<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/NCT02246907</url>
  </required_header>
  <id_info>
    <org_study_id>LCCC1234</org_study_id>
    <nct_id>NCT02246907</nct_id>
  </id_info>
  <brief_title>Exercise and Quality of Life in Leukemia Patients</brief_title>
  <acronym>EQUAL</acronym>
  <official_title>Effects of Exercise on Patient Reported Outcomes in Newly Diagnosed Adults With Acute Leukemia During Induction Treatment: Exercise and Quality of Life in Leukemia Patients (EQUAL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNC Lineberger Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UNC Lineberger Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the impact of an exercise intervention on&#xD;
      patient-reported anxiety, depression, fatigue, and sleep disturbances among acute leukemia&#xD;
      patients. The investigators hypothesize that exercise will reduce fatigue in acute leukemia&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this randomized, prospective, longitudinal study is to evaluate the impact of&#xD;
      an exercise intervention on patient-reported anxiety, depression, fatigue, and sleep&#xD;
      disturbances outcomes among acute leukemia patients. The study will include 2 groups for a&#xD;
      total sample size of 30: n=15 control group and n=15 intervention group. Each patient&#xD;
      enrolled in the intervention arm will participate in an exercise program for the duration of&#xD;
      their hospitalization, 4-6 weeks on average during the first treatment (induction&#xD;
      chemotherapy).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Compare symptoms of fatigue in newly diagnosed acute leukemia patients</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 weeks</time_frame>
    <description>Symptoms will be assessed by patient reported survey at baseline, weekly through patient hospitalization, and then again at patient's first appointment after hospital discharge. We are interested in how the symptom changes over time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate health-related quality of life changes over time</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 weeks</time_frame>
    <description>Health related quality of life will be assessed by patient reported survey at baseline, and at the week 4 timepoint. We are interested in change over time between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare symptoms of anxiety between groups</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 weeks</time_frame>
    <description>Symptoms will be assessed by patient reported survey at baseline, weekly during hospitalization, and at first clinic visit after discharge from hospital. We are interested in change over time between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare symptoms of depression between groups</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 weeks</time_frame>
    <description>Symptoms will be assessed by patient reported survey at baseline, weekly during hospitalization, and at first clinic visit after discharge from hospital. We are interested in change over time between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare sleep quality between groups</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 weeks</time_frame>
    <description>Symptoms will be assessed by patient reported survey at baseline, weekly during hospitalization, and at first clinic visit after discharge from hospital. We are interested in change over time between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in cardiovascular function</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 weeks</time_frame>
    <description>Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in muscle strength</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 weeks</time_frame>
    <description>Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body composition</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 weeks</time_frame>
    <description>Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in functional mobility</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 weeks</time_frame>
    <description>Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in muscle size</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 weeks</time_frame>
    <description>Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Acute Leukemia</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive standard of care which includes recreational therapy and standard encouragement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants in this arm will receive standard of care plus exercise for the duration of their inpatient stay for induction chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>All intervention patients will participate in an individualized prescriptive exercise intervention 2 to 4 times per week for a period of the induction chemotherapy/in-hospital recovery. The exercise intervention will begin on week 1 of the study, the day after the first batteries of initial assessments are concluded. Each exercise session will be divided into two parts. One part will be administered in the morning and the second one late in the afternoon. There will be a period of rest of at least 36 hours between each exercise session.</description>
    <arm_group_label>Exercise</arm_group_label>
    <other_name>Exercise and Quality of Life in Acute Leukemia Patients</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed with acute leukemia by pathology report&#xD;
&#xD;
          -  Admitted for induction chemotherapy within in the previous 96 hours or +/- 3 days from&#xD;
             initiation of induction chemotherapy&#xD;
&#xD;
          -  An expected hospital stay of 3-4 weeks or longer&#xD;
&#xD;
          -  Participation in the study must be approved by the physician directly responsible for&#xD;
             the patient's care while at University of North Carolina -Hospitals&#xD;
&#xD;
          -  Age &gt;21 years of age&#xD;
&#xD;
          -  Willing and able to provide, signed informed consent&#xD;
&#xD;
          -  Willing and able to use a computer to complete study questionnaires&#xD;
&#xD;
          -  Ability to understand and speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The criteria below will be determined by the patient's physician and a review of the&#xD;
        patient's medical history. If any of the exclusion criteria are observed, the patients will&#xD;
        be informed and excluded from participating in the study.&#xD;
&#xD;
        Participation in this study will involve the same risks as any exercise regimen. Given the&#xD;
        potential risks involved, patients will be screened for exclusion based upon the following&#xD;
        criteria:&#xD;
