<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/NCT01669109</url>
  </required_header>
  <id_info>
    <org_study_id>12-4957-BO</org_study_id>
    <nct_id>NCT01669109</nct_id>
  </id_info>
  <brief_title>Hatha Yoga for Patients With Colorectal Cancer</brief_title>
  <acronym>YoCo</acronym>
  <official_title>Hatha Yoga for Patients With Colorectal Cancer - a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universität Duisburg-Essen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universität Duisburg-Essen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hatha Yoga is a traditional practice that encompasses aerobic exercise, breathing techniques,&#xD;
      and meditation. It is used in India since centuries to improve well-being and cope with&#xD;
      diseases and is gaining more and more interest in Europe and the US. While studies have&#xD;
      demonstrated benefits of Hatha Yoga for patients with breast cancer, no studies on patients&#xD;
      with colorectal cancer are available yet. The purpose of this study is to investigate the&#xD;
      effect of Hatha Yoga in patients with colorectal cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>Week 10</time_frame>
    <description>Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>Week 22</time_frame>
    <description>- Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>Week 10, week 22</time_frame>
    <description>Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety, depression</measure>
    <time_frame>Week 10, week 22</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>Week 10, week 22</time_frame>
    <description>Pittsburgh Sleep Quality Index (PSQI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>Week 0-22</time_frame>
    <description>Number and severity of adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spiritual well-being</measure>
    <time_frame>Week 10, week 22</time_frame>
    <description>- Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Body awareness/bodily dissociation</measure>
    <time_frame>Week 10, week 22</time_frame>
    <description>Scale of Body Connection (SBC)&#xD;
Used in mediation analysis</description>
  </other_outcome>
  <other_outcome>
    <measure>Body efficacy expectation</measure>
    <time_frame>Week 10, week 22</time_frame>
    <description>Body Efficacy-Expectation Scale&#xD;
Used in mediation analysis</description>
  </other_outcome>
  <other_outcome>
    <measure>Qualitative Interviews</measure>
    <time_frame>Week 11</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Colorectal Neoplasms</condition>
  <arm_group>
    <arm_group_label>Hatha yoga</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 weeks of Hatha yoga, designed for patients with colorectal cancer, as a group intervention&#xD;
1 weekly class (90 minutes)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients continue their self-directed usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Hatha yoga</intervention_name>
    <arm_group_label>Hatha yoga</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Colorectal cancer&#xD;
&#xD;
          -  UICC stage I-III&#xD;
&#xD;
          -  between 2 and 48 months post-surgery&#xD;
&#xD;
          -  age at least 18 years&#xD;
&#xD;
          -  physical and cognitive ability to follow the yoga intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  UICC stage IV&#xD;
&#xD;
          -  further active oncological diseases&#xD;
&#xD;
          -  diagnosed and pharmacologically treated psychiatric disorder except for cancer-related&#xD;
             depression or adjustment disorder&#xD;
&#xD;
          -  pregnancy or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Internal and Complementary Medicine, Immanuel Hospital Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>14109</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department for Internal and Integrative Medicine, Essen-Mitte Clinics</name>
      <address>
        <city>Essen</city>
        <zip>45276</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>January 9, 2014</last_update_submitted>
  <last_update_submitted_qc>January 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universität Duisburg-Essen</investigator_affiliation>
    <investigator_full_name>Holger Cramer</investigator_full_name>
    <investigator_title>Postdoctoral fellow</investigator_title>
  </responsible_party>
  <keyword>Yoga</keyword>
  <keyword>Colorectal Neoplasms</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Randomized Controlled Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal 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/NCT01669109
org study id: 12-4957-BO
nct id: NCT01669109
lead sponsor: 
has dmc: No
Hatha Yoga is a traditional practice that encompasses aerobic exercise, breathing techniques,
      and meditation. It is used in India since centuries to improve well-being and cope with
      diseases and is gaining more and more interest in Europe and the US. While studies have
      demonstrated benefits of Hatha Yoga for patients with breast cancer, no studies on patients
      with colorectal cancer are available yet. The purpose of this study is to investigate the
      effect of Hatha Yoga in patients with colorectal cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Health-related quality of life
time frame: Week 10
description: Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C)
measure: Health-related quality of life
time frame: Week 22
description: - Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C)
measure: Fatigue
time frame: Week 10, week 22
description: Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
measure: Anxiety, depression
time frame: Week 10, week 22
description: Hospital Anxiety and Depression Scale (HADS)
measure: Sleep quality
time frame: Week 10, week 22
description: Pittsburgh Sleep Quality Index (PSQI)
measure: Safety
time frame: Week 0-22
description: Number and severity of adverse events
measure: Spiritual well-being
time frame: Week 10, week 22
description: - Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp)
measure: Body awareness/bodily dissociation
time frame: Week 10, week 22
description: Scale of Body Connection (SBC)
Used in mediation analysis
measure: Body efficacy expectation
time frame: Week 10, week 22
description: Body Efficacy-Expectation Scale
Used in mediation analysis
measure: Qualitative Interviews
time frame: Week 11
arm group label: Hatha yoga
arm group type: Experimental
description: 10 weeks of Hatha yoga, designed for patients with colorectal cancer, as a group intervention
1 weekly class (90 minutes)
arm group label: Usual care
arm group type: No Intervention
description: Patients continue their self-directed usual care
intervention type: Behavioral
intervention name: Hatha yoga
arm group label: Hatha yoga
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Universität Duisburg-Essen
investigator full name: Holger Cramer
investigator title: Postdoctoral fellow
mesh term: Colorectal Neoplasms