<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/NCT01673243</url>
  </required_header>
  <id_info>
    <org_study_id>XPD12-110 SMOBAN</org_study_id>
    <nct_id>NCT01673243</nct_id>
  </id_info>
  <brief_title>Parent Willingness to Participate in Tobacco Trials in the Pediatric Clinical Setting</brief_title>
  <official_title>Tobacco Trials at St. Jude: Parent Willingness to Participate Among Families of Children With Cancer, Sickle Cell Disease, or Survivors of Childhood Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Jude Children's Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Jude Children's Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Little is known about what factors influence parental decisions to participate or to decline&#xD;
      participation in tobacco trials offered in the pediatric clinical setting. Further, it is&#xD;
      unclear what proportion of parents treated in our setting would elect to receive formal&#xD;
      assistance with quitting smoking or consider alternative approaches that could facilitate&#xD;
      eventual smoking cessation. While the recommendation to parents is generally to quit smoking,&#xD;
      some may be unwilling or unable to quit and prefer more achievable alternative treatment&#xD;
      goals. Some parent smokers may be unlikely to participate in an intervention aimed only at&#xD;
      cessation but would be willing to participate in an intervention focused on establishing&#xD;
      smoke-free environments for their child. Parents are typically not offered a choice regarding&#xD;
      the type of intervention they receive and many interventions are not tailored to their&#xD;
      readiness to quit smoking or designed to reach multiple family members in the home who may&#xD;
      also smoke. Quitting smoking and establishing smoke-free homes and cars are distinct, yet&#xD;
      challenging, goals for parents and families. Both approaches can directly, or indirectly,&#xD;
      help parents to quit smoking, reduce the child's exposure to second-hand smoke (SHS), and&#xD;
      initiate an important dialogue with families about tobacco control. How parental&#xD;
      acceptability of smoking interventions is affected by the context of their child's treatment&#xD;
      for cancer or SCD, as well as survivorship, warrants further study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following a Behavioral Ecological Model (BEM), this study will assess factors that influence&#xD;
      parent's willingness to participate in tobacco trials that emphasize cessation or promotion&#xD;
      of smoke-free homes/cars while identifying barriers for implementing these strategies.&#xD;
      Information will be obtained from questionnaires completed by parents. This information will&#xD;
      be used to suggest an appropriate emphasis for intervention, refine our recruitment&#xD;
      strategies, design interventions that maximize participation rates and retention, and better&#xD;
      direct our resources and future tobacco control efforts for patients and their families.&#xD;
&#xD;
      PRIMARY OBJECTIVE:&#xD;
&#xD;
        -  To estimate the proportion of smoking parents of children with cancer, children with&#xD;
           sickle cell disease (SCD), and childhood cancer survivors who are willing to participate&#xD;
           in tobacco trials offered in the context of their child's medical care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Proportion of parents willing to participate in tobacco trials</measure>
    <time_frame>Once, at enrollment</time_frame>
    <description>The proportion of parents who are willing to participate in a tobacco trial will be determined by affirmative responses to at least one of three questions that assess willingness to participate in a research study focused on smoking cessation, adoption of a smoke-free home and car, and/or enforcement and maintenance of a smoke-free home and car.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">88</enrollment>
  <condition>Smoking</condition>
  <condition>Cancer</condition>
  <condition>Sickle Cell Disease</condition>
  <arm_group>
    <arm_group_label>Cancer</arm_group_label>
    <description>Parents of children with cancer will complete a questionnaire.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sickle cell disease</arm_group_label>
    <description>Parents of children with sickle cell disease will complete a questionnaire.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Survivors</arm_group_label>
    <description>Parents of survivors of childhood cancer will complete a questionnaire.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Questionnaire data will be collected one time from parents who enroll on the study during their child's regular clinical visit. We will use a cross-sectional design to estimate the proportion of smoking parents of children with or surviving cancer, or sickle cell disease (SCD) who are willing to participate in tobacco trials, hypothetically offered in the context of their child's medical care. We will also examine the contribution of sociodemographic, environmental, and psychosocial variables, as well as, smoking behaviors as they relate to a parent's willingness to participate in a tobacco-related study.</description>
    <arm_group_label>Cancer</arm_group_label>
    <arm_group_label>Sickle cell disease</arm_group_label>
    <arm_group_label>Survivors</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        For the purposes of this protocol, the term &quot;parent&quot; includes biological parents,&#xD;
        step-parents, and legal guardians.&#xD;
&#xD;
        The primary study population will consist of parents of St. Jude Children's Research&#xD;
        Hospital (SJCRH) patients with a diagnosis of (1) cancer or (2) sickle cell disease (to&#xD;
        include genotypes HbSS, HbSC, HbSβ°thal, HbSβ+thal, HbSD, HbSO, Hb S/HPFH, HbSE), or (3)&#xD;
        will be a surviving cancer patient.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        CHILD INCLUSION CRITERIA:&#xD;
&#xD;
          -  SJCRH patient with a diagnosis of cancer or sickle cell disease (to include genotypes&#xD;
             HbSS, HbSC, HbSβ°thal, HbSβ+thal, HbSD, HbSO, Hb S/HPFH, HbSE).&#xD;
&#xD;
          -  &lt;18 years of age at time of enrollment.&#xD;
&#xD;
          -  For patients with cancer, those who are at least one month from diagnosis (to include&#xD;
             patients in active treatment section, as well as, survivors in After Completion of&#xD;
             Therapy clinic).&#xD;
&#xD;
        CHILD EXCLUSION CRITERIA:&#xD;
&#xD;
