<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/NCT03281161</url>
  </required_header>
  <id_info>
    <org_study_id>5R01CA187191-02</org_study_id>
    <secondary_id>5R01CA187191-02</secondary_id>
    <secondary_id>0284</secondary_id>
    <nct_id>NCT03281161</nct_id>
  </id_info>
  <brief_title>Sun Safe Workplaces: Assessment of Benefits and Costs of a Policy Intervention</brief_title>
  <acronym>SSW2</acronym>
  <official_title>Sun Safe Workplaces: Assessment of Benefits and Costs of a Policy Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Klein Buendel, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kaiser Foundation Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Klein Buendel, Inc.</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>
      Sun Safe Workplaces (SSW), a comprehensive occupational sun safety program, promoted&#xD;
      education and policy to 98 cities, counties, and special districts in Colorado. In a two-year&#xD;
      follow-up study, Klein Buendel, Inc. (KB) proposes to examine the effectiveness of SSW on&#xD;
      employee sun protection practices by employers and return on investment in an economic&#xD;
      evaluation of the cost of the SSW intervention. The results of this follow-up study will&#xD;
      provide critical information on effective approaches to increasing sun protection across a&#xD;
      wide range of employment sectors with outdoor workers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Workers in the United States spend large amounts of time on the job, making the workplace a&#xD;
      key venue for preventive health programs. A workplace risk that has received limited&#xD;
      attention is solar ultraviolet radiation (UVR). Unprotected exposure to solar UVR of outdoor&#xD;
      workers can produce both an immediate acute harm (i.e., severe sunburn) and long-term skin&#xD;
      damage that can elevate the risk of developing skin cancers. Preventing skin cancer is a&#xD;
      priority due to its high prevalence; tendency to recur; association with other cancers; and&#xD;
      lost productivity ($66.9 billion in losses were attributed to melanoma-related mortality from&#xD;
      1990-2008). Sun Safe Workplaces (SSW) is a comprehensive occupational sun safety education&#xD;
      and policy intervention that was tested by Klein Buendel, Inc.'s (KB) research team in a&#xD;
      randomized control trial with 98 cities, counties, and special districts in Colorado.&#xD;
      Posttesting was completed in November 2013. The SSW intervention focused on three sectors in&#xD;
      the organizations: public works, public safety, and parks and recreation. Half of the&#xD;
      employers received the SSW intervention, with the remaining employers in the control&#xD;
      condition receiving basic sun safety information. Preliminary analyses indicate that 80% of&#xD;
      employers in the SSW intervention condition provided sun safety education to employees and&#xD;
      36% adopted formal sun protection policies. No control organizations reported policy&#xD;
      adoption. KB will conduct a two-year follow-up study on the benefits of the SSW intervention&#xD;
      (i.e., increasing employees' sun protection) and return on investment (ROI; benefits relative&#xD;
      to intervention costs). Employee behavior was not assessed in the current SSW trial because&#xD;
      it was uncertain whether the SSW intervention would result in uptake of education and policy&#xD;
      and thus have the potential to influence their sun protection practices. The proposed&#xD;
      two-year follow-up of the 98 organizations in the SSW trial will include: (1) surveys with&#xD;
      employees (n=10,787) and front line supervisors (n=767) to assess employees' sun protection&#xD;
      practices and workplace actions to support employee sun safety; (2) on-site observations of&#xD;
      sun protection actions by the employers (e.g., posters, sunscreen, shade structures); and (3)&#xD;
      tracking of the costs of implementing the SSW intervention and induced employer costs. The&#xD;
      proposed analyses will compare the sun protection practices of employees a) between&#xD;
      workplaces that received the SSW intervention and controls and b) among workplaces that&#xD;
      provided education and adopted policy, provided education only, and control workplaces.&#xD;
      Analyses will determine if the extent of sun protection actions by employers influences&#xD;
      employees' sun safety practices. The economic evaluation will estimate the ROI (i.e.,&#xD;
      comparison of the estimated program benefits to combined cost elements). The proposed study&#xD;
      is significant and innovative because it provides critical information applicable to a wide&#xD;
      range of industrial sectors with outdoor workers on a workplace risk that has received scant&#xD;
      attention. Determining the effectiveness and ROI of prevention programs is essential for&#xD;
      national and local resource investment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 27, 2015</start_date>
  <completion_date type="Actual">July 31, 2017</completion_date>
  <primary_completion_date type="Actual">April 30, 2017</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants were not aware of the condition in which their organization was enrolled.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Survey of sun protection practices by employees.</measure>
    <time_frame>9 Months</time_frame>
