<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/NCT02191982</url>
  </required_header>
  <id_info>
    <org_study_id>LCCC1402</org_study_id>
    <nct_id>NCT02191982</nct_id>
  </id_info>
  <brief_title>The Effect of Walking on Fatigue After Chemotherapy in Patients 65 and Older</brief_title>
  <acronym>S-PACT</acronym>
  <official_title>A Randomized, Wait-list Controlled Clinical Trial: the Effect of a Physical Activity Program on Fatigue After Potentially Curative Chemotherapy Among Cancer Survivors Age 65 or Older -- PACT (Physical Activity After Chemotherapy)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNC Lineberger Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Breast Cancer Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>UNC Lineberger Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will look at the impact of a self-directed walking program on post-chemotherapy&#xD;
      survivors experiencing fatigue. It is hypothesized that the walking program will help lessen&#xD;
      fatigue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investiagors propose to evaluate the impact of a home-based self-directed walking program&#xD;
      on post-chemotherapy fatigue among 150 cancer survivors age 65 and older -- Senior Physical&#xD;
      Activity after Chemotherapy (S-PACT). Participants must have potentially curable cancer,&#xD;
      moderate to severe fatigue (score of 4 or higher on the Brief Fatigue Inventory), currently&#xD;
      exercise less than 120 minutes per week and have completed chemotherapy treatment (radiation&#xD;
      treatment must also be completed if it is part of the patient's treatment plan) within the&#xD;
      last 6 weeks. The design is a randomized controlled trial, with participants randomized to a&#xD;
      3-month physical activity program (intervention group) or to wait-list control (this group&#xD;
      begins the walking program at 3 months post-randomization). The primary objective is to&#xD;
      compare the change in fatigue scores from baseline to 3 months between the intervention and&#xD;
      wait-list control groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To measure change in fatigue scores between intervention and wait list control arms from baseline to three months.</measure>
    <time_frame>Three months</time_frame>
    <description>Change in fatigue will be measured using the FACIT-F.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To measure change in fatigue scores between intervention and WLC arms from baseline to 3 months</measure>
    <time_frame>Three months</time_frame>
    <description>This outcome will be measured by the Brief Fatigue Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To report recruitment and retention in the study at 3 months</measure>
    <time_frame>Three months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To report recruitment and retention in the study at 6 months</measure>
    <time_frame>Six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To measure implementation of and adherence to WWE</measure>
    <time_frame>Six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To count the number of adverse events</measure>
    <time_frame>Six months</time_frame>
    <description>To characterize the safety of the walking program through a review of the number and type of adverse events, including falls, reported by study participants to the Study Team.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To measure change in engagement of walking over time from baseline to three months.</measure>
    <time_frame>Three Months</time_frame>
    <description>To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.&#xD;
Engagement in walking (total minutes per week) as measured by engagement in physical activity questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To measure change in physical function over time from baseline to three months.</measure>
    <time_frame>Three Months</time_frame>
    <description>To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.&#xD;
Physical function as measured by SPPB</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To measure change in quality of life over time from baseline to three months.</measure>
    <time_frame>Three Months</time_frame>
    <description>To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.&#xD;
Quality of life as measured by FACT-G (global and subscales) and symptom scales, including PROMIS pain intensity, sleep disturbance and depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To measure change in self-efficacy over time from baseline to three months.</measure>
    <time_frame>Three Months</time_frame>
    <description>To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.&#xD;
Engagement in walking (total minutes per week) as measured by engagement in physical activity questions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Cancer</condition>
  <condition>Geriatric</condition>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will begin the Walk With Ease program after the completion of chemotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait List Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The arm will begin the Walk With Ease program three months after completion of chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Walk With Ease</intervention_name>
    <description>Walk With Ease is the Arthritis Foundation's evidence-based walking intervention to help with fatigue and pain. The intervention is a self-directed program that helps guide participants in a safe and comfortable paced walking program with an ultimate goal of walking for 30 minutes a day, five days a week.</description>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_label>Wait List Control</arm_group_label>
    <other_name>WWE</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women age 65 years and older&#xD;
&#xD;
          -  Histologically or cytologically confirmed cancer (hematologic or solid) at stage&#xD;
             considered amenable to cure as assessed by the treating MD&#xD;
&#xD;
          -  Within 6 weeks of end of chemotherapy (all participants must have had chemotherapy&#xD;
             treatment)&#xD;
&#xD;
               -  Any radiation received must also be completed prior to randomization (if&#xD;
                  radiation treatment follows adjuvant chemotherapy, then the patient must be&#xD;
