<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/NCT04454086</url>
  </required_header>
  <id_info>
    <org_study_id>OSU-17122</org_study_id>
    <secondary_id>NCI-2019-00570</secondary_id>
    <nct_id>NCT04454086</nct_id>
  </id_info>
  <brief_title>Exercise and Diet Counseling Program in Improving Quality of Life in Stage I-III Breast Cancer Survivors</brief_title>
  <official_title>Healthy New Albany: Breast Cancer Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University Comprehensive Cancer Center</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>
      This trial studies the benefits of an exercise and diet counseling program in improving&#xD;
      quality of life in stage I-III breast cancer survivors. Exercise and diet counseling may help&#xD;
      improve weight loss and relevant clinical and patient-reported outcomes in overweight or&#xD;
      obese breast cancer survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the feasibility of delivering a community-based, comprehensive lifestyle&#xD;
      weight management (LWM) intervention to 20 overweight or obese breast cancer (BC) survivors.&#xD;
&#xD;
      II. Explore preliminary efficacy of the community-based, comprehensive LWM intervention for&#xD;
      producing meaningful improvements in select clinically-relevant anthropometric, fitness,&#xD;
      functional, and patient-reported outcomes in BC survivors.&#xD;
&#xD;
      III. Provide the effect size estimates necessary to inform the design of a subsequent R01&#xD;
      application addressing a large scale, optimally powered, randomized controlled,&#xD;
      community-based LWM comparative efficacy intervention trial targeting weight loss in BC&#xD;
      survivors.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo aerobic exercise over 10-30 minutes and resistance exercise comprising 1-3&#xD;
      sets of 8-12 repetitions of 10 different exercises over 1 hour for 24 weeks. Patients also&#xD;
      receive behavioral activity counseling once a week and nutritional counseling over 30 minutes&#xD;
      for 10 sessions after center-based exercise sessions during months 1-2.&#xD;
&#xD;
      After completion of study, patients are followed up at 3 and 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 6, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mobility disability</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Assessed with the 400-meter walk test. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =&lt; 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the last observation carried forward (LOCF) approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported physical function</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Measure with the abbreviated Late-Life Function and Disability Inventory. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =&lt; 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective functional performance</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Using 3 valid and reliable timed performance-related mobility tasks: 400-meter walk (the primary outcome), stair-climb, and lift and carry task. Assessments of Mobility-Related Self-Efficacy to complete each functional task will also be completed with the tests. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =&lt; 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance deficits assessment</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Estimate standing and reaching balance using a balance plate. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =&lt; 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscular strength assessement</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Using standardized one-repetition maximum testing protocols for the chest press and leg extension exercises. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =&lt; 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Dual-energy x-ray absorptiometry (DEXA) for all outcome measures. The DEXA scans were used to determine total body composition including bone-mineral density, as well as, percentage body fat and fat-free mass for all body regions. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =&lt; 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Measured to the nearest 0.1 kilogram using a calibrated and certified balance beam scale. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =&lt; 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QOL) surveys using the Rand Short Form Health Survey (SF-12)</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>The SF-12 questionnaire is a 12 -item scale that assesses the Physical (PCS) and Mental Health (MCS) composite summary scales composed of 6 items each on a 5-point rating scale. PCS and MCS scores range from 0-30 with higher scores indicating more favorable outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QOL) survey using the Functional Assessment of Cancer Therapy- breast (FACT-B).</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>The Functional Assessment of Cancer Therapy-Breast is a disease specific measures including the satisfaction with life scale. The Functional Assessment of Cancer Therapy-breast will be used to analyze sample T-tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Fatigue Inventory (BFI)</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>The Brief Fatigue Inventory is a 9-item scale scored on an 11-point rating scale ranging from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores represent greater levels of fatigue. In this form, there are 5 overarching questions. The first one asks, &quot;Have you felt unusually tired or fatigued in the last week?