Skin CancerSSW2NCT03281161
Sun Safe Workplaces: Assessment of Benefits and Costs of a Policy Intervention
A study testing Sun Safe Workplaces Program in people with Skin Cancer, run by Klein Buendel, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Sun Safe Workplaces Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,990 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Feb 2015to 31 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participation in the prior Sun Safe Workplaces: A Campaign on Sun Protection Policies for Outdoor Workers.
- A local government organization with employees who worked outdoors in at least one of the following service areas: public works, public safety, and parks and recreation,
- Having a full time executive
- Having a population of at least 3000 residents
- Being employed at a participating local government organization as a manager or employee?
- Being employed at a participating local government organization in a job requiring outdoor work at least part of the time.
Who cannot join
- Organization had participated in the authors' previous occupational sun protection project.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Denver
Aurora, Colorado, 80045-0508
Kaiser Foundation Research Institute
Oakland, California, 94612-3466
About this study
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.
Read the 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.
- Conditions
- Skin Cancer
- Being tested
- Sun Safe Workplaces Program, Attention Control
- Keywords
- skin cancer, prevention, worksite, policy, cost and effectiveness, implementation
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sun Safe Workplaces ProgramBehavioural
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.
Attention ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sun Safe Workplaces Program | Experimental | 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. Receives: Behavioral: Sun Safe Workplaces Program |
| Attention Control | Active comparator | 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. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey of sun protection practices by employees.
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.
Measured: 9 Months
Secondary outcomes (6)
Observational checklist to review sun protections items within the workplace.
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.
Measured: 9 months
In-depth manager interview to assess relationship of employer sun safety actions to employee sun safety.
Analysis of the association of employer actions (education only vs. education plus policy) on sun safety with employee's sun protection practices.
Measured: 9 Months
In-depth manager survey to assess relationship of employer sun safety actions to employee sun safety.
Analysis of the association of employer actions (education only vs. education plus policy) on sun safety with employee's sun protection practices.
Measured: 9 Months
Extraction of costs from parent study ledgers to conduct economic analysis of the SSW intervention.
Cost information from the SSW parent study project ledgers was extracted for the economic evaluation of the benefits and costs of the intervention.
Measured: 9 Months
In-depth manager interview to conduct economic analysis of the SSW intervention.
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.
Measured: 9 Months
Analysis of employee surveys to compare the impact of workplaces implementing education-only versus education plus policy adoption on employee sun safety practices.
To compare the actions of intervention employers implementing education, intervention employers implementing education and adopting policy on employee sun safety.
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start27 Feb 2015
- Primary completion30 Apr 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,990 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Kaiser Foundation Research Institute, University of Colorado, Denver
- Responsible party
- Sponsor
- Investigators
- David Buller, PhD, Principal investigator, Klein Buendel, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281161
- Sponsor's protocol ID
- 5R01CA187191-02
- Other IDs
- 5R01CA187191-02, 0284
- Acronym
- SSW2
- Status last verified
- Oct 2017
- First submitted
- 6 Sep 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sun Safe Workplaces: Assessment of Benefits and Costs of a Policy Intervention
- ClinicalTrials.gov ID
- NCT03281161
- Acronym / sponsor ID
- SSW2 / 5R01CA187191-02
- Conditions
- Skin Cancer
- Keywords
- skin cancer, prevention, worksite, policy, cost and effectiveness, implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,990 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Kaiser Foundation Research Institute, University of Colorado, Denver
- Study start
- 27 Feb 2015 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sun Safe Workplaces Program | Experimental | Behavioral: Sun Safe Workplaces ProgramA 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. |
| Attention Control | Active comparator | Behavioral: Attention ControlA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participation in the prior Sun Safe Workplaces: A Campaign on Sun Protection Policies for Outdoor Workers.
- A local government organization with employees who worked outdoors in at least one of the following service areas: public works, public safety, and parks and recreation,
- Having a full time executive
- Having a population of at least 3000 residents
- Being employed at a participating local government organization as a manager or employee?
Key exclusion criteria (1 listed)
- Organization had participated in the authors' previous occupational sun protection project.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sun Safe Workplaces ProgramA 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. | Behavioural | Sun Safe Workplaces Program |
| Attention ControlA 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. | Behavioural | Attention Control |
Primary outcome
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.
6 secondary outcomes
Observational checklist to review sun protections items within the workplace.
Time frame: 9 months
In-depth manager interview to assess relationship of employer sun safety actions to employee sun safety.
Time frame: 9 Months
In-depth manager survey to assess relationship of employer sun safety actions to employee sun safety.
Time frame: 9 Months
Extraction of costs from parent study ledgers to conduct economic analysis of the SSW intervention.
Time frame: 9 Months
In-depth manager interview to conduct economic analysis of the SSW intervention.
Time frame: 9 Months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Buller, PhD principal investigator
Klein Buendel, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sun Safe Workplaces Program in people with Skin Cancer, run by Klein Buendel, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survey of sun protection practices by employees. (time frame: 9 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.