<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/NCT03027063</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00110810</org_study_id>
    <nct_id>NCT03027063</nct_id>
  </id_info>
  <brief_title>Impact of Exercise on Mitigating the Cardio-toxic Effects of Adriamycin Among Women Newly Diagnosed With Breast Cancer.</brief_title>
  <official_title>Impact of Exercise on Mitigating the Cardio-toxic Effects of Adriamycin Among Women Newly Diagnosed With Breast Cancer Who Will be Treated With Anthracyclines</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research is being done to determine whether exercise while receiving doxorubicin or&#xD;
      Adriamycin chemotherapy for breast cancer can reduce the cardio-toxic effects of this&#xD;
      treatment on the heart and improve other outcomes related to cancer such as tumor markers,&#xD;
      nausea, fatigue and the ability to tolerate chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a pilot study that looks at the effect of exercise, while receiving&#xD;
      anthracycline therapy, on mitigating the cardio toxic effects of anthracyclines as assessed&#xD;
      by serial echocardiographic strain analysis.&#xD;
&#xD;
      Potential participants will be identified during chart review in advance of a routine clinic&#xD;
      visit or during a routine clinic visit with a provider. Individuals will be approached by the&#xD;
      provider or study team to determine willingness to learn more about a study for which they&#xD;
      may be eligible. Discussions regarding study participation will take place privately and&#xD;
      individuals will be provided with the Institutional Review Board (IRB) approved consent form.&#xD;
&#xD;
      In addition, potential participants may contact the study team directly. This contact may be&#xD;
      in the form of telephone, email, etc. Initial discussions regarding study participation may&#xD;
      take place by phone, email, etc., and individuals may be provided with the IRB approved&#xD;
      consent form and other IRB reviewed and approved materials (e.g., Patient Handout), as&#xD;
      applicable.&#xD;
&#xD;
      In all cases, as much time as is needed to consider study participation will be allowed to&#xD;
      possible participants; resulting in multiple phone calls, visits, emails, or other&#xD;
      communication, as necessary. For individuals who choose to take part, informed consent will&#xD;
      happen as per the consent process.&#xD;
&#xD;
      Patients will be recruited from the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center,&#xD;
      Sibley Memorial Hospital and the community. The investigators anticipate that among roughly&#xD;
      60 subjects approached for enrollment, 30 will be part of the final study. Participants who&#xD;
      agree to participate will be asked to provide written consent. Participants will be&#xD;
      randomized by an online system to one of the following two groups in a 1:2 ratio. Group&#xD;
      1(Usual care group) will receive a fitness tracker and flyers that reference the American&#xD;
      College of Cardiology/American Heart Association (ACC/AHA) guidelines for exercise and&#xD;
      physical activity for the general population. In addition to fitness tracker and flyers,&#xD;
      Group 2 (10,000 steps group) will receive additional messages and phone calls for motivation.&#xD;
      This group of participants will also be asked to take part in 30 minutes of continuous&#xD;
      exercise daily as part of their intervention.&#xD;
&#xD;
      For motivation, messages will be sent to study participants in group 2 via the messaging&#xD;
      center in the Under Armour application three times a week. With the application, study&#xD;
      participant will receive a phone alert and an email message to which they may respond if&#xD;
      needed. The frequency of messaging will be increased for participants who fail to meet their&#xD;
      goals for three consecutive days. In addition to the Under Armour application, participants&#xD;
      will be provided with a log sheet for recording their daily steps, whether 30 minutes of&#xD;
      continuous activity daily was completed and the type of the activity done for the 30 minutes.&#xD;
      Group two study subjects will also receive a weekly call to assess for side effects and&#xD;
      provide additional encouragement. Log sheets will be collected during oncology clinic visits&#xD;
      and the aforementioned intervention will be continued for the duration of their chemotherapy&#xD;
      treatment. Group 1 study participants will be assessed for side effects through a phone call&#xD;
      every 4 weeks.&#xD;
&#xD;
      For the study, women will be given an Under Armour band that will monitor daily steps, amount&#xD;
      of sleep and heart rate. Participants will be asked to download the Under Armour application&#xD;
      to their mobile phones so the data from their bands can be synced with the application daily.&#xD;
      For the intervention, study subjects will be asked to achieve a goal of 10,000 steps a day&#xD;
      and to engage in 30 minutes of continuous exercise every day and this can be any form of&#xD;
      exercise.&#xD;
&#xD;
      All patients who agree to participate will be invited to the Johns Hopkins Hospital medical&#xD;
      campus where all the testing will be performed. The investigators expect to complete the&#xD;
      study in 9 months.&#xD;
&#xD;
      Study participants who agree to participate will have the following assessments performed at&#xD;
      baseline:&#xD;
&#xD;
        1. A Cardiopulmonary Exercise Stress Test done using the standard protocol and supervised&#xD;
           by an exercise physiologist.&#xD;
&#xD;
        2. A 2D echocardiogram. The echocardiogram will include assessment of strain using speckle&#xD;
           tracking and tissue Doppler and the determination of systolic ejection time. All&#xD;
