xml: <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/NCT06016725</url>
    </required_header>
    <id_info>
      <org_study_id>OSU-22329</org_study_id>
      <secondary_id>NCI-2023-04622</secondary_id>
      <secondary_id>R21AG078258</secondary_id>
      <nct_id>NCT06016725</nct_id>
    </id_info>
    <brief_title>Online Dietary and Resistance Training to Improve Physical Function in Older Cancer Survivors, E-PROOF Trial</brief_title>
    <acronym>E-PROOF</acronym>
    <official_title>E-PROOF: E-Intervention for Protein Intake and Resistance Training to Optimize Function</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ohio State University Comprehensive Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </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 phase I trial tests the feasibility, acceptability, and preliminary effectiveness of&#xD;
        online dietary and resistance training to improve physical function in older (greater than or&#xD;
        equal to 65-years old) cancer survivors. Declines in adequate protein and calorie intake&#xD;
        results in faster loss of muscle mass and physical functioning in older adults. A novel&#xD;
        approach to improving physical function in older cancer survivors (OCS) is to utilize online,&#xD;
        tailored education and counseling from registered dietitians and exercise scientists, to&#xD;
        improve dietary intake (protein intake, diet quality) and participation in resistance&#xD;
        exercise. The purpose of this study is to help researchers learn whether an online dietary&#xD;
        and resistance training intervention improves diet, exercise, physical function, and health&#xD;
        outcomes in OCS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVES:&#xD;
  &#xD;
        I. Determine the feasibility and acceptability of implementing a 12-week online dietary and&#xD;
        resistance training randomized trial with 70 older cancer survivors.&#xD;
  &#xD;
        II. Examine the preliminary efficacy of this 12-week online dietary and resistance training&#xD;
        intervention with the intervention participants.&#xD;
  &#xD;
        OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
  &#xD;
        ARM 1: Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3,&#xD;
        5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30&#xD;
        minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational&#xD;
        materials at baseline.&#xD;
  &#xD;
        ARM 2: Patients receive educational materials at baseline.&#xD;
  &#xD;
        After completion of study intervention, patients are followed up at 3 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</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>Physical function</measure>
      <time_frame>Up to 12 weeks post study completion</time_frame>
      <description>Measured by the Short Physical Performance Battery (SPPB) score. Efficacy will be based on 12 weeks. The SPPB score is a continuous variable, collected as the total score ranging from 0-12. Group differences in SPPB scores over the time will be tested using repeated measures analysis of variance. Using the planned contrasts command, we will investigate the changes in SPPB scores within each group, and between the intervention and control groups at end-of-study. Descriptive statistics and frequency distributions will be used to characterize the sample. To examine the effect of the intervention on the changes in physical function, a linear mixed effect model will be adopted.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Satisfaction of the delivery method and information provided by nutrition and exercise counseling sessions</measure>
      <time_frame>At 12 weeks</time_frame>
      <description>Percentage of participant satisfaction (&quot;satisfied&quot; and &quot;very satisfied&quot;) measured by a 5-item Likert-scale questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Study accrual rate</measure>
      <time_frame>Up to 9 months</time_frame>
      <description>Will be calculated by dividing the number of potential participants that passed screening by the total number of participants started in the study after appropriate informed consent procedures.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Study retention rate</measure>
      <time_frame>At baseline and 12 weeks</time_frame>
      <description>Will be calculated by dividing the total number of participants initiated by total number of participants in the study. Retention goal for this trial is 80%. If 80% (56/70) of participants are retained at end-of-study, the retention goal for this trial will be achieved. Overall retention rates and associated 95% confidence intervals will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Study adherence rate</measure>
      <time_frame>At baseline, 12 weeks, and 3-month follow-up</time_frame>
      <description>Participants will be determined to be adherent if they attend &gt;= 80% of the intervention sessions (in-person meetings with study staff and online intervention sessions). Overall adherence rates and associated 95% confidence intervals will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Muscle strength</measure>
      <time_frame>At baseline, 12 weeks, and 3-month follow-up</time_frame>
      <description>Handgrip strength will be measured in both hands using a hydraulic grip strength dynamometer. Change in participant outcome measures from baseline to end-of-study will be assessed in kilograms at the baseline and end of study visits.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dietary quality and protein intake</measure>
      <time_frame>At baseline and 12 weeks</time_frame>
      <description>Protein intake and dietary quality will be assessed by the National Cancer Institute's Diet History Questionnaire III using the Healthy Eating Index score ranging 0-100, with higher scores meaning higher diet quality. Change in participant outcome measures from baseline to end-of-study will be assessed using the Healthy Eating Index score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Resistance exercises</measure>