    <description>Quantitative research in the form of a posttest survey was conducted to examine the sun safety practices by employees among workplaces that received education but did not adopt written policies, those workplaces that received education and adopted written policies and those that were in the control group.safety practices by employees among workplaces that received education but did not adopt written policies.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Observational checklist to review sun protections items within the workplace.</measure>
    <time_frame>9 months</time_frame>
    <description>An observational visit checklist was used to review sun protection items within the environment to assess employer actions to improve worker sun safety in the SSW parent study project. This checklist accounted for program materials (posters, tip cards, brochures, policy tool box items) and other sun safety protective items such as sunscreen and portable and permanent shade provided by the workplace for employees.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-depth manager interview to assess relationship of employer sun safety actions to employee sun safety.</measure>
    <time_frame>9 Months</time_frame>
    <description>Analysis of the association of employer actions (education only vs. education plus policy) on sun safety with employee's sun protection practices.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-depth manager survey to assess relationship of employer sun safety actions to employee sun safety.</measure>
    <time_frame>9 Months</time_frame>
    <description>Analysis of the association of employer actions (education only vs. education plus policy) on sun safety with employee's sun protection practices.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extraction of costs from parent study ledgers to conduct economic analysis of the SSW intervention.</measure>
    <time_frame>9 Months</time_frame>
    <description>Cost information from the SSW parent study project ledgers was extracted for the economic evaluation of the benefits and costs of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-depth manager interview to conduct economic analysis of the SSW intervention.</measure>
    <time_frame>9 Months</time_frame>
    <description>An In-depth manger interview was conducted with managers to determine what sun safety items and practices the worksite was doing before and after the program and the costs associated with those practices.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of employee surveys to compare the impact of workplaces implementing education-only versus education plus policy adoption on employee sun safety practices.</measure>
    <time_frame>9 Months</time_frame>
    <description>To compare the actions of intervention employers implementing education, intervention employers implementing education and adopting policy on employee sun safety.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1990</enrollment>
  <condition>Skin Cancer</condition>
  <arm_group>
    <arm_group_label>Sun Safe Workplaces Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A follow up to the previous study that promoted the adoption of occupational sun protection policies by the local government organization comprised of personal visits with senior managers to promote policy adoption, promotional materials for sun safety, and in-person training of outdoor workers by research staff over two years. The follow up program consists of an analysis of sun safe practices by employees and an economic evaluation of the SSW intervention completed 2 years after the initial intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A follow up to the previous study that promoted occupational sun protection practices by employees in local government organizations through two mailings containing educational materials and presentations at state professional meetings by project staff. The follow up program consists of an analysis of sun safe practices by employees and an economic evaluation of SSW completed 2 years after the initial program contact.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sun Safe Workplaces Program</intervention_name>
    <description>A follow-up analysis of sun safe practices by employees and an economic evaluation of the SSW intervention was conducted with the work-sites who received occupational sun protection policy promotion materials in the prior trial. The analysis of sun safety practices of employees was done by preparing the protocols and measures for surveying employees and front-line supervisors by online and paper methods. The economic evaluation was a retrospective collection of cost information from the prior project ledgers and an in depth interview with the key contact manager at each work-site. No additional treatment was provided and the groups were evaluated based on their prior condition assignment.</description>
    <arm_group_label>Sun Safe Workplaces Program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Attention Control</intervention_name>
    <description>A follow-up analysis of sun safe practices by employees and an economic evaluation of the SSW intervention was conducted with the work-sites who received occupational sun protection practice promotion materials in the prior trial. The analysis of sun safety practices of employees was done by preparing the protocols and measures for surveying employees and front-line supervisors by online and paper methods. The economic evaluation was a retrospective collection of cost information from the prior project ledgers and an in depth interview with the key contact manager at each work-site. No additional treatment was provided and the groups were evaluated based on their prior condition assignment.</description>