&quot; which is simply a Yes or No response. The next 4 questions then have answers in terms of a scale. The next 3 have the following sliding scale: 0= No Fatigue, 10= As bad as you can imagine, with 1-9 each representing intermediate responses. For the last question, the scale is: 0= Does not interfere, 10= Completely interferes, with 1-9 representing individual intermediate responses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence assessment</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Will be defined via attendance at prescribed sessions and will be assessed using exercise logs, upon which participants will record all exercise performed at the center or independently. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =&lt; 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility measures</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Descriptive statistics for assessments of recruitment rates, adverse events, and retention rates will be calculated prospectively throughout the trial. Feasibility assessments of participants? satisfaction with the exercise and dietary intervention will also be completed at the end of the 24-week intervention. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =&lt; 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</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>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>Supportive care (exercise program, counseling)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo aerobic exercise over 10-30 minutes and resistance exercise comprising 1-3 sets of 8-12 repetitions of 10 different exercises over 1 hour for 24 weeks. Patients also receive behavioral activity counseling once a week and nutritional counseling over 30 minutes for 10 sessions after center-based exercise sessions during months 1-2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic Exercise</intervention_name>
    <description>Undergo aerobic exercise</description>
    <arm_group_label>Supportive care (exercise program, counseling)</arm_group_label>
    <other_name>Aerobic Activity</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise Counseling</intervention_name>
    <description>Receive behavioral activity counseling</description>
    <arm_group_label>Supportive care (exercise program, counseling)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutritional Assessment</intervention_name>
    <description>Receive nutritional counseling</description>
    <arm_group_label>Supportive care (exercise program, counseling)</arm_group_label>
    <other_name>Dietary Assessment</other_name>
    <other_name>dietary counseling</other_name>
    <other_name>nutritional counseling</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive care (exercise program, counseling)</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>Supportive care (exercise program, counseling)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resistance Training</intervention_name>
    <description>Undergo resistance exercises</description>
    <arm_group_label>Supportive care (exercise program, counseling)</arm_group_label>
    <other_name>Strength Training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female breast cancer (stage I-III), within (w/in) 60 months after cessation of active&#xD;
             treatment (surgery, chemotherapy, radiation), and may be on continued hormone therapy.&#xD;
&#xD;
          -  Overweight/obese (body mass index [BMI] &gt; 25).&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent.&#xD;
&#xD;
          -  Willing and physically able to participate in physical activity.&#xD;
&#xD;
          -  Obtain physician consent via primary care physician and/or treating oncologist.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &gt; 60 months post breast cancer therapy.&#xD;
&#xD;
          -  Contraindications to exercise.&#xD;
&#xD;
          -  Diagnosis of cancer other than breast that is receiving active treatment.&#xD;
&#xD;
          -  Currently receiving chemotherapy/radiation.&#xD;
&#xD;
          -  Musculoskeletal/neurological disorder inhibiting them from safe exercise.&#xD;
&#xD;
          -  Pregnant or nursing women.&#xD;
&#xD;
          -  Unable to give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian C Focht, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University Comprehensive Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>The Ohio State University Comprehensive Cancer Center</last_name>
    <phone>1-800-293-5066</phone>
    <email>OSUCCCClinicaltrials@osumc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ohio State University Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brian C. Focht</last_name>
      <phone>614-292-2165</phone>
      <email>focht.10@osu.edu</email>
    </contact>
    <investigator>
      <last_name>Brian C. Focht</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://cancer.osu.edu</url>
    <description>The Jamesline</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 16, 2019</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University Comprehensive Cancer Center</investigator_affiliation>
    <investigator_full_name>Brian Focht</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </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>
  <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/NCT04454086
org study id: OSU-17122
secondary id: NCI-2019-00570
nct id: NCT04454086
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This trial studies the benefits of an exercise and diet counseling program in improving
      quality of life in stage I-III breast cancer survivors. Exercise and diet counseling may help
      improve weight loss and relevant clinical and patient-reported outcomes in overweight or
      obese breast cancer survivors.
PRIMARY OBJECTIVES:

