<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/NCT02256137</url>
  </required_header>
  <id_info>
    <org_study_id>FRAILTY</org_study_id>
    <secondary_id>R01CA174851</secondary_id>
    <nct_id>NCT02256137</nct_id>
  </id_info>
  <brief_title>A Longitudinal Assessment of Frailty in Young Adult Survivors of Childhood Cancer</brief_title>
  <official_title>A Longitudinal Assessment of Frailty in Young Adult Survivors of Childhood Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Jude Children's Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Jude Children's Research Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Advances in cancer therapies have led to increasing numbers of adult survivors of pediatric&#xD;
      malignancy. Unfortunately, treatment of childhood cancer continues to require agents designed&#xD;
      to destroy malignant cell lines, and normal tissue is not always spared. While early&#xD;
      treatment- related organ specific toxicities are not always apparent, many childhood cancer&#xD;
      survivors report symptoms that interfere with daily life, including exercise induced&#xD;
      shortness of breath, fatigue and reduced capacity to participate in physical activity. These&#xD;
      symptoms may be a hallmark of premature aging, or frailty. Frailty is a phenotype most&#xD;
      commonly described in older adults; it indicates persons who are highly vulnerable to adverse&#xD;
      health outcomes. Frailty may help explain why nearly two thirds of childhood cancer survivors&#xD;
      have at least one severe chronic health condition 30 years from diagnosis, why childhood&#xD;
      cancer survivors are more likely than peers to be hospitalized for non-obstetrical reasons,&#xD;
      and why they have mortality rates more than eight times higher than age-and-gender matched&#xD;
      members of the general population.&#xD;
&#xD;
      Frailty is a valuable construct because it can be distinguished from disability and&#xD;
      co-morbidity, and is designed to capture pre-clinical states of physiologic vulnerability&#xD;
      that identify individuals most at risk for adverse health outcomes. These investigators have&#xD;
      recently presented data indicating that impaired fitness is present in survivors of childhood&#xD;
      acute lymphoblastic leukemia, brain tumor and Hodgkin lymphoma. This is relevant because&#xD;
      frailty, characterized by a cluster of five measurements of physical fitness, is predictive&#xD;
      of chronic disease onset, frequent hospitalization, and eventually mortality in both the&#xD;
      elderly and in persons with chronic conditions. Using a frailty phenotype as an early&#xD;
      predictor of later chronic disease onset will allow identification of childhood and&#xD;
      adolescent cancer survivors at greatest risk for adverse health. An early indicator of those&#xD;
      at risk for adverse health will allow researchers to test, and clinicians to provide,&#xD;
      specific interventions designed to remediate functional loss, and prevent or delay onset of&#xD;
      chronic health conditions. The investigators goals include characterizing physical frailty&#xD;
      over a five year time span in a population of young adult survivors of childhood cancer, as&#xD;
      well as assessing the association between frailty and the increase in the number and severity&#xD;
      of chronic health conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
        -  Evaluate the change in the proportion of young adult cancer survivors who are frail from&#xD;
           baseline to a point five years later.&#xD;
&#xD;
        -  Evaluate the association between frailty and worsening of chronic health conditions.&#xD;
&#xD;
        -  Describe the association between demographic and treatment factors and risk for&#xD;
           prevalent frailty.&#xD;
&#xD;
        -  Estimate the effects of physical activity, diet and smoking on risk for prevalent&#xD;
           frailty.&#xD;
&#xD;
      Participants will complete a study questionnaire to assess social support, complete body&#xD;
      composition studies, walking speed test, physical activity monitoring, and difficulties in&#xD;
      daily activities due to health condition. In addition, any data collected as part of the&#xD;
      SJLIFE protocol, including questionnaires, medical history and physical, height and weight&#xD;
      measurements, physical functioning assessment results (i.e. hand grip strength), and&#xD;
      neuropsychological evaluation results, may also be used as part of the evaluation for this&#xD;
      study. The information collected for this study will be compared to information collected at&#xD;
      a previous SJLIFE clinic visit within the previous 6 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 8, 2014</start_date>
  <completion_date type="Anticipated">August 17, 2025</completion_date>
  <primary_completion_date type="Anticipated">August 17, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in proportion of participants who are frail from baseline to 5 years later</measure>
    <time_frame>Baseline and 5 years later (± 1 year)</time_frame>
    <description>We will use McNemar's test to assess if the prevalence of frailty has significantly increased over the 5-year time period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Association between frailty at baseline and worsening of chronic health conditions 5 years later</measure>
    <time_frame>Baseline and 5 years later (± 1 year)</time_frame>