      <time_frame>At baseline and 12 weeks</time_frame>
      <description>Self-reported resistance exercise will be assessed using the revised version of The Godin-Shephard Leisure-Time Exercise Questionnaire modified to specifically capture self-reported resistance exercise participation, reported in frequency of days per week and duration in minutes. Change in participant outcome measures from baseline to end-of-study will be assessed using the reported frequency of days per week and duration in minutes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life (HRQoL) physical and emotional health scores</measure>
      <time_frame>At baseline and 12 weeks</time_frame>
      <description>RAND-36 Health Status Measure is comprised of 36 items which automatically create 8 subscales assessing multiple aspects of HRQoL. Physical and mental component summaries are created. All scores range from 0-100, with 100 as the highest. Change in participant outcome measures from baseline to end-of-study will be assessed using the RAND-36 Health Status Measure score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-efficacy for improving diet quality and increasing resistance training</measure>
      <time_frame>At baseline and 12 weeks</time_frame>
      <description>Self-efficacy will be measured via a 0-10 confidence scale rating the confidence of making exercise and diet changes, with 0 meaning not confident, 10 meaning very confident. Change in participant outcome measures from baseline to end-of-study will be assessed using the confidence scale rating.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Technology competency</measure>
      <time_frame>At baseline and 12 weeks</time_frame>
      <description>The 8-item eHealth Literacy Scale will measure knowledge, comfort, and perceived skills of engaging in eHealth at baseline and end-of-study. A 5-point Likert scale will be used. Change in participant outcome measures from baseline to end-of-study will be assessed using the 5-point Likert scale score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anthropometry body weight in kilograms</measure>
      <time_frame>At baseline and 12 weeks</time_frame>
      <description>Change in participant outcome measure body weight from baseline to end-of-study will be assessed using body weight in kilograms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anthropometry height in inches</measure>
      <time_frame>At baseline and 12 weeks</time_frame>
      <description>Change in participant outcome measure height from baseline to end-of-study will be assessed using height in inches.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anthropometry measuring waist circumference in centimeters</measure>
      <time_frame>At baseline and 12 weeks</time_frame>
      <description>Change in participant outcome measure waist circumference from baseline to end-of-study will be assessed using waist circumference in centimeters.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Anatomic Stage I Breast Cancer AJCC v8</condition>
    <condition>Anatomic Stage II Breast Cancer AJCC v8</condition>
    <condition>Anatomic Stage III Breast Cancer AJCC v8</condition>
    <condition>Stage I Colorectal Cancer AJCC v8</condition>
    <condition>Stage I Prostate Cancer AJCC v8</condition>
    <condition>Stage II Colorectal Cancer AJCC v8</condition>
    <condition>Stage II Prostate Cancer AJCC v8</condition>
    <condition>Stage III Colorectal Cancer AJCC v8</condition>
    <condition>Stage III Prostate Cancer AJCC v8</condition>
    <arm_group>
      <arm_group_label>Arm 1 (nutritional counseling, resistance training)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 2 (educational materials)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients receive educational materials at baseline.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Exercise Intervention</intervention_name>
      <description>Participate in online resistance training sessions</description>
      <arm_group_label>Arm 1 (nutritional counseling, resistance training)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Informational Intervention</intervention_name>
      <description>Given educational materials</description>
      <arm_group_label>Arm 1 (nutritional counseling, resistance training)</arm_group_label>
      <arm_group_label>Arm 2 (educational materials)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Nutritional Assessment</intervention_name>
      <description>Participate in online nutritional counseling</description>
      <arm_group_label>Arm 1 (nutritional counseling, resistance training)</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>Physical Performance Testing</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Arm 1 (nutritional counseling, resistance training)</arm_group_label>
      <arm_group_label>Arm 2 (educational materials)</arm_group_label>
      <other_name>Physical Fitness Testing</other_name>
      <other_name>Physical Function Testing</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Quality-of-Life Assessment</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Arm 1 (nutritional counseling, resistance training)</arm_group_label>
      <arm_group_label>Arm 2 (educational materials)</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>Arm 1 (nutritional counseling, resistance training)</arm_group_label>
      <arm_group_label>Arm 2 (educational materials)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  &gt;= 65 years of age&#xD;
  &#xD;
            -  A primary diagnosis of stage I-III breast, colorectal, and prostate cancer&#xD;
  &#xD;
            -  Completion of primary curative treatment&#xD;
  &#xD;
            -  Reported at least 1 physical function limitation on the RAND-36 Physical Function&#xD;
               Subscale (PFSS) (&quot;limited a little&quot;, &quot;limited a lot&quot;)&#xD;
  &#xD;
