<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/NCT01685346</url>
  </required_header>
  <id_info>
    <org_study_id>CASE6512</org_study_id>
    <secondary_id>12-874</secondary_id>
    <nct_id>NCT01685346</nct_id>
  </id_info>
  <brief_title>Biofeedback Training in Patients With Advanced Lung Cancer - A Pilot Study</brief_title>
  <official_title>Biofeedback Training in Patients With Advanced Lung Cancer - A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study to test the hypothesis that biofeedback-mediated stress management&#xD;
      (BFSM) training can be used to reduce distress and enhance quality of life in patients with&#xD;
      non-small cell lung cancer (NSCLC). Most patients with advanced NSCLC have significant&#xD;
      physical symptoms, but even those who do not have physical symptoms have high levels of&#xD;
      anxiety and depression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Biofeedback-mediated stress management (BFSM) involves helping patients to visualize the&#xD;
      reactions which their own bodies have to stressful situations (increased heart rate,&#xD;
      increased skin conductance, increased muscle tension, decreased digital peripheral&#xD;
      temperature, decreased heart rate variability) and then teaching them to control these&#xD;
      reactions, using standard stress management and relaxation techniques, coupled with&#xD;
      computerized physiological feedback. The feedback helps patients to understand that deep&#xD;
      relaxation is helping their bodies as well as their minds. Several small studies of BFSM&#xD;
      training in cancer populations have been successful at helping with side effects of&#xD;
      chemotherapy and radiation, but the effects of BFSM on distress and quality of life (QOL),&#xD;
      particularly in NSCLC patients, have not been studied.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Research Cancelled&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients that are able to return for eight visits of BFSM</measure>
    <time_frame>16 weeks</time_frame>
    <description>Keep track of how many visits the patients attend, how many they cancel, and what other difficulties are encounter in getting them to return for eight visits.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients able to complete the Quality of Life (QOL) questionnaires</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess changes in distress thermometer from baseline</measure>
    <time_frame>16 weeks</time_frame>
    <description>Distress Thermometer questionnaire using a scale of 0-10. O meaning no distress and 10 meaning extreme distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on the FACT-lung questionnaire</measure>
    <time_frame>16 weeks</time_frame>
    <description>Physical, social/family, emotional, and functional well-being on a 0-4 scale. O being not at all and 4 being very much.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of the Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Questionnaire to determine the levels of anxiety and depression that a patient is experiencing. The HADS is a fourteen item scale that generates ordinal data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of the Patient Health Questionnaire (PHQ-*8)</measure>
    <time_frame>16 weeks</time_frame>
    <description>8-Item depression health questionnaire based on a scale from 0-3. 0 meaning not at all and 3 meaning nearly every day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baseline of digital peripheral temperature</measure>
    <time_frame>16 weeks</time_frame>
    <description>Compare the baseline measurement during the first five minutes of the session, the peak response to mental stress during the next ten minutes of the session, and the response during the self-relaxation period following the mental stress. An improvement would indicate success with biofeedback.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baseline of skin conductance</measure>
    <time_frame>16 weeks</time_frame>
    <description>Compare the baseline measurement during the first five minutes of the session, the peak response to mental stress during the next ten minutes of the session, and the response during the self-relaxation period following the mental stress. An improvement would indicate success with biofeedback.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of Electromyography (EMG)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Compare the baseline measurement during the first five minutes of the session, the peak response to mental stress during the next ten minutes of the session, and the response during the self-relaxation period following the mental stress. An improvement would indicate success with biofeedback.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of respiratory rates</measure>
    <time_frame>16 weeks</time_frame>
    <description>Compare the baseline measurement during the first five minutes of the session, the peak response to mental stress during the next ten minutes of the session, and the response during the self-relaxation period following the mental stress. An improvement would indicate success with biofeedback.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of heart rates</measure>
    <time_frame>16 weeks</time_frame>
    <description>Compare the baseline measurement during the first five minutes of the session, the peak response to mental stress during the next ten minutes of the session, and the response during the self-relaxation period following the mental stress. An improvement would indicate success with biofeedback.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Advanced (Stage IV) Non-small Cell Lung Cancer (NSCLC)</condition>
  <arm_group>
    <arm_group_label>Biofeedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>biofeedback-mediated stress management (BFSM)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>biofeedback-mediated stress management (BFSM)</intervention_name>
    <description>Therapist and study assistant meet with patient, attach sensors, record physiologic variables and train the patient in relaxation techniques including deep breathing, guided imagery, progressive muscle relaxation, autogenics. Patient is given a handheld thermometer to take home and practice self-regulation between visits, along with a recording sheet to indicate how often practice occurs.</description>
    <arm_group_label>Biofeedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a new diagnosis of advanced (stage IV) non-small cell lung cancer&#xD;
             (NSCLC)&#xD;
&#xD;
          -  ECOG performance status 0-1.&#xD;
&#xD;
          -  Plan to receive care at the Taussig Cancer Center.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-local patients, who will not have the ability to return for 8 study visits.&#xD;
&#xD;
          -  Patients who are unable to speak and understand English readily,&#xD;
&#xD;
          -  Patients with significant cognitive impairment.&#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>Nathan Pennell, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>July 9, 2015</last_update_submitted>
  <last_update_submitted_qc>July 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>advanced (stage IV) non-small cell lung cancer (NSCLC)</keyword>
  <keyword>biofeedback-mediated stress management (BFSM)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</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/NCT01685346
org study id: CASE6512
secondary id: 12-874
nct id: NCT01685346
lead sponsor: 
has dmc: Yes
This is a pilot study to test the hypothesis that biofeedback-mediated stress management
      (BFSM) training can be used to reduce distress and enhance quality of life in patients with
      non-small cell lung cancer (NSCLC). Most patients with advanced NSCLC have significant
      physical symptoms, but even those who do not have physical symptoms have high levels of
      anxiety and depression.