           patients routinely have an echocardiogram performed prior to the initiation of&#xD;
           cardio-toxic chemotherapy such as doxorubicin (Adriamycin), trastuzumab (Herceptin) and&#xD;
           pertuzumab (Perjeta), however, for the study, strain analysis will be performed off line&#xD;
           on the images obtained during the clinically indicated baseline echocardiogram.&#xD;
           Echocardiograms will be performed by experienced sonographers and on the same model echo&#xD;
           machine to reduce variability.&#xD;
&#xD;
        3. Bone densitometry assessment via a Dual-energy X-ray absorptiometry to measure total and&#xD;
           regional body composition in the frontal plane to determine bone, fat and fat-free mass.&#xD;
           The Dual-energy X-ray absorptiometry scan takes about 8-10 minutes. The total radiation&#xD;
           dose is approximately 1 millirem, which is very small.&#xD;
&#xD;
        4. Muscle strength will be measured using a hand grip tool.&#xD;
&#xD;
        5. Habitual activity levels will be assessed using the Rapid Assessment of Physical&#xD;
           Activity questionnaire, which categorizes activity levels on a scale from 1-7 (sedentary&#xD;
           to active).&#xD;
&#xD;
        6. Quality of life will be assessed with the Functional Assessment of Cancer Therapy-Breast&#xD;
           survey&#xD;
&#xD;
        7. Fatigue level will be performed with the Multidimensional Fatigue Symptom&#xD;
           Inventory-Short Form&#xD;
&#xD;
        8. All patients routinely have blood work collected, and as part of this research protocol,&#xD;
           the investigators will also collect blood to determine baseline tumor markers (&#xD;
           high-sensitivity C-reactive protein, Insulin-like growth factor 1, interleukin -6,&#xD;
           interleukin-1 and tumor necrosis factor alpha, leptin, adiponectin, estradiol, DNA&#xD;
           extraction, lymphocyte telomere length) and cardiac biomarkers (high sensitivity&#xD;
           troponin, troponin, pro-brain natriuretic peptide). The investigators will also collect&#xD;
           and store blood in order to keep open the possibility of doing a more extensive study to&#xD;
           look at any future genes that might be related to the phenotypes in this study (cancer,&#xD;
           cardiomyopathy, exercise response, etc.).&#xD;
&#xD;
        9. Cardiac history will be obtained at recruitment, including clinical risk factors for&#xD;
           heart disease (hypertension, diabetes and smoking history) and participants will be&#xD;
           evaluated throughout the study for any cardiac symptoms especially those of Heart&#xD;
           failure.&#xD;
&#xD;
      All of the above assessments will all be performed at baseline and repeated within 2 weeks of&#xD;
      the women completing their anthracycline-based chemotherapy. The investigators will also&#xD;
      track the clinical echocardiograms obtained at 12 months, but these results are not required&#xD;
      for the study.&#xD;
&#xD;
      Other studies: Serum troponin levels will be checked with each cycle of chemotherapy. Height&#xD;
      will be measured upon recruitment and weight and blood pressure will be measured at the time&#xD;
      of each echocardiogram.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">October 2019</completion_date>
  <primary_completion_date type="Actual">October 2019</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>Left ventricular dysfunction</measure>
    <time_frame>Change from baseline to up to 14 weeks</time_frame>
    <description>Development of left ventricular dysfunction, assessed by echocardiogram and defined as a decrease in global longitudinal strain between the baseline echocardiogram and the echocardiogram obtained post-treatment with an anthracycline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiorespiratory fitness/peak oxygen consumption</measure>
    <time_frame>Up to 14 weeks</time_frame>
    <description>Cardiorespiratory fitness/peak oxygen consumption measured using a metabolic stress test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dual-energy x-ray absorptiometry</measure>
    <time_frame>Up to 14 weeks</time_frame>
    <description>Dual-energy x-ray absorptiometry scan will be performed using standard procedures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life as assessed by the Functional Assessment of Cancer Therapy-Breast Survey</measure>
    <time_frame>Up to 14 weeks</time_frame>
    <description>Functional Assessment of Cancer Therapy-Breast survey will be administered upon completion of therapy to assess for change in quality of life. Each question on the questionnaire ranges from 0 to 4. The least score is 0 and the maximum is 148 points. Higher scores indicate a higher quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity as assessed by the Rapid Assessment of Physical Activity Questionnaire</measure>
    <time_frame>Up to 14 weeks</time_frame>
    <description>Change in physical activity with the intervention will be assessed by the Rapid Assessment of Physical Activity questionnaire. This is scored from 1 to 7 with 7 being the most active.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue as assessed by the Multidimensional Fatigue Symptom Inventory-Short Form</measure>
    <time_frame>Up to 14 weeks</time_frame>
    <description>Multidimensional Fatigue Symptom Inventory-Short Form will be used to assess for change in fatigue. Scores for each question range from 0 to 4. The maximum total fatigue score is 72. The higher the score, the more fatigued one is.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of motivational messages on increasing the amount of physical activity</measure>
    <time_frame>Up to 14 weeks</time_frame>
    <description>Analysis will be performed to assess the impact that receiving motivational text messages has on increasing the amount of physical activity performed/number of daily steps achieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of telephone calls on increasing the amount of physical activity</measure>