    <arm_group_label>Attention Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participation in the prior Sun Safe Workplaces: A Campaign on Sun Protection Policies&#xD;
             for Outdoor Workers.&#xD;
&#xD;
          -  A local government organization with employees who worked outdoors in at least one of&#xD;
             the following service areas: public works, public safety, and parks and recreation,&#xD;
&#xD;
          -  Having a full time executive&#xD;
&#xD;
          -  Having a population of at least 3000 residents&#xD;
&#xD;
          -  Being employed at a participating local government organization as a manager or&#xD;
             employee?&#xD;
&#xD;
          -  Being employed at a participating local government organization in a job requiring&#xD;
             outdoor work at least part of the time.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Organization had participated in the authors' previous occupational sun protection&#xD;
             project.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Buller, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klein Buendel, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaiser Foundation Research Institute</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94612-3466</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Denver</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045-0508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>skin cancer</keyword>
  <keyword>prevention</keyword>
  <keyword>worksite</keyword>
  <keyword>policy</keyword>
  <keyword>cost and effectiveness</keyword>
  <keyword>implementation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin 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>


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/NCT03281161
org study id: 5R01CA187191-02
secondary id: 5R01CA187191-02
secondary id: 0284
nct id: NCT03281161
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sun Safe Workplaces (SSW), a comprehensive occupational sun safety program, promoted
      education and policy to 98 cities, counties, and special districts in Colorado. In a two-year
      follow-up study, Klein Buendel, Inc. (KB) proposes to examine the effectiveness of SSW on
      employee sun protection practices by employers and return on investment in an economic
      evaluation of the cost of the SSW intervention. The results of this follow-up study will
      provide critical information on effective approaches to increasing sun protection across a
      wide range of employment sectors with outdoor workers.
Workers in the United States spend large amounts of time on the job, making the workplace a
      key venue for preventive health programs. A workplace risk that has received limited
      attention is solar ultraviolet radiation (UVR). Unprotected exposure to solar UVR of outdoor
      workers can produce both an immediate acute harm (i.e., severe sunburn) and long-term skin
      damage that can elevate the risk of developing skin cancers. Preventing skin cancer is a
      priority due to its high prevalence; tendency to recur; association with other cancers; and
      lost productivity ($66.9 billion in losses were attributed to melanoma-related mortality from
      1990-2008). Sun Safe Workplaces (SSW) is a comprehensive occupational sun safety education
      and policy intervention that was tested by Klein Buendel, Inc.'s (KB) research team in a
      randomized control trial with 98 cities, counties, and special districts in Colorado.
      Posttesting was completed in November 2013. The SSW intervention focused on three sectors in
      the organizations: public works, public safety, and parks and recreation. Half of the
      employers received the SSW intervention, with the remaining employers in the control
      condition receiving basic sun safety information. Preliminary analyses indicate that 80% of
      employers in the SSW intervention condition provided sun safety education to employees and
      36% adopted formal sun protection policies. No control organizations reported policy
      adoption. KB will conduct a two-year follow-up study on the benefits of the SSW intervention
      (i.e., increasing employees' sun protection) and return on investment (ROI; benefits relative
      to intervention costs). Employee behavior was not assessed in the current SSW trial because
      it was uncertain whether the SSW intervention would result in uptake of education and policy
      and thus have the potential to influence their sun protection practices. The proposed
      two-year follow-up of the 98 organizations in the SSW trial will include: (1) surveys with
      employees (n=10,787) and front line supervisors (n=767) to assess employees' sun protection
      practices and workplace actions to support employee sun safety; (2) on-site observations of
      sun protection actions by the employers (e.g., posters, sunscreen, shade structures); and (3)
      tracking of the costs of implementing the SSW intervention and induced employer costs. The
      proposed analyses will compare the sun protection practices of employees a) between
      workplaces that received the SSW intervention and controls and b) among workplaces that
      provided education and adopted policy, provided education only, and control workplaces.
