<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/NCT03824860</url>
  </required_header>
  <id_info>
    <org_study_id>18-578</org_study_id>
    <nct_id>NCT03824860</nct_id>
  </id_info>
  <brief_title>Yoga for Painful Chemotherapy-Induced Peripheral Neuropathy: A Pilot, Randomized-Controlled Study</brief_title>
  <official_title>Yoga for Painful Chemotherapy-Induced Peripheral Neuropathy: A Pilot, Randomized-Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oncology Nursing Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dana-Farber Cancer Institute</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 research study will examine the feasibility of conducting an eight-week yoga&#xD;
      intervention for individuals with chronic painful chemotherapy-induced peripheral neuropathy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research study will examine the feasibility of conducting an eight-week yoga&#xD;
      intervention for individuals with chronic painful chemotherapy-induced peripheral neuropathy.&#xD;
      The investigators will also explore participants' perceptions of acceptability and&#xD;
      satisfaction with the yoga intervention. Lastly, the investigators will examine changes in&#xD;
      chemotherapy-induced peripheral neuropathy severity, physical function, sleep-related&#xD;
      impairment, fatigue, anxiety, depression, and pain following the eight-week yoga&#xD;
      intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 6, 2019</start_date>
  <completion_date type="Actual">February 18, 2021</completion_date>
  <primary_completion_date type="Actual">February 8, 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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants recruited to participate in the study</measure>
    <time_frame>From enrollment to end of treatment at 8 weeks.</time_frame>
    <description>Feasibility of participant recruitment to the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of yoga practice by participants</measure>
    <time_frame>From enrollment to end of treatment at 8 weeks.</time_frame>
    <description>Feasibility of participant adherence to the yoga intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of outcome assessments completed by participants.</measure>
    <time_frame>From enrollment to end of treatment at 8 weeks.</time_frame>
    <description>Feasibility of participant adherence to outcome assessments</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability and Satisfaction with Participation in Yoga Intervention</measure>
    <time_frame>At the end of treatment, 8 weeks after enrollment</time_frame>
    <description>We will use semi-structured interviews to gain information about participants' experience with the yoga program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Worst Chemotherapy-Induced Peripheral Neuropathy Pain Intensity</measure>
    <time_frame>At the time of enrollment and at the end of treatment, 8 weeks after enrollment</time_frame>
    <description>Change in 0 - 10 numerical rating scale of worst chemotherapy-induced peripheral neuropathy pain (via 7-day pain diary) from enrollment to end of treatment at 8 weeks. Total scores range from 0 - 10, with higher scores representing worse pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemotherapy-Induced Peripheral Neuropathy Severity</measure>
    <time_frame>From enrollment to end of treatment at 8 weeks.At the time of enrollment and at the end of treatment, 8 weeks after enrollment</time_frame>
    <description>Change in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale-20 score from enrollment to end of treatment at 8 weeks. Total scores range from 0 - 100, with higher scores representing worse chemotherapy-induced peripheral neuropathy severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Interference</measure>
    <time_frame>At the time of enrollment and at the end of treatment, 8 weeks after enrollment</time_frame>
    <description>Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 41.6 - 75.6, with higher scores representing worse pain interference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep-Related Impairment</measure>
    <time_frame>At the time of enrollment and at the end of treatment, 8 weeks after enrollment</time_frame>
    <description>Change in Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment 8a score from enrollment to the end of treatment at 8 weeks. Total scores range from 30.0 - 80.1 with higher scores representing worse sleep-related impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety assessed by the &quot;Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety&quot;</measure>
    <time_frame>At the time of enrollment and at the end of treatment, 8 weeks after enrollment</time_frame>