    <time_frame>Up to 14 weeks</time_frame>
    <description>Analysis will be performed to assess the impact of weekly telephone calls on increasing the amount of physical activity/number of daily steps achieved</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of engaging in 30 minutes of exercise on increasing the amount of physical activity</measure>
    <time_frame>Up to 14 weeks</time_frame>
    <description>Analysis will be performed to assess the impact that engaging in 30 minutes of daily exercise has on increasing the amount of physical activity performed/number of daily steps achieved</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Troponin</measure>
    <time_frame>Change from baseline to up to 14 weeks</time_frame>
    <description>Difference in troponin levels in the the two groups post treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Breast Cancer Female</condition>
  <condition>Adriamycin Toxicity</condition>
  <arm_group>
    <arm_group_label>10,000 steps</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For the &quot;10,000 steps&quot; group, participants will be asked to achieve a goal of 10,000 steps a day and to engage in 30 minutes of continuous exercise every day. Steps will be monitored with the under Armour fitness tracker which participants will receive.&#xD;
For motivation, messages will be sent to study participants in this group via the messaging center in the Under Armor application three times a week. The frequency of messaging will be increased for participants who fail to meet their goals for three consecutive days. Study participants will also receive a weekly call to assess for side effects and provide additional encouragement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This will be the usual care group. Participants will also receive a fitness tracker to enable monitoring of steps and will be given a flyer that references the ACC/AHA guidelines for exercise and physical activity for the general population. Participants will not receive text messages or phone calls.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>10,000 steps</intervention_name>
    <description>Participants will be asked to achieve 10,000 steps daily and to participate in 30 minutes of continuous exercise of their choosing. They will also receive text messages during the week and weekly motivational call</description>
    <arm_group_label>10,000 steps</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Participants will receive the ACC/AHA exercise guidelines</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who are 18 years and older&#xD;
&#xD;
          -  Women newly diagnosed with stage I to III breast cancer who will be receiving adjuvant&#xD;
             or neoadjuvant doxorubicin-based chemotherapy&#xD;
&#xD;
          -  Women who will be treated at the Johns Hopkins Hospital, Sibley Memorial Hospital or&#xD;
             who will be treated by oncologists in the community as long as we will have access to&#xD;
             treatment records.&#xD;
&#xD;
          -  Women must be willing to receive follow up care either at Hopkins or with their local&#xD;
             oncologist for at least 1 year.&#xD;
&#xD;
          -  Patients who are receiving therapy with an anthracycline.&#xD;
&#xD;
          -  Women who have a smart phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to exercise&#xD;
&#xD;
          -  Presence of metastatic disease&#xD;
&#xD;
          -  Advanced pulmonary disease as assessed by clinical symptoms of shortness of breath or&#xD;
             known forced expiratory volume in 1 second &lt; 1&#xD;
&#xD;
          -  Any patients requiring oxygen at baseline&#xD;
&#xD;
          -  The presence of known ischemic heart disease as defined by significant obstructive&#xD;
             heart disease (stenosis &gt; 70%) seen on coronary angiography or cardiac CT&#xD;
&#xD;
          -  Abnormal baseline cardiac function defined as an ejection fraction of less than 55%&#xD;
&#xD;
          -  The presence of more than mild valvular stenosis or regurgitation, prosthetic valves&#xD;
             or pacemaker on their baseline echocardiogram&#xD;
&#xD;
          -  Poor image quality on baseline echocardiogram or anatomic limitations that preclude&#xD;
             the acquisition of good quality images such as recent mastectomy or surgery&#xD;
&#xD;
          -  Patients who do not have a smart phone onto which the Under Armour application can be&#xD;
             downloaded&#xD;
&#xD;
          -  Patients who are unwilling to wear the Under Armour health band&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Previous anthracycline exposure&#xD;
&#xD;
          -  Rhythms other than sinus rhythm&#xD;
&#xD;
          -  Patients unwilling to come to the Johns Hopkins campus to have the required testing&#xD;
             performed&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roberta Florido, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>December 31, 2020</last_update_submitted>
  <last_update_submitted_qc>December 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Speckle tracking echocardiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03027063
org study id: IRB00110810
nct id: NCT03027063
lead sponsor: 
has dmc: No
This research is being done to determine whether exercise while receiving doxorubicin or
      Adriamycin chemotherapy for breast cancer can reduce the cardio-toxic effects of this
      treatment on the heart and improve other outcomes related to cancer such as tumor markers,
      nausea, fatigue and the ability to tolerate chemotherapy.
This will be a pilot study that looks at the effect of exercise, while receiving
      anthracycline therapy, on mitigating the cardio toxic effects of anthracyclines as assessed
      by serial echocardiographic strain analysis.