            -  No evidence of progressive disease or second cancers&#xD;
  &#xD;
            -  Community-dwelling&#xD;
  &#xD;
            -  Able to provide consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Currently receive cancer treatment (e.g., chemotherapy, radiation)&#xD;
  &#xD;
            -  Have liver and/or renal disease limiting their protein intake&#xD;
  &#xD;
            -  Are under the care of a Registered Dietician (RD)/nutritionist&#xD;
  &#xD;
            -  Participating in other diet/exercise interventions&#xD;
  &#xD;
            -  Consume protein supplements&#xD;
  &#xD;
            -  Have contraindications to unsupervised exercise (e.g., walker/wheelchair use)&#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>Jessica L Krok-Schoen, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ohio State University Comprehensive Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>The Ohio State Comprehensive Cancer Center</last_name>
      <phone>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>Jessica L. Krok-Schoen, PhD</last_name>
        <phone>614-366-9203</phone>
        <email>jessica.krok@osumc.edu</email>
      </contact>
      <investigator>
        <last_name>Jessica L. Krok-Schoen, PhD</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>September 2023</verification_date>
    <study_first_submitted>June 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 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>Jessica Krok-Schoen</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>Prostatic Neoplasms</mesh_term>
      <mesh_term>Colorectal Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016725
  org study id: OSU-22329
  secondary id: NCI-2023-04622
  secondary id: R21AG078258
  nct id: NCT06016725
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This phase I trial tests the feasibility, acceptability, and preliminary effectiveness of
        online dietary and resistance training to improve physical function in older (greater than or
        equal to 65-years old) cancer survivors. Declines in adequate protein and calorie intake
        results in faster loss of muscle mass and physical functioning in older adults. A novel
        approach to improving physical function in older cancer survivors (OCS) is to utilize online,
        tailored education and counseling from registered dietitians and exercise scientists, to
        improve dietary intake (protein intake, diet quality) and participation in resistance
        exercise. The purpose of this study is to help researchers learn whether an online dietary
        and resistance training intervention improves diet, exercise, physical function, and health
        outcomes in OCS.
  PRIMARY OBJECTIVES:
  
        I. Determine the feasibility and acceptability of implementing a 12-week online dietary and
        resistance training randomized trial with 70 older cancer survivors.
  
        II. Examine the preliminary efficacy of this 12-week online dietary and resistance training
        intervention with the intervention participants.
  
        OUTLINE: Patients are randomized to 1 of 2 arms.
  
        ARM 1: Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3,
        5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30
        minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational
        materials at baseline.
  
        ARM 2: Patients receive educational materials at baseline.
  
        After completion of study intervention, patients are followed up at 3 months.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Physical function
  time frame: Up to 12 weeks post study completion
  description: Measured by the Short Physical Performance Battery (SPPB) score. Efficacy will be based on 12 weeks. The SPPB score is a continuous variable, collected as the total score ranging from 0-12. Group differences in SPPB scores over the time will be tested using repeated measures analysis of variance. Using the planned contrasts command, we will investigate the changes in SPPB scores within each group, and between the intervention and control groups at end-of-study. Descriptive statistics and frequency distributions will be used to characterize the sample. To examine the effect of the intervention on the changes in physical function, a linear mixed effect model will be adopted.
  measure: Satisfaction of the delivery method and information provided by nutrition and exercise counseling sessions
  time frame: At 12 weeks
  description: Percentage of participant satisfaction ("satisfied" and "very satisfied") measured by a 5-item Likert-scale questionnaire
  measure: Study accrual rate
  time frame: Up to 9 months
  description: Will be calculated by dividing the number of potential participants that passed screening by the total number of participants started in the study after appropriate informed consent procedures.
  measure: Study retention rate
  time frame: At baseline and 12 weeks
  description: Will be calculated by dividing the total number of participants initiated by total number of participants in the study. Retention goal for this trial is 80%. If 80% (56/70) of participants are retained at end-of-study, the retention goal for this trial will be achieved. Overall retention rates and associated 95% confidence intervals will be reported.
  measure: Study adherence rate
  time frame: At baseline, 12 weeks, and 3-month follow-up
  description: Participants will be determined to be adherent if they attend >= 80% of the intervention sessions (in-person meetings with study staff and online intervention sessions). Overall adherence rates and associated 95% confidence intervals will be reported.
  measure: Muscle strength
  time frame: At baseline, 12 weeks, and 3-month follow-up
  description: Handgrip strength will be measured in both hands using a hydraulic grip strength dynamometer. Change in participant outcome measures from baseline to end-of-study will be assessed in kilograms at the baseline and end of study visits.