      I. To determine the feasibility of delivering a community-based, comprehensive lifestyle
      weight management (LWM) intervention to 20 overweight or obese breast cancer (BC) survivors.

      II. Explore preliminary efficacy of the community-based, comprehensive LWM intervention for
      producing meaningful improvements in select clinically-relevant anthropometric, fitness,
      functional, and patient-reported outcomes in BC survivors.

      III. Provide the effect size estimates necessary to inform the design of a subsequent R01
      application addressing a large scale, optimally powered, randomized controlled,
      community-based LWM comparative efficacy intervention trial targeting weight loss in BC
      survivors.

      OUTLINE:

      Patients undergo aerobic exercise over 10-30 minutes and resistance exercise comprising 1-3
      sets of 8-12 repetitions of 10 different exercises over 1 hour for 24 weeks. Patients also
      receive behavioral activity counseling once a week and nutritional counseling over 30 minutes
      for 10 sessions after center-based exercise sessions during months 1-2.

      After completion of study, patients are followed up at 3 and 6 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Mobility disability
time frame: Baseline up to 6 months
description: Assessed with the 400-meter walk test. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the last observation carried forward (LOCF) approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
measure: Self-reported physical function
time frame: Baseline up to 6 months
description: Measure with the abbreviated Late-Life Function and Disability Inventory. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
measure: Objective functional performance
time frame: Baseline up to 6 months
description: Using 3 valid and reliable timed performance-related mobility tasks: 400-meter walk (the primary outcome), stair-climb, and lift and carry task. Assessments of Mobility-Related Self-Efficacy to complete each functional task will also be completed with the tests. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
measure: Balance deficits assessment
time frame: Baseline up to 6 months
description: Estimate standing and reaching balance using a balance plate. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
measure: Muscular strength assessement
time frame: Baseline up to 6 months
description: Using standardized one-repetition maximum testing protocols for the chest press and leg extension exercises. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
measure: Body composition
time frame: Baseline up to 6 months
description: Dual-energy x-ray absorptiometry (DEXA) for all outcome measures. The DEXA scans were used to determine total body composition including bone-mineral density, as well as, percentage body fat and fat-free mass for all body regions. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
measure: Body weight
time frame: Baseline up to 6 months
description: Measured to the nearest 0.1 kilogram using a calibrated and certified balance beam scale. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
measure: Quality of life (QOL) surveys using the Rand Short Form Health Survey (SF-12)
time frame: Baseline up to 6 months
description: The SF-12 questionnaire is a 12 -item scale that assesses the Physical (PCS) and Mental Health (MCS) composite summary scales composed of 6 items each on a 5-point rating scale. PCS and MCS scores range from 0-30 with higher scores indicating more favorable outcomes.
measure: Quality of life (QOL) survey using the Functional Assessment of Cancer Therapy- breast (FACT-B).
time frame: Baseline up to 6 months
description: The Functional Assessment of Cancer Therapy-Breast is a disease specific measures including the satisfaction with life scale. The Functional Assessment of Cancer Therapy-breast will be used to analyze sample T-tests.
measure: Brief Fatigue Inventory (BFI)
time frame: Baseline up to 6 months
description: The Brief Fatigue Inventory is a 9-item scale scored on an 11-point rating scale ranging from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores represent greater levels of fatigue. In this form, there are 5 overarching questions. The first one asks, "Have you felt unusually tired or fatigued in the last week?" which is simply a Yes or No response. The next 4 questions then have answers in terms of a scale. The next 3 have the following sliding scale: 0= No Fatigue, 10= As bad as you can imagine, with 1-9 each representing intermediate responses. For the last question, the scale is: 0= Does not interfere, 10= Completely interferes, with 1-9 representing individual intermediate responses.
measure: Adherence assessment
time frame: Up to 6 months
description: Will be defined via attendance at prescribed sessions and will be assessed using exercise logs, upon which participants will record all exercise performed at the center or independently. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
measure: Feasibility measures
time frame: Up to 24 weeks
description: Descriptive statistics for assessments of recruitment rates, adverse events, and retention rates will be calculated prospectively throughout the trial. Feasibility assessments of participants? satisfaction with the exercise and dietary intervention will also be completed at the end of the 24-week intervention. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
arm group label: Supportive care (exercise program, counseling)
arm group type: Experimental
description: Patients undergo aerobic exercise over 10-30 minutes and resistance exercise comprising 1-3 sets of 8-12 repetitions of 10 different exercises over 1 hour for 24 weeks. Patients also receive behavioral activity counseling once a week and nutritional counseling over 30 minutes for 10 sessions after center-based exercise sessions during months 1-2.
intervention type: Other
intervention name: Aerobic Exercise
description: Undergo aerobic exercise
arm group label: Supportive care (exercise program, counseling)
other name: Aerobic Activity
intervention type: Other
intervention name: Exercise Counseling
description: Receive behavioral activity counseling
arm group label: Supportive care (exercise program, counseling)
intervention type: Other
intervention name: Nutritional Assessment
description: Receive nutritional counseling
arm group label: Supportive care (exercise program, counseling)
other name: Dietary Assessment
other name: dietary counseling
other name: nutritional counseling
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Supportive care (exercise program, counseling)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Supportive care (exercise program, counseling)
intervention type: Other
intervention name: Resistance Training
description: Undergo resistance exercises
arm group label: Supportive care (exercise program, counseling)
other name: Strength Training
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: No
last name: Brian C Focht, PhD
role: Principal Investigator
affiliation: Ohio State University Comprehensive Cancer Center
last name: The Ohio State University Comprehensive Cancer Center
phone: 1-800-293-5066
email: OSUCCCClinicaltrials@osumc.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://cancer.osu.edu
description: The Jamesline
responsible party type: Principal Investigator
investigator affiliation: Ohio State University Comprehensive Cancer Center
investigator full name: Brian Focht
investigator title: Principal Investigator
mesh term: Breast Neoplasms
mesh term: Overweight
sharing ipd: No