      Analyses will determine if the extent of sun protection actions by employers influences
      employees' sun safety practices. The economic evaluation will estimate the ROI (i.e.,
      comparison of the estimated program benefits to combined cost elements). The proposed study
      is significant and innovative because it provides critical information applicable to a wide
      range of industrial sectors with outdoor workers on a workplace risk that has received scant
      attention. Determining the effectiveness and ROI of prevention programs is essential for
      national and local resource investment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
masking description: Participants were not aware of the condition in which their organization was enrolled.
measure: Survey of sun protection practices by employees.
time frame: 9 Months
description: Quantitative research in the form of a posttest survey was conducted to examine the sun safety practices by employees among workplaces that received education but did not adopt written policies, those workplaces that received education and adopted written policies and those that were in the control group.safety practices by employees among workplaces that received education but did not adopt written policies.
measure: Observational checklist to review sun protections items within the workplace.
time frame: 9 months
description: An observational visit checklist was used to review sun protection items within the environment to assess employer actions to improve worker sun safety in the SSW parent study project. This checklist accounted for program materials (posters, tip cards, brochures, policy tool box items) and other sun safety protective items such as sunscreen and portable and permanent shade provided by the workplace for employees.
measure: In-depth manager interview to assess relationship of employer sun safety actions to employee sun safety.
time frame: 9 Months
description: Analysis of the association of employer actions (education only vs. education plus policy) on sun safety with employee's sun protection practices.
measure: In-depth manager survey to assess relationship of employer sun safety actions to employee sun safety.
time frame: 9 Months
description: Analysis of the association of employer actions (education only vs. education plus policy) on sun safety with employee's sun protection practices.
measure: Extraction of costs from parent study ledgers to conduct economic analysis of the SSW intervention.
time frame: 9 Months
description: Cost information from the SSW parent study project ledgers was extracted for the economic evaluation of the benefits and costs of the intervention.
measure: In-depth manager interview to conduct economic analysis of the SSW intervention.
time frame: 9 Months
description: An In-depth manger interview was conducted with managers to determine what sun safety items and practices the worksite was doing before and after the program and the costs associated with those practices.
measure: Analysis of employee surveys to compare the impact of workplaces implementing education-only versus education plus policy adoption on employee sun safety practices.
time frame: 9 Months
description: To compare the actions of intervention employers implementing education, intervention employers implementing education and adopting policy on employee sun safety.
arm group label: Sun Safe Workplaces Program
arm group type: Experimental
description: A follow up to the previous study that promoted the adoption of occupational sun protection policies by the local government organization comprised of personal visits with senior managers to promote policy adoption, promotional materials for sun safety, and in-person training of outdoor workers by research staff over two years. The follow up program consists of an analysis of sun safe practices by employees and an economic evaluation of the SSW intervention completed 2 years after the initial intervention.
arm group label: Attention Control
arm group type: Active Comparator
description: A follow up to the previous study that promoted occupational sun protection practices by employees in local government organizations through two mailings containing educational materials and presentations at state professional meetings by project staff. The follow up program consists of an analysis of sun safe practices by employees and an economic evaluation of SSW completed 2 years after the initial program contact.
intervention type: Behavioral
intervention name: Sun Safe Workplaces Program
description: A follow-up analysis of sun safe practices by employees and an economic evaluation of the SSW intervention was conducted with the work-sites who received occupational sun protection policy promotion materials in the prior trial. The analysis of sun safety practices of employees was done by preparing the protocols and measures for surveying employees and front-line supervisors by online and paper methods. The economic evaluation was a retrospective collection of cost information from the prior project ledgers and an in depth interview with the key contact manager at each work-site. No additional treatment was provided and the groups were evaluated based on their prior condition assignment.
arm group label: Sun Safe Workplaces Program
intervention type: Behavioral
intervention name: Attention Control
description: A follow-up analysis of sun safe practices by employees and an economic evaluation of the SSW intervention was conducted with the work-sites who received occupational sun protection practice promotion materials in the prior trial. The analysis of sun safety practices of employees was done by preparing the protocols and measures for surveying employees and front-line supervisors by online and paper methods. The economic evaluation was a retrospective collection of cost information from the prior project ledgers and an in depth interview with the key contact manager at each work-site. No additional treatment was provided and the groups were evaluated based on their prior condition assignment.
arm group label: Attention Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David Buller, PhD
role: Principal Investigator
affiliation: Klein Buendel, Inc.
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Skin Neoplasms
sharing ipd: No