                  recruited within 6 weeks of end of radiation)&#xD;
&#xD;
               -  Maintenance hormonal therapy in women with breast cancer is allowed; see&#xD;
                  exclusion criteria regarding hormonal therapy in males with prostate cancer&#xD;
&#xD;
          -  Moderate to severe fatigue (&gt;4 on BFI)&#xD;
&#xD;
          -  Less than 120 minutes/week of physical activity&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Signed IRB approved written informed consent&#xD;
&#xD;
          -  Approval from their treating physician to engage in moderate-intensity physical&#xD;
             activity&#xD;
&#xD;
          -  Patient-assessed ability to walk and engage in moderate physical activity&#xD;
&#xD;
          -  Willing and able to meet all study requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receiving hormonal therapy for prostate cancer&#xD;
&#xD;
          -  Unable to walk or engage in moderate-intensity physical activity&#xD;
&#xD;
          -  Have BFI≤3.&#xD;
&#xD;
          -  Report more than 120 minutes/week of physical activity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyman B Muss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNC Lineberger Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina</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>
  <link>
    <url>https://unclineberger.org/patientcare/programs/geriatric</url>
    <description>UNC Geriatric Oncology Program</description>
  </link>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>June 20, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Elderly</keyword>
  <keyword>Geriatric</keyword>
  <keyword>Any Cancer</keyword>
  <keyword>Cancer Treatment</keyword>
  <keyword>Weakness</keyword>
  <keyword>Tiredness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</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/NCT02191982
org study id: LCCC1402
nct id: NCT02191982
lead sponsor: 
collaborator: 
has dmc: Yes
This study will look at the impact of a self-directed walking program on post-chemotherapy
      survivors experiencing fatigue. It is hypothesized that the walking program will help lessen
      fatigue.
The investiagors propose to evaluate the impact of a home-based self-directed walking program
      on post-chemotherapy fatigue among 150 cancer survivors age 65 and older -- Senior Physical
      Activity after Chemotherapy (S-PACT). Participants must have potentially curable cancer,
      moderate to severe fatigue (score of 4 or higher on the Brief Fatigue Inventory), currently
      exercise less than 120 minutes per week and have completed chemotherapy treatment (radiation
      treatment must also be completed if it is part of the patient's treatment plan) within the
      last 6 weeks. The design is a randomized controlled trial, with participants randomized to a
      3-month physical activity program (intervention group) or to wait-list control (this group
      begins the walking program at 3 months post-randomization). The primary objective is to
      compare the change in fatigue scores from baseline to 3 months between the intervention and
      wait-list control groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To measure change in fatigue scores between intervention and wait list control arms from baseline to three months.
time frame: Three months
description: Change in fatigue will be measured using the FACIT-F.
measure: To measure change in fatigue scores between intervention and WLC arms from baseline to 3 months
time frame: Three months
description: This outcome will be measured by the Brief Fatigue Inventory
measure: To report recruitment and retention in the study at 3 months
time frame: Three months
measure: To report recruitment and retention in the study at 6 months
time frame: Six months
measure: To measure implementation of and adherence to WWE
time frame: Six months
measure: To count the number of adverse events
time frame: Six months
description: To characterize the safety of the walking program through a review of the number and type of adverse events, including falls, reported by study participants to the Study Team.
measure: To measure change in engagement of walking over time from baseline to three months.
time frame: Three Months
description: To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.
Engagement in walking (total minutes per week) as measured by engagement in physical activity questions
measure: To measure change in physical function over time from baseline to three months.
time frame: Three Months
description: To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.
Physical function as measured by SPPB
measure: To measure change in quality of life over time from baseline to three months.
time frame: Three Months
description: To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.
Quality of life as measured by FACT-G (global and subscales) and symptom scales, including PROMIS pain intensity, sleep disturbance and depression.
measure: To measure change in self-efficacy over time from baseline to three months.
time frame: Three Months
description: To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.
Engagement in walking (total minutes per week) as measured by engagement in physical activity questions
arm group label: Intervention
arm group type: Experimental
description: This arm will begin the Walk With Ease program after the completion of chemotherapy.
arm group label: Wait List Control
arm group type: Active Comparator
description: The arm will begin the Walk With Ease program three months after completion of chemotherapy.
intervention type: Behavioral
intervention name: Walk With Ease
description: Walk With Ease is the Arthritis Foundation's evidence-based walking intervention to help with fatigue and pain. The intervention is a self-directed program that helps guide participants in a safe and comfortable paced walking program with an ultimate goal of walking for 30 minutes a day, five days a week.
arm group label: Intervention
arm group label: Wait List Control
other name: WWE
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Hyman B Muss, MD
role: Principal Investigator
affiliation: UNC Lineberger Comprehensive Cancer Center
facility: 
country: United States
url: https://unclineberger.org/patientcare/programs/geriatric
description: UNC Geriatric Oncology Program
responsible party type: Sponsor
mesh term: Fatigue