<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/NCT03751449</url>
  </required_header>
  <id_info>
    <org_study_id>i 67518</org_study_id>
    <secondary_id>NCI-2018-01704</secondary_id>
    <secondary_id>i 67518</secondary_id>
    <nct_id>NCT03751449</nct_id>
  </id_info>
  <brief_title>Exercise and Nutrition Education in Improving Physical Function and Quality of Life in Older Breast Cancer Survivors</brief_title>
  <official_title>Exercise and Nutrition Intervention in Older Breast Cancer Survivors - The WIN CA Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Roswell Park Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Roswell Park Cancer Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial studies how well exercise and nutrition education work in improving physical&#xD;
      function and quality of life in older breast cancer survivors. Exercise and nutrition&#xD;
      education may help to improve the level of fitness, cardiovascular health, and quality of&#xD;
      life in breast cancer survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the effect of a home-based aerobic and resistance exercise and nutrition&#xD;
      education intervention in overweight or obese, sedentary, older (65 years and above) breast&#xD;
      cancer survivors on physical function (6-minute walk test) and quality of life compared to&#xD;
      standard of care.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the effect of a home-based aerobic and resistance exercise and nutrition&#xD;
      education intervention on diet quality, sleep, anxiety, depression, source of motivation for&#xD;
      exercise, and immune function in overweight or obese, sedentary, older (65 years and above)&#xD;
      breast cancer survivors compared to standard of care.&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. To determine how body composition (dual X-ray absorptiometry [DEXA]) and weight&#xD;
      maintenance are affected by a 12-week aerobic and resistance exercise training program among&#xD;
      older (65 years and above), sedentary, overweight and obese breast cancer survivors.&#xD;
&#xD;
      II. To compare differences in the above outcomes among older (65 years and above), sedentary,&#xD;
      overweight and obese breast cancer survivors who completed a home-based aerobic and&#xD;
      resistance exercise training program versus those who did not receive the intervention,&#xD;
      standard of care.&#xD;
&#xD;
      OUTLINE: Participants are randomized to 1 of 2 groups.&#xD;
&#xD;
      GROUP I (ACTIVE TREATMENT): Participants complete a home-based aerobic and resistance&#xD;
      exercise program and receive nutrition education for 12 weeks.&#xD;
&#xD;
      GROUP II (WAITLIST): Participants are placed on a waitlist for 12 weeks and then complete a&#xD;
      home-based aerobic and resistance exercise program and receive nutrition education for 12&#xD;
      weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    lack of resources&#xD;
  </why_stopped>
  <start_date type="Actual">March 25, 2019</start_date>
  <completion_date type="Actual">May 21, 2021</completion_date>
  <primary_completion_date type="Actual">May 1, 2021</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>Activity levels for all participants will be collected using the Fitbit applications and a weekly activity log.</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Will measure the effect on physical function (6-minute walk test). Activity levels for all participants will be collected using the Fitbit applications and/or a weekly activity log.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life as assessed by the Self Geriatric Assessment Measure (GA-Self Assessment)</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Will measure the effect of a home-based aerobic and resistance exercise and nutrition education intervention on quality of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diet quality as assessed by the ASA24 website</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Will measure the effect of a home-based aerobic and resistance exercise and nutrition education intervention on diet quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>The PSQI measures the quality and pattern of sleeps in adults. There are 19 items. Each item is weighted on a 0-3 interval scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and the effect of a home-based aerobic and resistance exercise and nutrition education intervention</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Will measure anxiety as assessed by the State Trait Anxiety Inventory (STAI-Y1)e STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>motivation for exercise as assessed by the Behavioral Regulation for Exercise Questionnaire (BREQ-2)</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>A 19 item questionnaire that measures the stages of the self-determination continuum with respect to motivation to exercise with a 5 point Likert scale (0=not true for me, 4=very true for me)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Centers for Epidemiologic Studies Depression Scale (CESD-R)</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>A self reported 20 item scale that measures depressive symptoms. A higher score denotes greater depressive symptoms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Anatomic Stage I Breast Cancer AJCC v8</condition>
  <condition>Anatomic Stage IA Breast Cancer AJCC v8</condition>