    <description>Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 40.3 - 81.6, with higher scores representing worse anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression assessed by Change in Patient Reported Outcomes Measurement Information System (PROMIS) Depression</measure>
    <time_frame>At the time of enrollment and at the end of treatment, 8 weeks after enrollment</time_frame>
    <description>Change in Patient Reported Outcomes Measurement Information System (PROMIS) Depression 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 41.0 - 79.4, with higher scores representing worse depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue assessed by Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue</measure>
    <time_frame>At the time of enrollment and at the end of treatment, 8 weeks after enrollment</time_frame>
    <description>Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 33.7 - 75.8, with higher scores representing worse fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Function</measure>
    <time_frame>At the time of enrollment and at the end of treatment, at 8 weeks.</time_frame>
    <description>Change in Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 22.5 - 57.0, with higher scores representing better physical function.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Chemotherapy-induced Peripheral Neuropathy</condition>
  <condition>Yoga</condition>
  <condition>Chronic Pain</condition>
  <condition>Neuropathic Pain</condition>
  <arm_group>
    <arm_group_label>Yoga Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eight-weeks, therapist and self-guided yoga</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group participants will continue to receive usual care and symptom management strategies from clinicians during the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga</intervention_name>
    <description>Participants will attend at least one group class per week (in-person or Zoom) and practice one self-guided yoga video class at home on their own per week, over eight weeks&#xD;
Participants may choose to attend &quot;Flow Yoga&quot; and/or &quot;Chair Flow Yoga&quot; classes. These classes will be videotaped and made available to participants electronically.&#xD;
Classes consist of:&#xD;
guided breathing exercises,&#xD;
upper and lower extremity stretching&#xD;
structured postures and movements to improve balance and strength</description>
    <arm_group_label>Yoga Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -≥18 years of age,&#xD;
&#xD;
          -  self-report ≥ 4/10 worst chemotherapy-induced peripheral neuropathy pain over the past&#xD;
             week,&#xD;
&#xD;
          -  at least three months post neurotoxic chemotherapy completion&#xD;
&#xD;
          -  signed informed consent,&#xD;
&#xD;
          -  willingness to participate in all study activities&#xD;
&#xD;
          -  speak/read English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prognosis of less than three months,&#xD;
&#xD;
          -  documented peripheral neuropathy due to other causes (e.g., diabetes),&#xD;
&#xD;
          -  planned receipt of neurotoxic chemotherapy during the study period,&#xD;
&#xD;
          -  practice yoga &gt;45 minutes per week over the past six months,&#xD;
&#xD;
          -  diagnosis or documented recent history of significant psychiatric comorbidity (i.e.,&#xD;
             psychosis, suicidal ideation, or substance abuse)&#xD;
&#xD;
          -  clinician deems that the patient is physically/functionally unable to participate in a&#xD;
             yoga program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Knoerl, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dana-Farber Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>March 25, 2022</last_update_submitted>
  <last_update_submitted_qc>March 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Robert Knoerl, PhD, RN</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Chemotherapy-induced Peripheral Neuropathy</keyword>
  <keyword>Yoga</keyword>
  <keyword>Chronic Pain</keyword>
  <keyword>Neuropathic Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Robert Knoerl, PhD; Study PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication</ipd_time_frame>
    <ipd_access_criteria>Brigham and Women's Hospital - Contact the Partners Innovations team at http://www.partners.org/innovation</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 19, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT03824860/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03824860
org study id: 18-578
nct id: NCT03824860
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research study will examine the feasibility of conducting an eight-week yoga
      intervention for individuals with chronic painful chemotherapy-induced peripheral neuropathy.
This research study will examine the feasibility of conducting an eight-week yoga
      intervention for individuals with chronic painful chemotherapy-induced peripheral neuropathy.
