<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/NCT04433793</url>
  </required_header>
  <id_info>
    <org_study_id>DRKS00016034</org_study_id>
    <nct_id>NCT04433793</nct_id>
  </id_info>
  <brief_title>Yoga Intervention for Reducing Fatigue in Cancer Patients</brief_title>
  <acronym>Carfi</acronym>
  <official_title>Yoga Intervention and Reminder E-mails for Reducing Cancer-related Fatigue - a Study Protocol of a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wuerzburg University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>German Cancer Aid</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wuerzburg University Hospital</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>
      Cancer patients suffer from severe exhaustion and tiredness that is disproportionate to&#xD;
      previous efforts and that cannot be completely reduced by sleep. The effectiveness of an 8&#xD;
      week yoga therapy (one hour a week) in patients with different cancer types on self-reported&#xD;
      fatigue will be tested.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Almost 90% of cancer patients suffer from symptoms of fatigue during treatment. Supporting&#xD;
      treatments are increasingly used to alleviate the burden of fatigue. This study examines the&#xD;
      short-term effects of yoga on fatigue, depression and quality of life. The aim of this study&#xD;
      will evaluate the efficacy of yoga for cancer patients with mixed diagnoses reporting&#xD;
      fatigue. We will randomly allocate 124 patients to an intervention group (N=62) receiving&#xD;
      yoga and a wait-list control group (N=62) receiving yoga 9 weeks later. The yoga therapy will&#xD;
      be performed in weekly sessions of 60 minutes each for 8 weeks. The primary outcome will be&#xD;
      self-reported fatigue symptoms. Secondary outcome will be depression and Quality of life&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 12, 2018</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 16, 2020</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>A randomized controlled trial with cancer patients suffering from fatigue is planned. The study investigates the efficacy in terms of fatigue, depression and quality of life of eight-week yoga therapy (intervention group) compared to an 8-week waiting period without supportive intervention (control group).</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from self-reported fatigue after participation in yoga therapy.</measure>
    <time_frame>T0: At the beginning of the study, T1: after 9 weeks</time_frame>
    <description>Self-reported cancer related fatigue; measured with: European Organisation for Research and Treatment of Cancer - Quality of life Questionnaire - Fatigue 13 (EORTC-QLQ-FA13); Scale 1-4; Higher scores mean a higher burden of fatigue</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from Quality of life in cancer patients</measure>
    <time_frame>T0: At the beginning of the study, T1: after 9 weeks</time_frame>
    <description>self-reported Quality of life in cancer patients, measured with European Organisation for Research and Treatment of Cancer - Quality of life Questionnaire -Cancer 15 Palliativ (EORTC-QLQ-C15-Pal); Item 1- 14: Scale 1-4; Higher scores represent lower quality of life, Item 15: Scale 1-7; a higher value represents higher Overall Quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from Depression</measure>
    <time_frame>T0: At the beginning of the study, T1: after 9 weeks</time_frame>
    <description>self reported Depression, measured with patient health questionnaire -9 (PHQ-9); Scale: 1-4; higher score represents higher burden of depression</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">167</enrollment>
  <condition>Fatigue</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Yoga group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the yoga group will receive yoga therapy, one hour every week for eight weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist-control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the waitlist-control group will receive no intervention at first, but nine weeks after IG, they will get the opportunity to also receive yoga therapy for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga therapy</intervention_name>
    <description>One yoga session will last one hour. It consists of physical exercises (asanas), conscious breathing (Pranayama) and deep relaxation (Savasana). The subsequent body exercises are structured from lying to sitting to standing. The following sequence of exercises will be repeated in each yoga unit: 1) Relaxation: conscious breathing, body scan, mindfulness 2) Vein pump 3) Pelvis and back rotation (adapted variation of the &quot;nakrasana&quot;) 4) Pelvis opening (adapted variation of the &quot;supta baddha konasana&quot;) 5) Shoulder bridge (&quot;setu bandha sarvangasana) 6) Forward folds (Paschimottanasana and variations with Pranayama) 7) Backbend: intense east stretch (Purvottasana) 8) Diagonal static yoga cat (Majariasana 1 and resting pose) 9) Standing exercise 10) Upward Salute(Urdhva Hastasana) 11) Warrior 1 (Virabhadrasana 1) 12) Warrior 3 (Virabhadrasana 3) 13) Tree (Vrkasana variation) 14) Relaxation (Savasana).</description>
    <arm_group_label>Yoga group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  oncological disease&#xD;
&#xD;
          -  planned to undergo cancer related treatment at radiotherapy outpatient clinic or the&#xD;
             interdisciplinary oncological therapy outpatient clinic&#xD;
&#xD;
          -  reported fatigue symptoms: (intensity ≥4, impairment ≥ 5).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  insufficient knowledge of German&#xD;
&#xD;
          -  severe emotional or physical impairment&#xD;
&#xD;
          -  more than 50km distance to the university hospital which would require travelling.&#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>Universitätsklinikum Würzburg, Interdisciplinary Centre, Palliativ Medicine</name>
      <address>
        <city>Würzburg</city>
        <state>Bayern</state>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Zetzl T, Schuler M, Renner A, Jentschke E, van Oorschot B. Yoga intervention and reminder e-mails for reducing cancer-related fatigue - a study protocol of a randomized controlled trial. BMC Psychol. 2019 Sep 18;7(1):64. doi: 10.1186/s40359-019-0339-3.</citation>
    <PMID>31533823</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Yoga</keyword>
  <keyword>Mindfulness based Intervention</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Cancer Patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>all individual participant data that underlie results in publication (demographics and clinical characteristics, fatigue, Depression and Quality of life)</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>starting 6 months after publication for 1 year</ipd_time_frame>
    <ipd_access_criteria>for comparisons of efficacy of different yoga styles or supportive therapy in cancer patients</ipd_access_criteria>
  </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/NCT04433793
org study id: DRKS00016034
nct id: NCT04433793
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cancer patients suffer from severe exhaustion and tiredness that is disproportionate to
      previous efforts and that cannot be completely reduced by sleep. The effectiveness of an 8
      week yoga therapy (one hour a week) in patients with different cancer types on self-reported
      fatigue will be tested.