  <condition>Anatomic Stage IB Breast Cancer AJCC v8</condition>
  <condition>Anatomic Stage II Breast Cancer AJCC v8</condition>
  <condition>Anatomic Stage IIA Breast Cancer AJCC v8</condition>
  <condition>Anatomic Stage IIB Breast Cancer AJCC v8</condition>
  <condition>Anatomic Stage III Breast Cancer AJCC v8</condition>
  <condition>Anatomic Stage IIIA Breast Cancer AJCC v8</condition>
  <condition>Anatomic Stage IIIB Breast Cancer AJCC v8</condition>
  <condition>Anatomic Stage IIIC Breast Cancer AJCC v8</condition>
  <condition>Cancer Survivor</condition>
  <condition>Inactivity</condition>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <condition>Prognostic Stage I Breast Cancer AJCC v8</condition>
  <condition>Prognostic Stage IA Breast Cancer AJCC v8</condition>
  <condition>Prognostic Stage IB Breast Cancer AJCC v8</condition>
  <condition>Prognostic Stage II Breast Cancer AJCC v8</condition>
  <condition>Prognostic Stage IIA Breast Cancer AJCC v8</condition>
  <condition>Prognostic Stage IIB Breast Cancer AJCC v8</condition>
  <condition>Prognostic Stage III Breast Cancer AJCC v8</condition>
  <condition>Prognostic Stage IIIA Breast Cancer AJCC v8</condition>
  <condition>Prognostic Stage IIIB Breast Cancer AJCC v8</condition>
  <condition>Prognostic Stage IIIC Breast Cancer AJCC v8</condition>
  <arm_group>
    <arm_group_label>Group I (active treatment)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants complete a home-based aerobic and resistance exercise program and receive nutrition education for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (waitlist)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants are placed on a waitlist for 12 weeks and then complete a home-based aerobic and resistance exercise program and receive nutrition education for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational Intervention</intervention_name>
    <description>Receive nutrition education</description>
    <arm_group_label>Group I (active treatment)</arm_group_label>
    <arm_group_label>Group II (waitlist)</arm_group_label>
    <other_name>Education for Intervention</other_name>
    <other_name>Intervention by Education</other_name>
    <other_name>Intervention through Education</other_name>
    <other_name>Intervention, Educational</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Intervention</intervention_name>
    <description>Complete home-based aerobic and resistance exercise program</description>
    <arm_group_label>Group I (active treatment)</arm_group_label>
    <arm_group_label>Group II (waitlist)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I (active treatment)</arm_group_label>
    <arm_group_label>Group II (waitlist)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I (active treatment)</arm_group_label>
    <arm_group_label>Group II (waitlist)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women with a history of breast cancer who have completed treatment &gt;=3 months&#xD;
             ago (not including hormonal therapy, Zometa, or other non-chemotherapy/radiation&#xD;
             cancer treatment at the discretion of the principal investigator)&#xD;
&#xD;
          -  Physically inactive, defined as not meeting 150 minutes or 2 hours and 30 minutes a&#xD;
             week of vigorous-intensity exercise&#xD;
&#xD;
          -  Overweight or obese, defined as having a body mass index (BMI) between 26 kg/m^2 and&#xD;
             42 kg/m^2, inclusive&#xD;
&#xD;
          -  Meeting criteria for participation in low to moderate risk exercise based on the&#xD;
             American College of Sports and Medicine (ACSM) guideline&#xD;
&#xD;
          -  Providing informed consent indicating understanding the investigational nature of this&#xD;
             study by signing an Independent Ethics Committee/Institutional Review Board approved&#xD;
             written informed consent form prior to receiving any study related procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Metastatic breast cancer&#xD;
&#xD;
          -  Orthopedic or neuromuscular disorders that preclude participation in exercise&#xD;
&#xD;
          -  Any history of myocardial infarction (MI), angina pectoris, or congestive heart&#xD;
             failure&#xD;
&#xD;
          -  High risk for moderate exercise based on ACSM risk classification&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
&#xD;
          -  Unwilling or unable to follow protocol requirements&#xD;
&#xD;
          -  Any condition which - in the investigator?s opinion - deems the participant an&#xD;
             unsuitable candidate to participate in this study&#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>Tracey O'Connor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Roswell Park Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>June 3, 2022</last_update_submitted>
  <last_update_submitted_qc>June 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Overweight</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/NCT03751449
org study id: i 67518
secondary id: NCI-2018-01704
secondary id: i 67518
nct id: NCT03751449
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This trial studies how well exercise and nutrition education work in improving physical
      function and quality of life in older breast cancer survivors. Exercise and nutrition
      education may help to improve the level of fitness, cardiovascular health, and quality of
      life in breast cancer survivors.
PRIMARY OBJECTIVES:

