<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/NCT03278340</url>
  </required_header>
  <id_info>
    <org_study_id>0316</org_study_id>
    <secondary_id>0316</secondary_id>
    <secondary_id>R01CA210259</secondary_id>
    <nct_id>NCT03278340</nct_id>
  </id_info>
  <brief_title>Using Technology to Scale-Up an Occupational Sun Protection Policy Program</brief_title>
  <acronym>SSW-T</acronym>
  <official_title>Using Technology to Scale-Up an Occupational Sun Protection Policy Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Klein Buendel, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</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>
      Comprehensive approaches that combine sun protection policy and education for outdoor workers&#xD;
      can reduce their risk for skin cancer by reducing their exposure to solar ultraviolet&#xD;
      radiation on the job. To effectively disseminate the investigators' evidence-based sun&#xD;
      protection policy and education intervention, Sun Safe Workplaces, a balance of effectiveness&#xD;
      and cost of scale-up methods is required. The investigators propose to translate the&#xD;
      intervention using a technology-based delivery method and compare the cost effectiveness of&#xD;
      the original intervention and the intervention delivered by technology in a study that models&#xD;
      national distribution strategies to public safety and public works sectors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A key goal in the Affordable Care Act is building a national culture of prevention through&#xD;
      workplace health and safety initiatives. To achieve this goal, methods for scaling up&#xD;
      evidence-based programs from research to wide-scale dissemination are needed to help balance&#xD;
      effectiveness and cost. In many cases, there are pressures to reduce scale-up costs but at&#xD;
      the expense of lower program implementation and effectiveness. A scale-up method that&#xD;
      sacrifices effectiveness but reduces costs and reaches a larger number of employers may be&#xD;
      acceptable. The investigators will model the effectiveness and cost trade-off, along with the&#xD;
      extent and representativeness of reach, when scaling up the evidence-based occupational sun&#xD;
      protection intervention, Sun Safe Workplaces (SSW), for national distribution. The&#xD;
      intervention, which relies on personal contact with managers and in-person employee training&#xD;
      (SSW-IP), created large improvements in comprehensive workplace sun safety (i.e., policy&#xD;
      adoption and employee education) in a randomized controlled trial. The investigators will&#xD;
      compare the existing in-person program delivery methods (SSW-IP) to a lower-cost&#xD;
      dissemination method that utilizes Internet technology (SSW-T), i.e., virtual meetings,&#xD;
      social networking, online training, and program materials. The aims of the research are to:&#xD;
      1) estimate the program reach (number and representativeness) and implementation rates (i.e.,&#xD;
      adoption of policies and delivery of education on occupational sun protection) achieved by&#xD;
      the SSW-IP and SSW-T in a model of national distribution to public safety and public works&#xD;
      industries; 2) estimate the costs associated with the SSW-IP and SSW-T (i.e., intervention&#xD;
      costs and induced employer costs) and compare the estimated program benefits (i.e., policy&#xD;
      and education) to cost; and 3) estimate the effect and cost-effectiveness of SSW-IP and SSW-T&#xD;
      in secondary outcomes of a) changes in workplace environments and procedures for sun safety&#xD;
      and b) workers' sun safety practices. In a 5-year project, SSW-T will be created by&#xD;
      redesigning the very effective SSW-IP methods to use the latest web conferencing, social&#xD;
      networking, and online training technology for dissemination. The implementation rates&#xD;
      (defined as policy adoption and education delivery) and costs associated with SSW-IP (n=50&#xD;
      employers) and SSW-T (n=150 employers) will be modeled in a randomized two-group&#xD;
      pretest-posttest design, enrolling a national sample of 200 employers (i.e., firefighting&#xD;
      departments and state departments of transportation). Unlike traditional randomized trials,&#xD;
      the primary analysis will be of cost effectiveness to test the hypothesis that SSW-T can be&#xD;
      delivered cost-effectively to an expanded group of worksites producing a lower implementation&#xD;
      rate than SSW-IP but at substantially lower cost. Secondary analyses will compare the two&#xD;
      scale-up strategies on implementation rate, differences in rate by employer groups (e.g.,&#xD;
      size and region), changes to workplace environment/procedures, and employee sun safety&#xD;