Biofeedback-mediated stress management (BFSM) involves helping patients to visualize the
      reactions which their own bodies have to stressful situations (increased heart rate,
      increased skin conductance, increased muscle tension, decreased digital peripheral
      temperature, decreased heart rate variability) and then teaching them to control these
      reactions, using standard stress management and relaxation techniques, coupled with
      computerized physiological feedback. The feedback helps patients to understand that deep
      relaxation is helping their bodies as well as their minds. Several small studies of BFSM
      training in cancer populations have been successful at helping with side effects of
      chemotherapy and radiation, but the effects of BFSM on distress and quality of life (QOL),
      particularly in NSCLC patients, have not been studied.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of patients that are able to return for eight visits of BFSM
time frame: 16 weeks
description: Keep track of how many visits the patients attend, how many they cancel, and what other difficulties are encounter in getting them to return for eight visits.
measure: Number of patients able to complete the Quality of Life (QOL) questionnaires
time frame: 16 weeks
measure: Assess changes in distress thermometer from baseline
time frame: 16 weeks
description: Distress Thermometer questionnaire using a scale of 0-10. O meaning no distress and 10 meaning extreme distress.
measure: Change from baseline on the FACT-lung questionnaire
time frame: 16 weeks
description: Physical, social/family, emotional, and functional well-being on a 0-4 scale. O being not at all and 4 being very much.
measure: Change from baseline of the Hospital Anxiety and Depression Scale (HADS)
time frame: 16 weeks
description: Questionnaire to determine the levels of anxiety and depression that a patient is experiencing. The HADS is a fourteen item scale that generates ordinal data.
measure: Change from baseline of the Patient Health Questionnaire (PHQ-*8)
time frame: 16 weeks
description: 8-Item depression health questionnaire based on a scale from 0-3. 0 meaning not at all and 3 meaning nearly every day.
measure: Change in baseline of digital peripheral temperature
time frame: 16 weeks
description: Compare the baseline measurement during the first five minutes of the session, the peak response to mental stress during the next ten minutes of the session, and the response during the self-relaxation period following the mental stress. An improvement would indicate success with biofeedback.
measure: Change in baseline of skin conductance
time frame: 16 weeks
description: Compare the baseline measurement during the first five minutes of the session, the peak response to mental stress during the next ten minutes of the session, and the response during the self-relaxation period following the mental stress. An improvement would indicate success with biofeedback.
measure: Change from baseline of Electromyography (EMG)
time frame: 16 weeks
description: Compare the baseline measurement during the first five minutes of the session, the peak response to mental stress during the next ten minutes of the session, and the response during the self-relaxation period following the mental stress. An improvement would indicate success with biofeedback.
measure: Change from baseline of respiratory rates
time frame: 16 weeks
description: Compare the baseline measurement during the first five minutes of the session, the peak response to mental stress during the next ten minutes of the session, and the response during the self-relaxation period following the mental stress. An improvement would indicate success with biofeedback.
measure: Change from baseline of heart rates
time frame: 16 weeks
description: Compare the baseline measurement during the first five minutes of the session, the peak response to mental stress during the next ten minutes of the session, and the response during the self-relaxation period following the mental stress. An improvement would indicate success with biofeedback.
arm group label: Biofeedback
arm group type: Experimental
description: biofeedback-mediated stress management (BFSM)
intervention type: Behavioral
intervention name: biofeedback-mediated stress management (BFSM)
description: Therapist and study assistant meet with patient, attach sensors, record physiologic variables and train the patient in relaxation techniques including deep breathing, guided imagery, progressive muscle relaxation, autogenics. Patient is given a handheld thermometer to take home and practice self-regulation between visits, along with a recording sheet to indicate how often practice occurs.
arm group label: Biofeedback
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nathan Pennell, MD
role: Principal Investigator
affiliation: Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung