>
      <address>
        <city>Mendrisio</city>
        <zip>6850</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Neuchâtelois</name>
      <address>
        <city>Neuenhof</city>
        <zip>2000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Olten</name>
      <address>
        <city>Olten</city>
        <zip>4600</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tumorzentrum ZeTuP Rapperswil-Jona</name>
      <address>
        <city>Rapperswil-Jona</city>
        <zip>8640</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brustzentrum Ostschweiz</name>
      <address>
        <city>Saint Gallen</city>
        <zip>9016</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rundum Onkologie am Bahnhofpark</name>
      <address>
        <city>Sargans</city>
        <zip>7320</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de Sion</name>
      <address>
        <city>Sion</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tumorzentrum ZeTUP</name>
      <address>
        <city>St. Gallen</city>
        <zip>9006</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital St. Gallen</name>
      <address>
        <city>St. Gallen</city>
        <zip>CH-9007</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regionalspital Thun</name>
      <address>
        <city>Thun</city>
        <zip>3600</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Winterthur, Brustzentrum</name>
      <address>
        <city>Winterthur</city>
        <zip>8401</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onkologie Bellevue</name>
      <address>
        <city>Zurich</city>
        <zip>8001</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brustzentrum Zürich</name>
      <address>
        <city>Zürich</city>
        <zip>8008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitäts Spital Zürich</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>June 26, 2023</last_update_submitted>
  <last_update_submitted_qc>June 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>early breast cancer</keyword>
  <keyword>aromatase inhibitor therapy</keyword>
  <keyword>activity program</keyword>
  <keyword>physical activity</keyword>
  <keyword>activity tracker</keyword>
  <keyword>pedometer</keyword>
  <keyword>stepcounter</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/NCT03786198
org study id: SAKK 95/17
nct id: NCT03786198
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary aim of the trial is to investigate if a simple outdoor walking intervention,
      which is practicable under real-life conditions, beginning at the start of adjuvant aromatase
      inhibitor (AI) therapy, can prevent the occurrence of muscle or joint pain/stiffness in
      breast cancer patients.
After tumor removal, patients with hormone receptor positive breast cancer tumors often
      receive adjuvant endocrine treatment, with the use of an aromatase inhibitor (AI) being
      standard of care in the population of postmenopausal women. Common side effects of AI therapy
      are joint pain, muscle pain, stiffness, fatigue, hot flashes, and weight gain. Arthralgia
      and/or myalgia can result in lower physical activity and can negatively influence quality of
      life (QoL). In addition, muscle or joint pain/stiffness are among the main reasons for
      non-compliance and discontinuation of AI therapy. Because AI therapy is usually administered
      for 5 and sometimes even 10 years, this is a major clinical challenge.

      For breast cancer patients undergoing AI therapy, physical activity can provide potential
      benefit by reducing muscle/joint pain and fatigue and can thus improve QoL. The preventive
      effect of physical activity on AI side effects, however, remains elusive. In addition,
      activity programs to reduce AI side effects have so far mostly been rather complex. The
      primary aim of the trial is to investigate if a simple outdoor walking intervention, which is
      practicable under real-life conditions, beginning at the start of adjuvant AI therapy, can
      prevent the occurrence of muscle or joint pain/stiffness in breast cancer patients.

      Furthermore, this trial will assess the effect of physical activity on symptom burden in
      general and quality of life in patients receiving adjuvant AI therapy. During the follow-up
      phase, the trial will assess whether this intervention leads to a sustained change in
      lifestyle regarding activity, less pain, and better treatment adherence in the intervention
      group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Home-based walking intervention for 24 weeks + standard adjuvant AI therapy
Physical activity according to standard recommendations for 24 weeks + standard adjuvant AI therapy
primary purpose: Supportive Care
masking: None (Open Label)
measure: Incidence of muscle or joint pain/stiffness as measured by BPI-SF single-item worst pain score
time frame: Up to 24 weeks after randomization
description: Muscle or joint pain/stiffness will be assessed at baseline, 3, 9, 12, 15, 18, 21, 24 weeks after randomization by the BPI-SF questionnaire.