      practices. The findings will have high impact by helping public health practitioners select&#xD;
      the best strategy for scaling up evidence-based workplace health and safety programs to&#xD;
      achieve this ACA goal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">May 30, 2018</start_date>
  <completion_date type="Anticipated">July 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants will not be aware of the condition in which their organization is assigned.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Implementation of Occupational Sun Protection Policy</measure>
    <time_frame>Baseline to 2 years followup</time_frame>
    <description>Policies will be collected from work sites and coded at both before and after the intervention period. Project staff will code written workplace policy documents on the presence of 15 &quot;content categories&quot; in three domains: 1) environmental controls; 2) administrative procedures; and 3) personal protection practices. Presence of policy is defined as having one or more policy components present in the written workplace policy documents (value = 1) versus no content components present (value = 0).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Implementation of Sun Safety Education</measure>
    <time_frame>Baseline to 2 year followup</time_frame>
    <description>Senior managers and employees will report on sun safety education provided to employees. The primary measure will be managers' reports of any training or any sun safety messages/materials distributed (e.g., newsletter articles, SSW website, or emails). Employees' reports of sun safety education will be secondary, validating managers' reports. These measures will be obtained in senior manager and employee pretest and posttest surveys, conducted online and by mail</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Economic Evaluation of the SSW-IP and SSW-T Intervention Programs</measure>
    <time_frame>Baseline to 2 year followup</time_frame>
    <description>Project staff will record costs associated with the SSW-IP and SSW-T, following protocols from prior projects. Project staff will identify resource allocations and both labor and non labor elements for each component of the SSW-IP and SSW-T (in-person and virtual visits; follow-up communications; staff-delivered and virtual training, web resources, and mailed materials). For personnel, the proportion of FTE across activities will be estimated by contemporaneous staff self-report. Senior manager and employee survey data will identify organizational changes induced by SSW-IP and SSW-T and attach cost estimates to each. The investigators will use the accounting systems of the trial itself, supplemented with survey responses and additional primary data collection or external sources. Costs will be recorded in custom-made spreadsheets and summed to produce overall cost estimates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Workplace Environment for Sun Safety</measure>
    <time_frame>Baseline to 2 year followup</time_frame>
    <description>Managers will report changes in the work environments (providing shade and adjusting outdoor work schedules) or procedures (risk assessment, posting UV Index, and providing sunscreen, hats, protective clothing, and sunglasses) for sun safety. To validate, trained staff (blind to condition) will visit 18 randomly-selected employers at post-test and record shade, posting of UV Index, sunscreen availability, employee clothing, hats, and sunglasses, and educational materials, using a protocol from our Go Sun Smart trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other Policy-related Measures</measure>
    <time_frame>Baseline to 2 year followup</time_frame>
    <description>The investigators will measure two ancillary policy outcomes in the senior manager surveys, the content of informal procedures (not written) and enforcement of any sun protection policies (i.e., how well is policy being implemented and how well are staff complying with policy [very well, well, about average, poorly, or very poorly]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Employees Sun Protection Practices</measure>
    <time_frame>Baseline to 2 year followup</time_frame>
    <description>Employees will report a) frequency of sun protection at work, i.e., sunscreen with SPF 15+, long-sleeved shirts, long pants, hat with brim, sunglasses, shade use, limit exposure to midday sun, and have sunscreen, hat and eye protection at all times (1=never, 5=always) and b) prevalence of sunburn in the past three months on the job (yes/no; number of times) from SSW and GSS trials. These are standard, validated, and reliable measures from past studies.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">11394</enrollment>
  <condition>Skin Cancer</condition>
  <arm_group>
    <arm_group_label>Sun Safe Workplaces - Technology (SSW-T)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Program promoting the adoption of sun protection policies by fire departments and state Departments of Transportation that is delivered via a range of technology systems including web-enabled visits with senior managers, online training of outdoor workers, and online access to collateral materials (e.g., brochures, posters, tip cards).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sun Safe Workplaces - In Person (SSW-IP)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Program promoting the adoption of sun protection policies by fire departments and state Departments of Transportation that is delivered via personal visits with senior managers and in person training of outdoor workers by research staff over two years. Collateral materials (e.g., brochures, posters, tip cards) will be provided to worksites.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sun Safe Workplaces - Technology</intervention_name>
    <description>After randomization, program staff will contact managers at the recruited employer and schedule the initial web-enabled visit in the first 6 months. Follow-up meetings will be scheduled as needed to discuss policy adoption, and managers will schedule employee education using the SSW-T online training. Staff will follow-up with managers through Month 34 (Wave 1) or Month 46 (Wave 2). Electronic materials will be published on KB's state-of-the-art web server for employers to access and use.</description>
    <arm_group_label>Sun Safe Workplaces - Technology (SSW-T)</arm_group_label>
    <other_name>SSW-T</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sun Safe Workplaces -In Person</intervention_name>
    <description>After randomization, program staff will contact managers the recruited employer and schedule the initial in-person visit in the first 6 months. Follow-up meetings will be scheduled as needed to discuss policy adoption; managers will schedule employee education with SSW-IP project staff. Printed materials will be sent to SSW-IP employers 3 times during the intervention. Staff will follow-up with managers through Month 34 (Wave 1) or Month 46 (Wave 2).</description>
    <arm_group_label>Sun Safe Workplaces - In Person (SSW-IP)</arm_group_label>
    <other_name>SSW-IP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fire Departments and State DOTs in the United States, agreeing to participate,&#xD;
             providing written policies at pretest and having at least 6 managers and 50 workers&#xD;
             complete the pretest.&#xD;
&#xD;
          -  Being a senior manager of a fire department or state DOT located in the United States.&#xD;
             Criteria include a) being in a senior management position; b) responsible for&#xD;
             work-site safety/health policy and education; c) consenting to participate, and d)&#xD;
             completing the pretest. This includes city/county managers, human resources directors,&#xD;
             risk managers, and managers of facilities, fire, roads and transportation departments&#xD;
&#xD;
          -  Being an employee of a fire department or state DOT located in the United States.&#xD;
             Criteria includes a) being employed part/full-time at the employer, b) working at&#xD;
             least part of daytime hours outdoors, c) consenting to participate, and d) completing&#xD;
             the pretest survey.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior participation in the Sun Safe Workplaces program&#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>Klein Buendel, Inc.</name>
      <address>
        <city>Golden</city>
        <state>Colorado</state>
        <zip>80403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>October 18, 2022</last_update_submitted>
  <last_update_submitted_qc>October 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Skin Cancer</keyword>
  <keyword>Prevention</keyword>
  <keyword>Policy</keyword>
  <keyword>Worksite</keyword>
  <keyword>Scale-up</keyword>
  <keyword>Cost and Effectiveness</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/NCT03278340
org study id: 0316
secondary id: 0316
secondary id: R01CA210259
nct id: NCT03278340
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Comprehensive approaches that combine sun protection policy and education for outdoor workers
      can reduce their risk for skin cancer by reducing their exposure to solar ultraviolet
      radiation on the job. To effectively disseminate the investigators' evidence-based sun
      protection policy and education intervention, Sun Safe Workplaces, a balance of effectiveness
      and cost of scale-up methods is required. The investigators propose to translate the
      intervention using a technology-based delivery method and compare the cost effectiveness of
      the original intervention and the intervention delivered by technology in a study that models
      national distribution strategies to public safety and public works sectors.
A key goal in the Affordable Care Act is building a national culture of prevention through
      workplace health and safety initiatives. To achieve this goal, methods for scaling up
      evidence-based programs from research to wide-scale dissemination are needed to help balance
      effectiveness and cost. In many cases, there are pressures to reduce scale-up costs but at
      the expense of lower program implementation and effectiveness. A scale-up method that
      sacrifices effectiveness but reduces costs and reaches a larger number of employers may be
      acceptable. The investigators will model the effectiveness and cost trade-off, along with the
      extent and representativeness of reach, when scaling up the evidence-based occupational sun
      protection intervention, Sun Safe Workplaces (SSW), for national distribution. The
      intervention, which relies on personal contact with managers and in-person employee training
      (SSW-IP), created large improvements in comprehensive workplace sun safety (i.e., policy
      adoption and employee education) in a randomized controlled trial. The investigators will
      compare the existing in-person program delivery methods (SSW-IP) to a lower-cost
      dissemination method that utilizes Internet technology (SSW-T), i.e., virtual meetings,
      social networking, online training, and program materials. The aims of the research are to:
      1) estimate the program reach (number and representativeness) and implementation rates (i.e.,
      adoption of policies and delivery of education on occupational sun protection) achieved by
      the SSW-IP and SSW-T in a model of national distribution to public safety and public works
      industries; 2) estimate the costs associated with the SSW-IP and SSW-T (i.e., intervention
      costs and induced employer costs) and compare the estimated program benefits (i.e., policy
      and education) to cost; and 3) estimate the effect and cost-effectiveness of SSW-IP and SSW-T
      in secondary outcomes of a) changes in workplace environments and procedures for sun safety
      and b) workers' sun safety practices. In a 5-year project, SSW-T will be created by
      redesigning the very effective SSW-IP methods to use the latest web conferencing, social
      networking, and online training technology for dissemination. The implementation rates
      (defined as policy adoption and education delivery) and costs associated with SSW-IP (n=50
      employers) and SSW-T (n=150 employers) will be modeled in a randomized two-group
      pretest-posttest design, enrolling a national sample of 200 employers (i.e., firefighting
      departments and state departments of transportation). Unlike traditional randomized trials,
      the primary analysis will be of cost effectiveness to test the hypothesis that SSW-T can be
      delivered cost-effectively to an expanded group of worksites producing a lower implementation
      rate than SSW-IP but at substantially lower cost. Secondary analyses will compare the two
      scale-up strategies on implementation rate, differences in rate by employer groups (e.g.,
      size and region), changes to workplace environment/procedures, and employee sun safety
      practices. The findings will have high impact by helping public health practitioners select
      the best strategy for scaling up evidence-based workplace health and safety programs to
      achieve this ACA goal.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
masking description: Participants will not be aware of the condition in which their organization is assigned.
measure: Implementation of Occupational Sun Protection Policy
time frame: Baseline to 2 years followup
description: Policies will be collected from work sites and coded at both before and after the intervention period. Project staff will code written workplace policy documents on the presence of 15 "content categories" in three domains: 1) environmental controls; 2) administrative procedures; and 3) personal protection practices. Presence of policy is defined as having one or more policy components present in the written workplace policy documents (value = 1) versus no content components present (value = 0).
measure: Implementation of Sun Safety Education
time frame: Baseline to 2 year followup
description: Senior managers and employees will report on sun safety education provided to employees. The primary measure will be managers' reports of any training or any sun safety messages/materials distributed (e.g., newsletter articles, SSW website, or emails). Employees' reports of sun safety education will be secondary, validating managers' reports. These measures will be obtained in senior manager and employee pretest and posttest surveys, conducted online and by mail
measure: Economic Evaluation of the SSW-IP and SSW-T Intervention Programs
time frame: Baseline to 2 year followup
description: Project staff will record costs associated with the SSW-IP and SSW-T, following protocols from prior projects. Project staff will identify resource allocations and both labor and non labor elements for each component of the SSW-IP and SSW-T (in-person and virtual visits; follow-up communications; staff-delivered and virtual training, web resources, and mailed materials). For personnel, the proportion of FTE across activities will be estimated by contemporaneous staff self-report. Senior manager and employee survey data will identify organizational changes induced by SSW-IP and SSW-T and attach cost estimates to each. The investigators will use the accounting systems of the trial itself, supplemented with survey responses and additional primary data collection or external sources. Costs will be recorded in custom-made spreadsheets and summed to produce overall cost estimates.
measure: Changes in Workplace Environment for Sun Safety
time frame: Baseline to 2 year followup
description: Managers will report changes in the work environments (providing shade and adjusting outdoor work schedules) or procedures (risk assessment, posting UV Index, and providing sunscreen, hats, protective clothing, and sunglasses) for sun safety. To validate, trained staff (blind to condition) will visit 18 randomly-selected employers at post-test and record shade, posting of UV Index, sunscreen availability, employee clothing, hats, and sunglasses, and educational materials, using a protocol from our Go Sun Smart trial.
measure: Other Policy-related Measures
time frame: Baseline to 2 year followup
description: The investigators will measure two ancillary policy outcomes in the senior manager surveys, the content of informal procedures (not written) and enforcement of any sun protection policies (i.e., how well is policy being implemented and how well are staff complying with policy [very well, well, about average, poorly, or very poorly]).
measure: Employees Sun Protection Practices
time frame: Baseline to 2 year followup
description: Employees will report a) frequency of sun protection at work, i.e., sunscreen with SPF 15+, long-sleeved shirts, long pants, hat with brim, sunglasses, shade use, limit exposure to midday sun, and have sunscreen, hat and eye protection at all times (1=never, 5=always) and b) prevalence of sunburn in the past three months on the job (yes/no; number of times) from SSW and GSS trials. These are standard, validated, and reliable measures from past studies.
arm group label: Sun Safe Workplaces - Technology (SSW-T)
arm group type: Experimental
description: Program promoting the adoption of sun protection policies by fire departments and state Departments of Transportation that is delivered via a range of technology systems including web-enabled visits with senior managers, online training of outdoor workers, and online access to collateral materials (e.g., brochures, posters, tip cards).
arm group label: Sun Safe Workplaces - In Person (SSW-IP)
arm group type: Active Comparator
description: Program promoting the adoption of sun protection policies by fire departments and state Departments of Transportation that is delivered via personal visits with senior managers and in person training of outdoor workers by research staff over two years. Collateral materials (e.g., brochures, posters, tip cards) will be provided to worksites.
intervention type: Behavioral
intervention name: Sun Safe Workplaces - Technology
description: After randomization, program staff will contact managers at the recruited employer and schedule the initial web-enabled visit in the first 6 months. Follow-up meetings will be scheduled as needed to discuss policy adoption, and managers will schedule employee education using the SSW-T online training. Staff will follow-up with managers through Month 34 (Wave 1) or Month 46 (Wave 2). Electronic materials will be published on KB's state-of-the-art web server for employers to access and use.
arm group label: Sun Safe Workplaces - Technology (SSW-T)
other name: SSW-T
intervention type: Behavioral
intervention name: Sun Safe Workplaces -In Person
description: After randomization, program staff will contact managers the recruited employer and schedule the initial in-person visit in the first 6 months. Follow-up meetings will be scheduled as needed to discuss policy adoption; managers will schedule employee education with SSW-IP project staff. Printed materials will be sent to SSW-IP employers 3 times during the intervention. Staff will follow-up with managers through Month 34 (Wave 1) or Month 46 (Wave 2).
arm group label: Sun Safe Workplaces - In Person (SSW-IP)
other name: SSW-IP
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