    <description>The event of interest, worsening of chronic condition, will be defined as binary outcome which will take value of 1 if, compared to baseline evaluation, a survivor develops a new chronic condition (grade ≥3) or if the chronic condition worsens over the 5-year time period (i.e. goes from grades 1-2 to grade ≥3 or dies due to chronic condition); otherwise it will take a value of 0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Association between demographic and treatment factors and lifestyle on prevalent frailty.</measure>
    <time_frame>5 years (± 1 year) after baseline evaluation</time_frame>
    <description>We will examine the association in a path model (all variables are measured) as lifestyle factors are likely to be mediators of the association between treatment and the frailty outcome at the five year time point. Sex, age at diagnosis, radiation exposure, specific chemotherapy agent doses, and age will be included in the initial theoretical model as exogenous variables and physical activity, diet, smoking status and frailty will be included as endogenous variables. Other variables, like medication use, baseline chronic disease, etc. will be evaluated for their contributions to the outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of physical activity, diet and smoking on prevalent frailty</measure>
    <time_frame>5 years (± 1 year) after baseline evaluation</time_frame>
    <description>We will examine the association in a path model (all variables are measured) as lifestyle factors are likely to be mediators of the association between treatment and the frailty outcome at the five year time point. Sex, age at diagnosis, radiation exposure, specific chemotherapy agent doses, and age will be included in the initial theoretical model as exogenous variables and physical activity, diet, smoking status and frailty will be included as endogenous variables. Other variables, like medication use, baseline chronic disease, etc. will be evaluated for their contributions to the outcomes.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1468</enrollment>
  <condition>Acute Lymphoblastic Leukemia</condition>
  <condition>Brain Tumor</condition>
  <condition>Hodgkin Lymphoma</condition>
  <arm_group>
    <arm_group_label>Childhood Cancer Survivors</arm_group_label>
    <description>This study will evaluate 1493 members of the St. Jude Lifetime Cohort Study (SJLIFE) who have completed a baseline functional assessment six or less years ago when 18-45 years of age.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        This study will evaluate 1493 members of the St. Jude Lifetime Cohort Study (SJLIFE) who&#xD;
        have completed a baseline functional assessment six or less years ago when 18-45 years of&#xD;
        age.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrollment on the SJLIFE protocol.&#xD;
&#xD;
          -  Completed baseline assessment between July 1, 2008 and June 30, 2015.&#xD;
&#xD;
          -  Completed the baseline assessment between the ages of 18-45.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently pregnant (assessed by serum pregnancy test).&#xD;
&#xD;
          -  Currently receiving treatment for cancer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kirsten Ness, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Jude Children's Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Jude Children's Research Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.stjude.org</url>
    <description>St. Jude Children's Research Hospital</description>
  </link>
  <link>
    <url>http://www.stjude.org/protocols</url>
    <description>Clinical Trials Open at St. Jude</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>July 5, 2023</last_update_submitted>
  <last_update_submitted_qc>July 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Frailty phenotype</keyword>
  <keyword>Physical fitness</keyword>
  <keyword>Childhood cancer</keyword>
  <keyword>Late onset of chronic health conditions</keyword>
  <keyword>Physical frailty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Frailty</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/NCT02256137
org study id: FRAILTY
secondary id: R01CA174851
nct id: NCT02256137
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Advances in cancer therapies have led to increasing numbers of adult survivors of pediatric
      malignancy. Unfortunately, treatment of childhood cancer continues to require agents designed
      to destroy malignant cell lines, and normal tissue is not always spared. While early
      treatment- related organ specific toxicities are not always apparent, many childhood cancer
      survivors report symptoms that interfere with daily life, including exercise induced
      shortness of breath, fatigue and reduced capacity to participate in physical activity. These
      symptoms may be a hallmark of premature aging, or frailty. Frailty is a phenotype most
      commonly described in older adults; it indicates persons who are highly vulnerable to adverse
      health outcomes. Frailty may help explain why nearly two thirds of childhood cancer survivors
      have at least one severe chronic health condition 30 years from diagnosis, why childhood
      cancer survivors are more likely than peers to be hospitalized for non-obstetrical reasons,
      and why they have mortality rates more than eight times higher than age-and-gender matched
      members of the general population.