      Potential participants will be identified during chart review in advance of a routine clinic
      visit or during a routine clinic visit with a provider. Individuals will be approached by the
      provider or study team to determine willingness to learn more about a study for which they
      may be eligible. Discussions regarding study participation will take place privately and
      individuals will be provided with the Institutional Review Board (IRB) approved consent form.

      In addition, potential participants may contact the study team directly. This contact may be
      in the form of telephone, email, etc. Initial discussions regarding study participation may
      take place by phone, email, etc., and individuals may be provided with the IRB approved
      consent form and other IRB reviewed and approved materials (e.g., Patient Handout), as
      applicable.

      In all cases, as much time as is needed to consider study participation will be allowed to
      possible participants; resulting in multiple phone calls, visits, emails, or other
      communication, as necessary. For individuals who choose to take part, informed consent will
      happen as per the consent process.

      Patients will be recruited from the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center,
      Sibley Memorial Hospital and the community. The investigators anticipate that among roughly
      60 subjects approached for enrollment, 30 will be part of the final study. Participants who
      agree to participate will be asked to provide written consent. Participants will be
      randomized by an online system to one of the following two groups in a 1:2 ratio. Group
      1(Usual care group) will receive a fitness tracker and flyers that reference the American
      College of Cardiology/American Heart Association (ACC/AHA) guidelines for exercise and
      physical activity for the general population. In addition to fitness tracker and flyers,
      Group 2 (10,000 steps group) will receive additional messages and phone calls for motivation.
      This group of participants will also be asked to take part in 30 minutes of continuous
      exercise daily as part of their intervention.