      I. To assess the effect of a home-based aerobic and resistance exercise and nutrition
      education intervention in overweight or obese, sedentary, older (65 years and above) breast
      cancer survivors on physical function (6-minute walk test) and quality of life compared to
      standard of care.

      SECONDARY OBJECTIVES:

      I. To assess the effect of a home-based aerobic and resistance exercise and nutrition
      education intervention on diet quality, sleep, anxiety, depression, source of motivation for
      exercise, and immune function in overweight or obese, sedentary, older (65 years and above)
      breast cancer survivors compared to standard of care.

      EXPLORATORY OBJECTIVES:

      I. To determine how body composition (dual X-ray absorptiometry [DEXA]) and weight
      maintenance are affected by a 12-week aerobic and resistance exercise training program among
      older (65 years and above), sedentary, overweight and obese breast cancer survivors.

      II. To compare differences in the above outcomes among older (65 years and above), sedentary,
      overweight and obese breast cancer survivors who completed a home-based aerobic and
      resistance exercise training program versus those who did not receive the intervention,
      standard of care.

      OUTLINE: Participants are randomized to 1 of 2 groups.

      GROUP I (ACTIVE TREATMENT): Participants complete a home-based aerobic and resistance
      exercise program and receive nutrition education for 12 weeks.

      GROUP II (WAITLIST): Participants are placed on a waitlist for 12 weeks and then complete a
      home-based aerobic and resistance exercise program and receive nutrition education for 12
      weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Activity levels for all participants will be collected using the Fitbit applications and a weekly activity log.
time frame: Up to 2 years
description: Will measure the effect on physical function (6-minute walk test). Activity levels for all participants will be collected using the Fitbit applications and/or a weekly activity log.
measure: Quality of life as assessed by the Self Geriatric Assessment Measure (GA-Self Assessment)
time frame: Up to 2 years
description: Will measure the effect of a home-based aerobic and resistance exercise and nutrition education intervention on quality of life.
measure: Diet quality as assessed by the ASA24 website
time frame: Up to 2 years
description: Will measure the effect of a home-based aerobic and resistance exercise and nutrition education intervention on diet quality.
measure: Sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)
time frame: Up to 2 years
description: The PSQI measures the quality and pattern of sleeps in adults. There are 19 items. Each item is weighted on a 0-3 interval scale.
measure: Anxiety and the effect of a home-based aerobic and resistance exercise and nutrition education intervention
time frame: Up to 2 years
description: Will measure anxiety as assessed by the State Trait Anxiety Inventory (STAI-Y1)e STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety
measure: motivation for exercise as assessed by the Behavioral Regulation for Exercise Questionnaire (BREQ-2)
time frame: Up to 2 years
description: A 19 item questionnaire that measures the stages of the self-determination continuum with respect to motivation to exercise with a 5 point Likert scale (0=not true for me, 4=very true for me)
measure: Centers for Epidemiologic Studies Depression Scale (CESD-R)
time frame: Up to 2 years
description: A self reported 20 item scale that measures depressive symptoms. A higher score denotes greater depressive symptoms.
arm group label: Group I (active treatment)
arm group type: Experimental
description: Participants complete a home-based aerobic and resistance exercise program and receive nutrition education for 12 weeks.
arm group label: Group II (waitlist)
arm group type: Active Comparator
description: Participants are placed on a waitlist for 12 weeks and then complete a home-based aerobic and resistance exercise program and receive nutrition education for 12 weeks.
intervention type: Other
intervention name: Educational Intervention
description: Receive nutrition education
arm group label: Group I (active treatment)
arm group label: Group II (waitlist)
other name: Education for Intervention
other name: Intervention by Education
other name: Intervention through Education
other name: Intervention, Educational
intervention type: Behavioral
intervention name: Exercise Intervention
description: Complete home-based aerobic and resistance exercise program
arm group label: Group I (active treatment)
arm group label: Group II (waitlist)
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Group I (active treatment)
arm group label: Group II (waitlist)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Group I (active treatment)
arm group label: Group II (waitlist)
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Tracey O'Connor
role: Principal Investigator
affiliation: Roswell Park Cancer Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Overweight