      The investigators will also explore participants' perceptions of acceptability and
      satisfaction with the yoga intervention. Lastly, the investigators will examine changes in
      chemotherapy-induced peripheral neuropathy severity, physical function, sleep-related
      impairment, fatigue, anxiety, depression, and pain following the eight-week yoga
      intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of participants recruited to participate in the study
time frame: From enrollment to end of treatment at 8 weeks.
description: Feasibility of participant recruitment to the study
measure: Frequency of yoga practice by participants
time frame: From enrollment to end of treatment at 8 weeks.
description: Feasibility of participant adherence to the yoga intervention
measure: Frequency of outcome assessments completed by participants.
time frame: From enrollment to end of treatment at 8 weeks.
description: Feasibility of participant adherence to outcome assessments
measure: Acceptability and Satisfaction with Participation in Yoga Intervention
time frame: At the end of treatment, 8 weeks after enrollment
description: We will use semi-structured interviews to gain information about participants' experience with the yoga program
measure: Worst Chemotherapy-Induced Peripheral Neuropathy Pain Intensity
time frame: At the time of enrollment and at the end of treatment, 8 weeks after enrollment
description: Change in 0 - 10 numerical rating scale of worst chemotherapy-induced peripheral neuropathy pain (via 7-day pain diary) from enrollment to end of treatment at 8 weeks. Total scores range from 0 - 10, with higher scores representing worse pain.
measure: Chemotherapy-Induced Peripheral Neuropathy Severity
time frame: From enrollment to end of treatment at 8 weeks.At the time of enrollment and at the end of treatment, 8 weeks after enrollment
description: Change in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale-20 score from enrollment to end of treatment at 8 weeks. Total scores range from 0 - 100, with higher scores representing worse chemotherapy-induced peripheral neuropathy severity.
measure: Pain Interference
time frame: At the time of enrollment and at the end of treatment, 8 weeks after enrollment
description: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 41.6 - 75.6, with higher scores representing worse pain interference.
measure: Sleep-Related Impairment
time frame: At the time of enrollment and at the end of treatment, 8 weeks after enrollment
description: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment 8a score from enrollment to the end of treatment at 8 weeks. Total scores range from 30.0 - 80.1 with higher scores representing worse sleep-related impairment.
measure: Anxiety assessed by the "Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety"
time frame: At the time of enrollment and at the end of treatment, 8 weeks after enrollment
description: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 40.3 - 81.6, with higher scores representing worse anxiety.
measure: Depression assessed by Change in Patient Reported Outcomes Measurement Information System (PROMIS) Depression
time frame: At the time of enrollment and at the end of treatment, 8 weeks after enrollment
description: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Depression 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 41.0 - 79.4, with higher scores representing worse depression.
measure: Fatigue assessed by Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue
time frame: At the time of enrollment and at the end of treatment, 8 weeks after enrollment
description: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 33.7 - 75.8, with higher scores representing worse fatigue.
measure: Physical Function
time frame: At the time of enrollment and at the end of treatment, at 8 weeks.
description: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 22.5 - 57.0, with higher scores representing better physical function.
arm group label: Yoga Program
arm group type: Experimental
description: Eight-weeks, therapist and self-guided yoga
arm group label: Treatment as usual
arm group type: No Intervention
description: Control group participants will continue to receive usual care and symptom management strategies from clinicians during the study.
intervention type: Behavioral
intervention name: Yoga
description: Participants will attend at least one group class per week (in-person or Zoom) and practice one self-guided yoga video class at home on their own per week, over eight weeks
Participants may choose to attend "Flow Yoga" and/or "Chair Flow Yoga" classes. These classes will be videotaped and made available to participants electronically.
Classes consist of:
guided breathing exercises,
upper and lower extremity stretching
structured postures and movements to improve balance and strength
arm group label: Yoga Program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Knoerl, PhD
role: Principal Investigator
affiliation: Dana-Farber Cancer Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Robert Knoerl, PhD, RN
investigator title: Principal Investigator
mesh term: Peripheral Nervous System Diseases
mesh term: Neuralgia
mesh term: Chronic Pain
sharing ipd: Yes
ipd description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Robert Knoerl, PhD; Study PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data can be shared no earlier than 1 year following the date of publication
ipd access criteria: Brigham and Women's Hospital - Contact the Partners Innovations team at http://www.partners.org/innovation
provided document: 