      For motivation, messages will be sent to study participants in group 2 via the messaging
      center in the Under Armour application three times a week. With the application, study
      participant will receive a phone alert and an email message to which they may respond if
      needed. The frequency of messaging will be increased for participants who fail to meet their
      goals for three consecutive days. In addition to the Under Armour application, participants
      will be provided with a log sheet for recording their daily steps, whether 30 minutes of
      continuous activity daily was completed and the type of the activity done for the 30 minutes.
      Group two study subjects will also receive a weekly call to assess for side effects and
      provide additional encouragement. Log sheets will be collected during oncology clinic visits
      and the aforementioned intervention will be continued for the duration of their chemotherapy
      treatment. Group 1 study participants will be assessed for side effects through a phone call
      every 4 weeks.

      For the study, women will be given an Under Armour band that will monitor daily steps, amount
      of sleep and heart rate. Participants will be asked to download the Under Armour application
      to their mobile phones so the data from their bands can be synced with the application daily.
      For the intervention, study subjects will be asked to achieve a goal of 10,000 steps a day
      and to engage in 30 minutes of continuous exercise every day and this can be any form of
      exercise.

      All patients who agree to participate will be invited to the Johns Hopkins Hospital medical
      campus where all the testing will be performed. The investigators expect to complete the
      study in 9 months.

      Study participants who agree to participate will have the following assessments performed at
      baseline:

        1. A Cardiopulmonary Exercise Stress Test done using the standard protocol and supervised
           by an exercise physiologist.

        2. A 2D echocardiogram. The echocardiogram will include assessment of strain using speckle
           tracking and tissue Doppler and the determination of systolic ejection time. All
           patients routinely have an echocardiogram performed prior to the initiation of
           cardio-toxic chemotherapy such as doxorubicin (Adriamycin), trastuzumab (Herceptin) and
           pertuzumab (Perjeta), however, for the study, strain analysis will be performed off line
           on the images obtained during the clinically indicated baseline echocardiogram.
           Echocardiograms will be performed by experienced sonographers and on the same model echo
           machine to reduce variability.

        3. Bone densitometry assessment via a Dual-energy X-ray absorptiometry to measure total and
           regional body composition in the frontal plane to determine bone, fat and fat-free mass.
           The Dual-energy X-ray absorptiometry scan takes about 8-10 minutes. The total radiation
           dose is approximately 1 millirem, which is very small.

        4. Muscle strength will be measured using a hand grip tool.

        5. Habitual activity levels will be assessed using the Rapid Assessment of Physical
           Activity questionnaire, which categorizes activity levels on a scale from 1-7 (sedentary
           to active).

        6. Quality of life will be assessed with the Functional Assessment of Cancer Therapy-Breast
           survey

        7. Fatigue level will be performed with the Multidimensional Fatigue Symptom
           Inventory-Short Form

        8. All patients routinely have blood work collected, and as part of this research protocol,
           the investigators will also collect blood to determine baseline tumor markers (
           high-sensitivity C-reactive protein, Insulin-like growth factor 1, interleukin -6,
           interleukin-1 and tumor necrosis factor alpha, leptin, adiponectin, estradiol, DNA
           extraction, lymphocyte telomere length) and cardiac biomarkers (high sensitivity
           troponin, troponin, pro-brain natriuretic peptide). The investigators will also collect
           and store blood in order to keep open the possibility of doing a more extensive study to
           look at any future genes that might be related to the phenotypes in this study (cancer,
           cardiomyopathy, exercise response, etc.).

        9. Cardiac history will be obtained at recruitment, including clinical risk factors for
           heart disease (hypertension, diabetes and smoking history) and participants will be
           evaluated throughout the study for any cardiac symptoms especially those of Heart
           failure.

