Sun Safe Workplaces: Assessment of Benefits and Costs of a Policy Intervention (SSW2)
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ClinicalTrials.gov Identifier: NCT03281161 |
Recruitment Status :
Completed
First Posted : September 13, 2017
Last Update Posted : October 26, 2017
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Sponsor:
Klein Buendel, Inc.
Collaborators:
National Cancer Institute (NCI)
Kaiser Foundation Research Institute
University of Colorado, Denver
Information provided by (Responsible Party):
Klein Buendel, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | September 6, 2017 | ||||
First Posted Date ICMJE | September 13, 2017 | ||||
Last Update Posted Date | October 26, 2017 | ||||
Actual Study Start Date ICMJE | February 27, 2015 | ||||
Actual Primary Completion Date | April 30, 2017 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Survey of sun protection practices by employees. [ Time Frame: 9 Months ] 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.
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Original Primary Outcome Measures ICMJE |
Employees at employers receiving SSW intervention will report more sun safety practices than controls. [ Time Frame: 9 months ] Employees who work outdoors reported their frequency of taking the following actions to protect their skin from the sun (1=Never, 2 = Rarely, 3 = Sometimes, 4 = Often, 5 = Always): apply sunscreen with sun protection factor (SPF) of 15 or more, wear clothing specifically to protect their skin from the sun such as long-sleeved shirts and pants, wear a hat with a brim, wear a hat with a wide-brim, wear sunglasses, limit exposure to the sun during midday hours, and stay mostly in the shade. The frequency rating are averaged to form a composite sun protection score.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Sun Safe Workplaces: Assessment of Benefits and Costs of a Policy Intervention | ||||
Official Title ICMJE | Sun Safe Workplaces: Assessment of Benefits and Costs of a Policy Intervention | ||||
Brief Summary | 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. | ||||
Detailed Description | 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. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Masking Description: Participants were not aware of the condition in which their organization was enrolled. Primary Purpose: Prevention
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Condition ICMJE | Skin Cancer | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
1990 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | July 31, 2017 | ||||
Actual Primary Completion Date | April 30, 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03281161 | ||||
Other Study ID Numbers ICMJE | 5R01CA187191-02( U.S. NIH Grant/Contract ) 5R01CA187191-02 ( U.S. NIH Grant/Contract ) 0284 ( Other Identifier: Klein Buendel, Inc. ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Klein Buendel, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Klein Buendel, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Klein Buendel, Inc. | ||||
Verification Date | October 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |