<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/NCT03000166</url>
  </required_header>
  <id_info>
    <org_study_id>P20NR015339-PP3</org_study_id>
    <secondary_id>P20NR015339</secondary_id>
    <nct_id>NCT03000166</nct_id>
  </id_info>
  <brief_title>Step-Up Intervention for Self-Management of Fatigue in Young Adults Receiving Chemotherapy</brief_title>
  <official_title>Step-Up Intervention for Self-Management of Fatigue in Young Adults Receiving Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Milwaukee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Froedtert Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital and Health System Foundation, Wisconsin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Milwaukee</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of the study is to determine the impact of a physical activity intervention on&#xD;
      the self-management of fatigue in young adults receiving chemotherapy. Half of the&#xD;
      participants will receive an intervention which includes education and resources to set&#xD;
      physical activity goals and monitor progress toward goals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interventions to increase physical activity have been shown to relieve fatigue in patients&#xD;
      receiving chemotherapy, but no studies have tested a physical activity intervention to&#xD;
      improve fatigue in young adults receiving chemotherapy. This study will determine the impact&#xD;
      of a physical activity intervention on the self-management process variables of self-efficacy&#xD;
      and self-regulation and their relationships to physical activity and fatigue severity in&#xD;
      young adults receiving chemotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2017</start_date>
  <completion_date type="Actual">July 16, 2019</completion_date>
  <primary_completion_date type="Actual">May 1, 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-efficacy for Physical Activity</measure>
    <time_frame>Completion of post-study measures (average 15 weeks)</time_frame>
    <description>Physical Activity Assessment Inventory (Haas &amp; Northam, 2010) The scale measures confidence to be physically active under various conditions. Scores range from 0=cannot do at all to 100=certain can do.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-regulation of Physical Activity</measure>
    <time_frame>Completion of post-study measures (average 15 weeks)</time_frame>
    <description>Index of Self-Regulation (Yeom et al., 2011) The scale measures self-regulation skills, including processing information, monitoring performance, and taking action to meet goals. Scores range from 1 to 6, with higher scores indicating agreement that the individual has these skills.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Steps Per Day</measure>
    <time_frame>Completion of post-study measures (average 15 weeks)</time_frame>
    <description>Measured by accelerometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue Severity</measure>
    <time_frame>Completion of end-of-study measures (average 15 weeks)</time_frame>
    <description>Measured with PROMIS - Fatigue Short Form Fatigue severity is measured over the past 7 days from 1=never to 5=always. The raw scores are converted to T-scores, where 50=average fatigue in the general population. Higher scores indicate greater fatigue severity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Young Adult, Cancer, Physical Activity</condition>
  <arm_group>
    <arm_group_label>Step-Up Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to the Step-up intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Step-Up Intervention</intervention_name>
    <description>Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker.</description>
    <arm_group_label>Step-Up Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  have a diagnosis of cancer;&#xD;
&#xD;
          -  are within the first two months of a chemotherapy regimen that will last at least&#xD;
             another 3 months;&#xD;
&#xD;
          -  are ambulatory without assistance;&#xD;
&#xD;
          -  have written consent from their physician to participate;&#xD;
&#xD;
          -  have the ability to understand English;&#xD;
&#xD;
          -  have access to a computer and the Internet.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  symptoms of uncontrolled cardiopulmonary disease, neurological disease&#xD;
&#xD;
          -  delayed wound healing&#xD;
&#xD;
          -  high risk of bone fracture&#xD;
&#xD;
          -  pre-existing peripheral neuropathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel Schiffman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Milwaukee</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Froedtert Hospital</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <results_first_submitted>September 30, 2020</results_first_submitted>
  <results_first_submitted_qc>July 19, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 11, 2021</results_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Wisconsin, Milwaukee</investigator_affiliation>
    <investigator_full_name>Jeanne M. Erickson</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03000166/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Of 471 screened participants, 67 met inclusion criteria and were invited to participate in the study. 47 agreed to participate. 25 were randomized to the Step-Up intervention group, and 22 were randomized to the attention control group.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Step-up Intervention Group</title>
          <description>Participants assigned to the intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity.&#xD;
Step-Up Intervention: Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker.</description>
        </group>
        <group group_id="P2">
          <title>Attention Control Group</title>
          <description>Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Step-Up Intervention Group</title>
          <description>Participants assigned to the Step-Up intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity.&#xD;
Step-Up Intervention: Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker.</description>
        </group>
        <group group_id="B2">
          <title>Attention Control Group</title>
          <description>Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="47"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.96" spread="4.71"/>
                    <measurement group_id="B2" value="32.77" spread="5.79"/>
                    <measurement group_id="B3" value="32.3" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fatigue</title>
          <description>PROMIS Fatigue Short form. Participants self-report their fatigue over the past 7 days using the 8-item PROMIS Fatigue Short Form. The response scale is a 5-point Likert scale (1-never to 5-always). Raw scores can range from 8-40. Raw scores are converted to standardized T-scores, with higher scores indicating greater fatigue severity. T-Scores range from 33.1 - 77.8. A T-score of 50 represents the average fatigue severity of a national sample of the general US population. A score over 50 represents a person with more than average fatigue while a score under 50 is less than average fatigue.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.2" spread="10.6"/>
                    <measurement group_id="B2" value="56.6" spread="7.8"/>
                    <measurement group_id="B3" value="55.3" spread="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Light Intensity Physical Activity</title>
          <description>As measured with a waist-worn accelerometer. The accelerometer counts the number of times a person moves forward in a certain time period (counts per minute). Accelerometer data was analyzed using the ActiLife software (v13.3). Freedson adult cutpoints in counts per minute (cpm) were applied to assess time spent in sedentary (0-99 cpm), light (100-2019 cpm), moderate (2020-5998 cpm), and vigorous (&gt;5999 cpm) physical activity. The intensity of physical activity corresponds to the energy expended by that individual. Light intensity physical activity requires the least amount of effort.</description>
          <units>minutes/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="228.7" spread="61.3"/>
                    <measurement group_id="B2" value="208.7" spread="60.1"/>
                    <measurement group_id="B3" value="220.27" spread="60.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Moderate intensity physical activity</title>
          <description>As measured by waist-worn accelerometer. The accelerometer counts the number of times a person moves forward in a time points. Accelerometer data was analyzed using the ActiLife software. Freedson adult cutpoints in counts per minute (cpm) were applied to assess time spent in sedentary (0-99 cpm), light (100-2019 cpm), moderate (2020-5998 cpm), and vigorous (&gt;5999 cpm) physical activity. The intensity of physical activity corresponds to the energy expended by that individual. Moderate intensity physical activity requires medium effort, such as walking fast.</description>
          <units>minutes/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.2" spread="19.9"/>
                    <measurement group_id="B2" value="15.3" spread="20.0"/>
                    <measurement group_id="B3" value="14.1" spread="19.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Steps/day</title>
          <description>As measured by a waist-worn accelerometer. Steps per day were calculated using algorithms that were based on records of accelerations (forward movements) that occur during ambulation (walking). Around 10,000 steps/day is a reasonable number of steps recommended as activity for healthy adults.</description>
          <units>steps/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4227.4" spread="2429"/>
                    <measurement group_id="B2" value="4288.8" spread="2545"/>
                    <measurement group_id="B3" value="4253.2" spread="2444"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self-efficacy for Physical Activity</title>
          <description>As measured by the Physical Activity Assessment Inventory (PAAI).The PAAI is a 13-item scale and was developed to measure confidence to be physically active under various conditions. Responses are measured on a 100-point scale, ranging from 0 (&quot;cannot do at all&quot;) to 100 (&quot;certain can do&quot;). An average score is calculated, and a higher score indicates greater self-efficacy. Higher scores that mean more confidence in the ability to be physically active in various conditions would be a positive outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.7" spread="23.4"/>
                    <measurement group_id="B2" value="59.4" spread="24.4"/>
                    <measurement group_id="B3" value="61.2" spread="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self-regulation for Physical Activity</title>