      Frailty is a valuable construct because it can be distinguished from disability and
      co-morbidity, and is designed to capture pre-clinical states of physiologic vulnerability
      that identify individuals most at risk for adverse health outcomes. These investigators have
      recently presented data indicating that impaired fitness is present in survivors of childhood
      acute lymphoblastic leukemia, brain tumor and Hodgkin lymphoma. This is relevant because
      frailty, characterized by a cluster of five measurements of physical fitness, is predictive
      of chronic disease onset, frequent hospitalization, and eventually mortality in both the
      elderly and in persons with chronic conditions. Using a frailty phenotype as an early
      predictor of later chronic disease onset will allow identification of childhood and
      adolescent cancer survivors at greatest risk for adverse health. An early indicator of those
      at risk for adverse health will allow researchers to test, and clinicians to provide,
      specific interventions designed to remediate functional loss, and prevent or delay onset of
      chronic health conditions. The investigators goals include characterizing physical frailty
      over a five year time span in a population of young adult survivors of childhood cancer, as
      well as assessing the association between frailty and the increase in the number and severity
      of chronic health conditions.
PRIMARY OBJECTIVES:

        -  Evaluate the change in the proportion of young adult cancer survivors who are frail from
           baseline to a point five years later.

        -  Evaluate the association between frailty and worsening of chronic health conditions.

        -  Describe the association between demographic and treatment factors and risk for
           prevalent frailty.

        -  Estimate the effects of physical activity, diet and smoking on risk for prevalent
           frailty.

      Participants will complete a study questionnaire to assess social support, complete body
      composition studies, walking speed test, physical activity monitoring, and difficulties in
      daily activities due to health condition. In addition, any data collected as part of the
      SJLIFE protocol, including questionnaires, medical history and physical, height and weight
      measurements, physical functioning assessment results (i.e. hand grip strength), and
      neuropsychological evaluation results, may also be used as part of the evaluation for this
      study. The information collected for this study will be compared to information collected at
      a previous SJLIFE clinic visit within the previous 6 years.
observational model: Cohort
time perspective: Prospective
measure: Change in proportion of participants who are frail from baseline to 5 years later
time frame: Baseline and 5 years later (± 1 year)
description: We will use McNemar's test to assess if the prevalence of frailty has significantly increased over the 5-year time period.
measure: Association between frailty at baseline and worsening of chronic health conditions 5 years later
time frame: Baseline and 5 years later (± 1 year)
description: The event of interest, worsening of chronic condition, will be defined as binary outcome which will take value of 1 if, compared to baseline evaluation, a survivor develops a new chronic condition (grade ≥3) or if the chronic condition worsens over the 5-year time period (i.e. goes from grades 1-2 to grade ≥3 or dies due to chronic condition); otherwise it will take a value of 0.
measure: Association between demographic and treatment factors and lifestyle on prevalent frailty.
time frame: 5 years (± 1 year) after baseline evaluation
description: We will examine the association in a path model (all variables are measured) as lifestyle factors are likely to be mediators of the association between treatment and the frailty outcome at the five year time point. Sex, age at diagnosis, radiation exposure, specific chemotherapy agent doses, and age will be included in the initial theoretical model as exogenous variables and physical activity, diet, smoking status and frailty will be included as endogenous variables. Other variables, like medication use, baseline chronic disease, etc. will be evaluated for their contributions to the outcomes.
measure: Effects of physical activity, diet and smoking on prevalent frailty
time frame: 5 years (± 1 year) after baseline evaluation
description: We will examine the association in a path model (all variables are measured) as lifestyle factors are likely to be mediators of the association between treatment and the frailty outcome at the five year time point. Sex, age at diagnosis, radiation exposure, specific chemotherapy agent doses, and age will be included in the initial theoretical model as exogenous variables and physical activity, diet, smoking status and frailty will be included as endogenous variables. Other variables, like medication use, baseline chronic disease, etc. will be evaluated for their contributions to the outcomes.
arm group label: Childhood Cancer Survivors
description: This study will evaluate 1493 members of the St. Jude Lifetime Cohort Study (SJLIFE) who have completed a baseline functional assessment six or less years ago when 18-45 years of age.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Kirsten Ness, PT, PhD
role: Principal Investigator
affiliation: St. Jude Children's Research Hospital
facility: 
country: United States
url: http://www.stjude.org
description: St. Jude Children's Research Hospital
url: http://www.stjude.org/protocols
description: Clinical Trials Open at St. Jude
responsible party type: Sponsor
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Frailty