          -  For patients with cancer, those who have relapsed or had disease recurrence within the&#xD;
             past month.&#xD;
&#xD;
          -  For patients with cancer, those who have progressive disease.&#xD;
&#xD;
          -  In medical crisis, as determined by consultation with the patient's primary care&#xD;
             physician.&#xD;
&#xD;
          -  On transplant service.&#xD;
&#xD;
          -  On inpatient service or expected/scheduled inpatient admission (e.g. hospitalized).&#xD;
&#xD;
          -  Experiencing current acute complications of sickle cell disease requiring&#xD;
             hospitalization or an acute care visit (e.g., pain crises, acute chest syndrome, acute&#xD;
             cerebrovascular events/stroke or active infection/fever, etc.).&#xD;
&#xD;
        PARENT INCLUSION CRITERIA:&#xD;
&#xD;
          -  One parent, who is 18 years of age or older, per family of a SJCRH patient who meets&#xD;
             criteria.&#xD;
&#xD;
          -  Current smoker (defined as having smoked cigarettes in the past 30 days, as based on&#xD;
             self-report.)&#xD;
&#xD;
          -  Reads and speaks English.&#xD;
&#xD;
          -  Has the cognitive capacity to complete study questionnaires.&#xD;
&#xD;
          -  Willing and able to provide informed consent according to institutional guidelines.&#xD;
&#xD;
        PARENT EXCLUSION CRITERIA:&#xD;
&#xD;
          -  In crisis or distress or have another disabling condition that would preclude&#xD;
             participation as determined by consultation with patient's primary care physician&#xD;
             and/or social worker prior to study enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Klosky, 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>March 2015</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>March 4, 2015</last_update_submitted>
  <last_update_submitted_qc>March 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 5, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Smoking cessation</keyword>
  <keyword>Household smoking bans</keyword>
  <keyword>Cancer</keyword>
  <keyword>Sickle cell disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Sickle Cell</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/NCT01673243
org study id: XPD12-110 SMOBAN
nct id: NCT01673243
lead sponsor: 
has dmc: No
Little is known about what factors influence parental decisions to participate or to decline
      participation in tobacco trials offered in the pediatric clinical setting. Further, it is
      unclear what proportion of parents treated in our setting would elect to receive formal
      assistance with quitting smoking or consider alternative approaches that could facilitate
      eventual smoking cessation. While the recommendation to parents is generally to quit smoking,
      some may be unwilling or unable to quit and prefer more achievable alternative treatment
      goals. Some parent smokers may be unlikely to participate in an intervention aimed only at
      cessation but would be willing to participate in an intervention focused on establishing
      smoke-free environments for their child. Parents are typically not offered a choice regarding
      the type of intervention they receive and many interventions are not tailored to their
      readiness to quit smoking or designed to reach multiple family members in the home who may
      also smoke. Quitting smoking and establishing smoke-free homes and cars are distinct, yet
      challenging, goals for parents and families. Both approaches can directly, or indirectly,
      help parents to quit smoking, reduce the child's exposure to second-hand smoke (SHS), and
      initiate an important dialogue with families about tobacco control. How parental
      acceptability of smoking interventions is affected by the context of their child's treatment
      for cancer or SCD, as well as survivorship, warrants further study.
Following a Behavioral Ecological Model (BEM), this study will assess factors that influence
      parent's willingness to participate in tobacco trials that emphasize cessation or promotion
      of smoke-free homes/cars while identifying barriers for implementing these strategies.
      Information will be obtained from questionnaires completed by parents. This information will
      be used to suggest an appropriate emphasis for intervention, refine our recruitment
      strategies, design interventions that maximize participation rates and retention, and better
      direct our resources and future tobacco control efforts for patients and their families.

      PRIMARY OBJECTIVE:

        -  To estimate the proportion of smoking parents of children with cancer, children with
           sickle cell disease (SCD), and childhood cancer survivors who are willing to participate
           in tobacco trials offered in the context of their child's medical care.
observational model: Cohort
time perspective: Prospective
measure: Proportion of parents willing to participate in tobacco trials
time frame: Once, at enrollment
description: The proportion of parents who are willing to participate in a tobacco trial will be determined by affirmative responses to at least one of three questions that assess willingness to participate in a research study focused on smoking cessation, adoption of a smoke-free home and car, and/or enforcement and maintenance of a smoke-free home and car.
arm group label: Cancer
description: Parents of children with cancer will complete a questionnaire.
arm group label: Sickle cell disease
description: Parents of children with sickle cell disease will complete a questionnaire.
arm group label: Survivors
description: Parents of survivors of childhood cancer will complete a questionnaire.
intervention type: Other
intervention name: Questionnaire
description: Questionnaire data will be collected one time from parents who enroll on the study during their child's regular clinical visit. We will use a cross-sectional design to estimate the proportion of smoking parents of children with or surviving cancer, or sickle cell disease (SCD) who are willing to participate in tobacco trials, hypothetically offered in the context of their child's medical care. We will also examine the contribution of sociodemographic, environmental, and psychosocial variables, as well as, smoking behaviors as they relate to a parent's willingness to participate in a tobacco-related study.
arm group label: Cancer
arm group label: Sickle cell disease
arm group label: Survivors
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: James Klosky, 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: Anemia, Sickle Cell