          <description>As measured by the Index of Self-Regulation (ISR).The ISR is a 9-item scale that measures levels of self-regulation, which includes ability to process information, monitor performance, and take action in relation to goals. Responses are measured on a 6-point Likert scale (1=strongly disagree to 6=strongly agree), and scores can range from 9-54. An average score is calculated, and a higher score indicates a higher level of self-regulation. Higher scores indicating a higher level of self-regulation is a positive outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.24" spread="1.10"/>
                    <measurement group_id="B2" value="4.10" spread="0.99"/>
                    <measurement group_id="B3" value="4.18" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Self-efficacy for Physical Activity</title>
        <description>Physical Activity Assessment Inventory (Haas &amp; Northam, 2010) The scale measures confidence to be physically active under various conditions. Scores range from 0=cannot do at all to 100=certain can do.</description>
        <time_frame>Completion of post-study measures (average 15 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Step-Up Intervention Group</title>
            <description>Participants assigned to the Step-up intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity.&#xD;
Step-Up Intervention: Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker.</description>
          </group>
          <group group_id="O2">
            <title>Attention Control Group</title>
            <description>Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-efficacy for Physical Activity</title>
          <description>Physical Activity Assessment Inventory (Haas &amp; Northam, 2010) The scale measures confidence to be physically active under various conditions. Scores range from 0=cannot do at all to 100=certain can do.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.6" spread="22.9"/>
                    <measurement group_id="O2" value="56.2" spread="24.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.22</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Self-regulation of Physical Activity</title>
        <description>Index of Self-Regulation (Yeom et al., 2011) The scale measures self-regulation skills, including processing information, monitoring performance, and taking action to meet goals. Scores range from 1 to 6, with higher scores indicating agreement that the individual has these skills.</description>
        <time_frame>Completion of post-study measures (average 15 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Step-Up Intervention Group</title>
            <description>Participants assigned to the Step-up intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity.&#xD;
Step-Up Intervention: Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker.</description>
          </group>
          <group group_id="O2">
            <title>Attention Control Group</title>
            <description>Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-regulation of Physical Activity</title>
          <description>Index of Self-Regulation (Yeom et al., 2011) The scale measures self-regulation skills, including processing information, monitoring performance, and taking action to meet goals. Scores range from 1 to 6, with higher scores indicating agreement that the individual has these skills.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" spread="0.8"/>
                    <measurement group_id="O2" value="4.4" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.40</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Steps Per Day</title>
        <description>Measured by accelerometer</description>
        <time_frame>Completion of post-study measures (average 15 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Step-up Intervention Group</title>
            <description>Participants assigned to the Step-up intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity.&#xD;
Step-Up Intervention: Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker.</description>
          </group>
          <group group_id="O2">
            <title>Attention Control Group</title>
            <description>Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.</description>
          </group>
        </group_list>
        <measure>
          <title>Steps Per Day</title>
          <description>Measured by accelerometer</description>
          <units>steps per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4720" spread="3772"/>
                    <measurement group_id="O2" value="3991" spread="2428"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.17</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fatigue Severity</title>
        <description>Measured with PROMIS - Fatigue Short Form Fatigue severity is measured over the past 7 days from 1=never to 5=always. The raw scores are converted to T-scores, where 50=average fatigue in the general population. Higher scores indicate greater fatigue severity.</description>
        <time_frame>Completion of end-of-study measures (average 15 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Step-up Intervention Group</title>
            <description>Participants assigned to the Step-up intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity.&#xD;
Step-Up Intervention: Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker.</description>