&#xD;
          -  Cardiovascular disease (unless the disease would not compromise the patient's ability&#xD;
             to participate in the exercise rehabilitation program)&#xD;
&#xD;
          -  Acute or chronic respiratory disease that would compromise the patient's ability to&#xD;
             participate in the exercise rehabilitation program&#xD;
&#xD;
          -  Acute or chronic bone, joint, or muscular abnormalities that would compromise the&#xD;
             patient's ability to participate in the exercise rehabilitation program&#xD;
&#xD;
          -  Inability to understand and speak English&#xD;
&#xD;
          -  Dementia, altered mental status, or any psychiatric condition that would prohibit the&#xD;
             understanding or rendering of informed consent&#xD;
&#xD;
          -  Another active malignancy&#xD;
&#xD;
          -  Patients will also be excluded if they have active bleeding, acute thrombosis,&#xD;
             ischemia, hemodynamically unstable, and uncontrolled pain.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ashley Bryant, PhD, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNC- Chapel Hill</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Claudio Battaglini, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNC- Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina Lineberger Comprehenisive Cancer Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>March 27, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>November 22, 2016</last_update_submitted>
  <last_update_submitted_qc>November 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Health related quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</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/NCT02246907
org study id: LCCC1234
nct id: NCT02246907
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the impact of an exercise intervention on
      patient-reported anxiety, depression, fatigue, and sleep disturbances among acute leukemia
      patients. The investigators hypothesize that exercise will reduce fatigue in acute leukemia
      patients.
The purpose of this randomized, prospective, longitudinal study is to evaluate the impact of
      an exercise intervention on patient-reported anxiety, depression, fatigue, and sleep
      disturbances outcomes among acute leukemia patients. The study will include 2 groups for a
      total sample size of 30: n=15 control group and n=15 intervention group. Each patient
      enrolled in the intervention arm will participate in an exercise program for the duration of
      their hospitalization, 4-6 weeks on average during the first treatment (induction
      chemotherapy).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Compare symptoms of fatigue in newly diagnosed acute leukemia patients
time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
description: Symptoms will be assessed by patient reported survey at baseline, weekly through patient hospitalization, and then again at patient's first appointment after hospital discharge. We are interested in how the symptom changes over time.
measure: Evaluate health-related quality of life changes over time
time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
description: Health related quality of life will be assessed by patient reported survey at baseline, and at the week 4 timepoint. We are interested in change over time between groups
measure: Compare symptoms of anxiety between groups
time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
description: Symptoms will be assessed by patient reported survey at baseline, weekly during hospitalization, and at first clinic visit after discharge from hospital. We are interested in change over time between groups.
measure: Compare symptoms of depression between groups
time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
description: Symptoms will be assessed by patient reported survey at baseline, weekly during hospitalization, and at first clinic visit after discharge from hospital. We are interested in change over time between groups.
measure: Compare sleep quality between groups
time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
description: Symptoms will be assessed by patient reported survey at baseline, weekly during hospitalization, and at first clinic visit after discharge from hospital. We are interested in change over time between groups.
measure: Changes in cardiovascular function
time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
description: Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.
measure: Changes in muscle strength
time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
description: Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.
measure: Changes in body composition
time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
description: Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.
measure: Changes in functional mobility
time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
description: Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.
measure: Changes in muscle size
time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
description: Exercise testing which will assess the outcome measures will be performed at baseline, and after 4 weeks of training (for the intervention group), or at the week 4 time point (for the control group). We are interested in change over time between groups.
arm group label: Control Group
arm group type: No Intervention
description: The control group will receive standard of care which includes recreational therapy and standard encouragement.
arm group label: Exercise
arm group type: Other
description: Participants in this arm will receive standard of care plus exercise for the duration of their inpatient stay for induction chemotherapy.
intervention type: Other
intervention name: Exercise
description: All intervention patients will participate in an individualized prescriptive exercise intervention 2 to 4 times per week for a period of the induction chemotherapy/in-hospital recovery. The exercise intervention will begin on week 1 of the study, the day after the first batteries of initial assessments are concluded. Each exercise session will be divided into two parts. One part will be administered in the morning and the second one late in the afternoon. There will be a period of rest of at least 36 hours between each exercise session.
arm group label: Exercise
other name: Exercise and Quality of Life in Acute Leukemia Patients
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Ashley Bryant, PhD, RN
role: Principal Investigator
affiliation: UNC- Chapel Hill
last name: Claudio Battaglini, PhD
role: Principal Investigator
affiliation: UNC- Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Leukemia