  measure: Dietary quality and protein intake
  time frame: At baseline and 12 weeks
  description: Protein intake and dietary quality will be assessed by the National Cancer Institute's Diet History Questionnaire III using the Healthy Eating Index score ranging 0-100, with higher scores meaning higher diet quality. Change in participant outcome measures from baseline to end-of-study will be assessed using the Healthy Eating Index score.
  measure: Resistance exercises
  time frame: At baseline and 12 weeks
  description: Self-reported resistance exercise will be assessed using the revised version of The Godin-Shephard Leisure-Time Exercise Questionnaire modified to specifically capture self-reported resistance exercise participation, reported in frequency of days per week and duration in minutes. Change in participant outcome measures from baseline to end-of-study will be assessed using the reported frequency of days per week and duration in minutes.
  measure: Health-related quality of life (HRQoL) physical and emotional health scores
  time frame: At baseline and 12 weeks
  description: RAND-36 Health Status Measure is comprised of 36 items which automatically create 8 subscales assessing multiple aspects of HRQoL. Physical and mental component summaries are created. All scores range from 0-100, with 100 as the highest. Change in participant outcome measures from baseline to end-of-study will be assessed using the RAND-36 Health Status Measure score.
  measure: Self-efficacy for improving diet quality and increasing resistance training
  time frame: At baseline and 12 weeks
  description: Self-efficacy will be measured via a 0-10 confidence scale rating the confidence of making exercise and diet changes, with 0 meaning not confident, 10 meaning very confident. Change in participant outcome measures from baseline to end-of-study will be assessed using the confidence scale rating.
  measure: Technology competency
  time frame: At baseline and 12 weeks
  description: The 8-item eHealth Literacy Scale will measure knowledge, comfort, and perceived skills of engaging in eHealth at baseline and end-of-study. A 5-point Likert scale will be used. Change in participant outcome measures from baseline to end-of-study will be assessed using the 5-point Likert scale score.
  measure: Anthropometry body weight in kilograms
  time frame: At baseline and 12 weeks
  description: Change in participant outcome measure body weight from baseline to end-of-study will be assessed using body weight in kilograms.
  measure: Anthropometry height in inches
  time frame: At baseline and 12 weeks
  description: Change in participant outcome measure height from baseline to end-of-study will be assessed using height in inches.
  measure: Anthropometry measuring waist circumference in centimeters
  time frame: At baseline and 12 weeks
  description: Change in participant outcome measure waist circumference from baseline to end-of-study will be assessed using waist circumference in centimeters.
  arm group label: Arm 1 (nutritional counseling, resistance training)
  arm group type: Experimental
  description: Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.
  arm group label: Arm 2 (educational materials)
  arm group type: Active Comparator
  description: Patients receive educational materials at baseline.
  intervention type: Other
  intervention name: Exercise Intervention
  description: Participate in online resistance training sessions
  arm group label: Arm 1 (nutritional counseling, resistance training)
  intervention type: Other
  intervention name: Informational Intervention
  description: Given educational materials
  arm group label: Arm 1 (nutritional counseling, resistance training)
  arm group label: Arm 2 (educational materials)
  intervention type: Other
  intervention name: Nutritional Assessment
  description: Participate in online nutritional counseling
  arm group label: Arm 1 (nutritional counseling, resistance training)
  other name: Dietary Assessment
  other name: dietary counseling
  other name: nutritional counseling
  intervention type: Other
  intervention name: Physical Performance Testing
  description: Ancillary studies
  arm group label: Arm 1 (nutritional counseling, resistance training)
  arm group label: Arm 2 (educational materials)
  other name: Physical Fitness Testing
  other name: Physical Function Testing
  intervention type: Other
  intervention name: Quality-of-Life Assessment
  description: Ancillary studies
  arm group label: Arm 1 (nutritional counseling, resistance training)
  arm group label: Arm 2 (educational materials)
  other name: Quality of Life Assessment
  intervention type: Other
  intervention name: Questionnaire Administration
  description: Ancillary studies
  arm group label: Arm 1 (nutritional counseling, resistance training)
  arm group label: Arm 2 (educational materials)
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jessica L Krok-Schoen, PhD
  role: Principal Investigator
  affiliation: Ohio State University Comprehensive Cancer Center
  last name: The Ohio State Comprehensive Cancer Center
  phone: 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: Jessica Krok-Schoen
  investigator title: Principal Investigator
  mesh term: Breast Neoplasms
  mesh term: Prostatic Neoplasms
  mesh term: Colorectal Neoplasms
  sharing ipd: No