      All of the above assessments will all be performed at baseline and repeated within 2 weeks of
      the women completing their anthracycline-based chemotherapy. The investigators will also
      track the clinical echocardiograms obtained at 12 months, but these results are not required
      for the study.

      Other studies: Serum troponin levels will be checked with each cycle of chemotherapy. Height
      will be measured upon recruitment and weight and blood pressure will be measured at the time
      of each echocardiogram.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Left ventricular dysfunction
time frame: Change from baseline to up to 14 weeks
description: Development of left ventricular dysfunction, assessed by echocardiogram and defined as a decrease in global longitudinal strain between the baseline echocardiogram and the echocardiogram obtained post-treatment with an anthracycline.
measure: Cardiorespiratory fitness/peak oxygen consumption
time frame: Up to 14 weeks
description: Cardiorespiratory fitness/peak oxygen consumption measured using a metabolic stress test
measure: Dual-energy x-ray absorptiometry
time frame: Up to 14 weeks
description: Dual-energy x-ray absorptiometry scan will be performed using standard procedures
measure: Quality of life as assessed by the Functional Assessment of Cancer Therapy-Breast Survey
time frame: Up to 14 weeks
description: Functional Assessment of Cancer Therapy-Breast survey will be administered upon completion of therapy to assess for change in quality of life. Each question on the questionnaire ranges from 0 to 4. The least score is 0 and the maximum is 148 points. Higher scores indicate a higher quality of life.
measure: Physical Activity as assessed by the Rapid Assessment of Physical Activity Questionnaire
time frame: Up to 14 weeks
description: Change in physical activity with the intervention will be assessed by the Rapid Assessment of Physical Activity questionnaire. This is scored from 1 to 7 with 7 being the most active.
measure: Fatigue as assessed by the Multidimensional Fatigue Symptom Inventory-Short Form
time frame: Up to 14 weeks
description: Multidimensional Fatigue Symptom Inventory-Short Form will be used to assess for change in fatigue. Scores for each question range from 0 to 4. The maximum total fatigue score is 72. The higher the score, the more fatigued one is.
measure: Impact of motivational messages on increasing the amount of physical activity
time frame: Up to 14 weeks
description: Analysis will be performed to assess the impact that receiving motivational text messages has on increasing the amount of physical activity performed/number of daily steps achieved.
measure: Impact of telephone calls on increasing the amount of physical activity
time frame: Up to 14 weeks
description: Analysis will be performed to assess the impact of weekly telephone calls on increasing the amount of physical activity/number of daily steps achieved
measure: Impact of engaging in 30 minutes of exercise on increasing the amount of physical activity
time frame: Up to 14 weeks
description: Analysis will be performed to assess the impact that engaging in 30 minutes of daily exercise has on increasing the amount of physical activity performed/number of daily steps achieved
measure: Serum Troponin
time frame: Change from baseline to up to 14 weeks
description: Difference in troponin levels in the the two groups post treatment
arm group label: 10,000 steps
arm group type: Experimental
description: For the "10,000 steps" group, participants will be asked to achieve a goal of 10,000 steps a day and to engage in 30 minutes of continuous exercise every day. Steps will be monitored with the under Armour fitness tracker which participants will receive.
For motivation, messages will be sent to study participants in this group via the messaging center in the Under Armor application three times a week. The frequency of messaging will be increased for participants who fail to meet their goals for three consecutive days. Study participants will also receive a weekly call to assess for side effects and provide additional encouragement.
arm group label: Usual care
arm group type: Active Comparator
description: This will be the usual care group. Participants will also receive a fitness tracker to enable monitoring of steps and will be given a flyer that references the ACC/AHA guidelines for exercise and physical activity for the general population. Participants will not receive text messages or phone calls.
intervention type: Behavioral
intervention name: 10,000 steps
description: Participants will be asked to achieve 10,000 steps daily and to participate in 30 minutes of continuous exercise of their choosing. They will also receive text messages during the week and weekly motivational call
arm group label: 10,000 steps
intervention type: Behavioral
intervention name: Usual Care
description: Participants will receive the ACC/AHA exercise guidelines
arm group label: Usual care
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roberta Florido, MD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No