          </group>
          <group group_id="O2">
            <title>Attention Control Group</title>
            <description>Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.</description>
          </group>
        </group_list>
        <measure>
          <title>Fatigue Severity</title>
          <description>Measured with PROMIS - Fatigue Short Form Fatigue severity is measured over the past 7 days from 1=never to 5=always. The raw scores are converted to T-scores, where 50=average fatigue in the general population. Higher scores indicate greater fatigue severity.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.6" spread="7.2"/>
                    <measurement group_id="O2" value="57.4" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.20</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data related to adverse events were collected over the duration of the time each participant was on study. Participants were considered on study from the date of enrollment through the completion of completion of post-study data collection. The average time for each participant to be on study was 15 weeks, but ranged from 10-23 weeks due to variations in the timing of their chemotherapy as well as completion of post-study measures.</time_frame>
      <desc>Adverse events were defined as serious or not serious.</desc>
      <group_list>
        <group group_id="E1">
          <title>Step-up Intervention Group</title>
          <description>Participants assigned to the Step-up intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity.&#xD;
Step-Up Intervention: Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker.</description>
        </group>
        <group group_id="E2">
          <title>Attention Control Group</title>
          <description>Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jeanne M. Erickson, PhD, RN</name_or_title>
      <organization>University of Wisconsin-Milwaukee</organization>
      <phone>414-229-6920</phone>
      <email>ericksoj@uwm.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03000166
org study id: P20NR015339-PP3
secondary id: P20NR015339
nct id: NCT03000166
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to determine the impact of a physical activity intervention on
      the self-management of fatigue in young adults receiving chemotherapy. Half of the
      participants will receive an intervention which includes education and resources to set
      physical activity goals and monitor progress toward goals.
Interventions to increase physical activity have been shown to relieve fatigue in patients
      receiving chemotherapy, but no studies have tested a physical activity intervention to
      improve fatigue in young adults receiving chemotherapy. This study will determine the impact
      of a physical activity intervention on the self-management process variables of self-efficacy
      and self-regulation and their relationships to physical activity and fatigue severity in
      young adults receiving chemotherapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Self-efficacy for Physical Activity
time frame: Completion of post-study measures (average 15 weeks)
description: Physical Activity Assessment Inventory (Haas & Northam, 2010) The scale measures confidence to be physically active under various conditions. Scores range from 0=cannot do at all to 100=certain can do.
measure: Self-regulation of Physical Activity
time frame: Completion of post-study measures (average 15 weeks)
description: Index of Self-Regulation (Yeom et al., 2011) The scale measures self-regulation skills, including processing information, monitoring performance, and taking action to meet goals. Scores range from 1 to 6, with higher scores indicating agreement that the individual has these skills.
measure: Steps Per Day
time frame: Completion of post-study measures (average 15 weeks)
description: Measured by accelerometer
measure: Fatigue Severity
time frame: Completion of end-of-study measures (average 15 weeks)
description: Measured with PROMIS - Fatigue Short Form Fatigue severity is measured over the past 7 days from 1=never to 5=always. The raw scores are converted to T-scores, where 50=average fatigue in the general population. Higher scores indicate greater fatigue severity.
arm group label: Step-Up Intervention Group
arm group type: Experimental
description: Participants assigned to the Step-up intervention group will receive a 12-week physical activity intervention which includes components of education, negotiated collaboration to set individual physical activity goals during chemotherapy cycles, and tools for self-monitoring of physical activity.
arm group label: Attention Control Group
arm group type: No Intervention
description: Participants assigned to the attention control group will receive usual guidance about maintaining physical activity during chemotherapy from their oncology providers.
intervention type: Behavioral
intervention name: Step-Up Intervention
description: Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker.
arm group label: Step-Up Intervention Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 39 Years
healthy volunteers: No
last name: Rachel Schiffman, PhD
role: Principal Investigator
affiliation: University of Wisconsin, Milwaukee
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Wisconsin, Milwaukee
investigator full name: Jeanne M. Erickson
investigator title: Assistant Professor
mesh term: Fatigue
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 