The BPI-SF is a 14-item self-administered questionnaire which is routinely used in clinical trials to assess pain severity and pain interference with daily activities in patients with cancer. Pain severity is assessed by four items including pain at its "worst", "least", "average" in the last 24 hours and "now" (current pain), each item being rated on a 0-10 scale.
measure: Fatigue
time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
description: Fatigue will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.
measure: QoL: Physical scale (EORTC QLQ-C30)
time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
description: Physical scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.
measure: QoL: Rose scale (EORTC QLQ-C30)
time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
description: Role scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.
measure: QoL: Emotional scale (EORTC QLQ-C30)
time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
description: Emotional scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.
measure: QoL: Cognitive scale (EORTC QLQ-C30)
time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
description: Cognitive scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.
measure: QoL: Social functioning scale (EORTC QLQ-C30)
time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
description: Cognitive scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.
measure: Nausea/Vomiting
time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
description: Nausea/vomiting will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.
measure: Pain (EORTC QLQ-C30)
time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
description: Pain will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.
measure: Global health status
time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
description: Global health status will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.
measure: Dyspnoea
time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
description: Dyspnoea will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.
measure: Insomnia
time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
description: Insomnia will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.
measure: Appetite loss
time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
description: Appetite loss will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.
measure: Constipation
time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
description: Constipation will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.
measure: Diarrhoea
time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
description: Diarrhoea will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.
measure: Financial difficulties
time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
description: Financial difficulties will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0.
measure: Hot flashes
time frame: Baseline, 12 and 24 weeks and 1 and 2 years after randomization
description: Hot flashes will be assessed at baseline, during intervention phase and during follow-up phase via the item 37 of the EORTC QLQ BR-23.
measure: Intensity of muscle or joint pain/stiffness and its impact on everyday functioning
time frame: Baseline, 3, 9, 12, 15, 18, 21, 24 weeks and 1, 2 years after randomization
description: Severity of muscle or joint pain/stiffness will be measured by the four BPI pain severity items. Pain interference will be calculated as the mean of the seven interference items.
measure: Walking activity
time frame: Baseline, 3, 9, 12, 15, 18, 21, 24 weeks after randomization
description: During trial intervention phase, daily steps will be measured by a wrist worn activity tracker.
measure: AI treatment adherence (diary)
time frame: Baseline, 3, 9, 12, 15, 18, 21, 24 weeks.
description: Adherence will be assessed by patient self-report (diary).
measure: AI treatment adherence (questionnaire)
time frame: Baseline, 12, 24 weeks and 1, 2 years after randomization
description: Adherence will be assessed by patient self-report (questionnaire completed at visits).
arm group label: a) Home-based walking intervention
arm group type: Experimental
description: Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks + standard adjuvant AI therapy
arm group label: b) Physical activity according to standard recommendations
arm group type: Active Comparator
description: Physical activity according to standard recommendations, wearing a wrist worn activity tracker (with no feedback about performed activity), for 24 weeks + standard adjuvant AI therapy
intervention type: Behavioral
intervention name: Activity program
description: Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks
arm group label: a) Home-based walking intervention
intervention type: Behavioral
intervention name: Control
description: Physical activity according to standard recommendations, wearing a wrist worn activity tracker (with no feedback about performed activity), for 24 weeks + standard adjuvant AI therapy
arm group label: b) Physical activity according to standard recommendations
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Friedemann Honecker, MD
role: Study Chair
affiliation: Tumor- und Brustzentrum ZeTuP St.Gallen
last name: Nicolette Hoefnagels, MSc
role: Study Chair
affiliation: Tumor- und Brustzentrum ZeTuP St.Gallen
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country: Switzerland
responsible party type: Sponsor
mesh term: Breast Neoplasms