Almost 90% of cancer patients suffer from symptoms of fatigue during treatment. Supporting
      treatments are increasingly used to alleviate the burden of fatigue. This study examines the
      short-term effects of yoga on fatigue, depression and quality of life. The aim of this study
      will evaluate the efficacy of yoga for cancer patients with mixed diagnoses reporting
      fatigue. We will randomly allocate 124 patients to an intervention group (N=62) receiving
      yoga and a wait-list control group (N=62) receiving yoga 9 weeks later. The yoga therapy will
      be performed in weekly sessions of 60 minutes each for 8 weeks. The primary outcome will be
      self-reported fatigue symptoms. Secondary outcome will be depression and Quality of life
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomized controlled trial with cancer patients suffering from fatigue is planned. The study investigates the efficacy in terms of fatigue, depression and quality of life of eight-week yoga therapy (intervention group) compared to an 8-week waiting period without supportive intervention (control group).
primary purpose: Supportive Care
masking: Single (Care Provider)
measure: Changes from self-reported fatigue after participation in yoga therapy.
time frame: T0: At the beginning of the study, T1: after 9 weeks
description: Self-reported cancer related fatigue; measured with: European Organisation for Research and Treatment of Cancer - Quality of life Questionnaire - Fatigue 13 (EORTC-QLQ-FA13); Scale 1-4; Higher scores mean a higher burden of fatigue
measure: Changes from Quality of life in cancer patients
time frame: T0: At the beginning of the study, T1: after 9 weeks
description: self-reported Quality of life in cancer patients, measured with European Organisation for Research and Treatment of Cancer - Quality of life Questionnaire -Cancer 15 Palliativ (EORTC-QLQ-C15-Pal); Item 1- 14: Scale 1-4; Higher scores represent lower quality of life, Item 15: Scale 1-7; a higher value represents higher Overall Quality of life
measure: Changes from Depression
time frame: T0: At the beginning of the study, T1: after 9 weeks
description: self reported Depression, measured with patient health questionnaire -9 (PHQ-9); Scale: 1-4; higher score represents higher burden of depression
arm group label: Yoga group
arm group type: Experimental
description: Patients in the yoga group will receive yoga therapy, one hour every week for eight weeks.
arm group label: Waitlist-control group
arm group type: No Intervention
description: Patients in the waitlist-control group will receive no intervention at first, but nine weeks after IG, they will get the opportunity to also receive yoga therapy for 8 weeks.
intervention type: Behavioral
intervention name: Yoga therapy
description: One yoga session will last one hour. It consists of physical exercises (asanas), conscious breathing (Pranayama) and deep relaxation (Savasana). The subsequent body exercises are structured from lying to sitting to standing. The following sequence of exercises will be repeated in each yoga unit: 1) Relaxation: conscious breathing, body scan, mindfulness 2) Vein pump 3) Pelvis and back rotation (adapted variation of the "nakrasana") 4) Pelvis opening (adapted variation of the "supta baddha konasana") 5) Shoulder bridge ("setu bandha sarvangasana) 6) Forward folds (Paschimottanasana and variations with Pranayama) 7) Backbend: intense east stretch (Purvottasana) 8) Diagonal static yoga cat (Majariasana 1 and resting pose) 9) Standing exercise 10) Upward Salute(Urdhva Hastasana) 11) Warrior 1 (Virabhadrasana 1) 12) Warrior 3 (Virabhadrasana 3) 13) Tree (Vrkasana variation) 14) Relaxation (Savasana).
arm group label: Yoga group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
citation: Zetzl T, Schuler M, Renner A, Jentschke E, van Oorschot B. Yoga intervention and reminder e-mails for reducing cancer-related fatigue - a study protocol of a randomized controlled trial. BMC Psychol. 2019 Sep 18;7(1):64. doi: 10.1186/s40359-019-0339-3.
PMID: 31533823
responsible party type: Sponsor
mesh term: Fatigue
sharing ipd: Yes
ipd description: all individual participant data that underlie results in publication (demographics and clinical characteristics, fatigue, Depression and Quality of life)
ipd info type: Study Protocol
ipd info type: Analytic Code
ipd time frame: starting 6 months after publication for 1 year
ipd access criteria: for comparisons of efficacy of different yoga styles or supportive therapy in cancer patients