Skin CancerSSW-TNCT03278340
Using Technology to Scale-Up an Occupational Sun Protection Policy Program
A study testing Sun Safe Workplaces - Technology and Sun Safe Workplaces -In Person in people with Skin Cancer, run by Klein Buendel, Inc. at 2 sites in United States.
Trial summary
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. 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 - Technology and Sun Safe Workplaces -In Person
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,644 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jul 2017to 31 Jul 2024
- 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
- Fire Departments and State DOTs in the United States, agreeing to participate, providing written policies at pretest and having at least 6 managers and 50 workers complete the pretest.
- Being a senior manager of a fire department or state DOT located in the United States. Criteria include a) being in a senior management position; b) responsible for work-site safety/health policy and education; c) consenting to participate, and d) completing the pretest. This includes city/county managers, human resources directors, risk managers, and managers of facilities, fire, roads and transportation departments
- Being an employee of a fire department or state DOT located in the United States. Criteria includes a) being employed part/full-time at the employer, b) working at least part of daytime hours outdoors, c) consenting to participate, and d) completing the pretest survey.
Who cannot join
- Prior participation in the Sun Safe Workplaces program
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Klein Buendel, Inc.
Golden, Colorado, 80403
Kaiser Foundation Research Institute
Oakland, California, 94612-3466
About this study
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.
Read the detailed description
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.
- Conditions
- Skin Cancer
- Being tested
- Sun Safe Workplaces - Technology, Sun Safe Workplaces -In Person
- Keywords
- Skin Cancer, Prevention, Policy, Worksite, Scale-up, Cost and Effectiveness
- 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 - TechnologyBehavioural
Also called SSW-T
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.
Sun Safe Workplaces -In PersonBehavioural
Also called SSW-IP
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).
| Study group | Role | What they receive |
|---|---|---|
| Sun Safe Workplaces - Technology (SSW-T) | Experimental | 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). Receives: Behavioral: Sun Safe Workplaces - Technology |
| Sun Safe Workplaces - In Person (SSW-IP) | Active comparator | 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. Receives: Behavioral: Sun Safe Workplaces -In Person |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation of Occupational Sun Protection Policy
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).
Measured: Baseline to 2 years followup
Implementation of Sun Safety Education
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
Measured: Baseline to 2 year followup
Secondary outcomes (4)
Economic Evaluation of the SSW-IP and SSW-T Intervention Programs
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.
Measured: Baseline to 2 year followup
Changes in Workplace Environment for Sun Safety
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.
Measured: Baseline to 2 year followup
Other Policy-related Measures
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]).
Measured: Baseline to 2 year followup
Employees Sun Protection Practices
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.
Measured: Baseline to 2 year followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start14 Jul 2017
- Primary completion1 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 2,644 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David Buller, PhD, Principal investigator, Klein Buendel, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278340
- Sponsor's protocol ID
- 0316
- Other IDs
- 0316, R01CA210259
- Acronym
- SSW-T
- Status last verified
- Nov 2024
- First submitted
- 6 Sep 2017
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buller DB, Buller MK, Meenan R, Cutter GR, Berteletti J, Eye R, Walkosz BJ, Pagoto S. Design and baseline data of a randomized trial comparing two methods for scaling-up an occupational sun protection intervention. Contemp Clin Trials. 2020 Oct;97:106147. doi: 10.1016/j.cct.2020.106147. Epub 2020 Sep 15.
PubMed 32942054
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Technology to Scale-Up an Occupational Sun Protection Policy Program
- ClinicalTrials.gov ID
- NCT03278340
- Acronym / sponsor ID
- SSW-T / 0316
- Conditions
- Skin Cancer
- Keywords
- Skin Cancer, Prevention, Policy, Worksite, Scale-up, Cost and Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,644 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente, National Cancer Institute (NCI)
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 11 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.
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.
Detailed description
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.
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 - Technology (SSW-T) | Experimental | Behavioral: Sun Safe Workplaces - TechnologyProgram 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). |
| Sun Safe Workplaces - In Person (SSW-IP) | Active comparator | Behavioral: Sun Safe Workplaces -In PersonProgram 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fire Departments and State DOTs in the United States, agreeing to participate, providing written policies at pretest and having at least 6 managers and 50 workers complete the pretest.
- Being a senior manager of a fire department or state DOT located in the United States. Criteria include a) being in a senior management position; b) responsible for work-site safety/health policy and education; c) consenting to participate, and d) completing the pretest. This includes city/county managers, human resources directors, risk managers, and managers of facilities, fire, roads and transportation departments
- Being an employee of a fire department or state DOT located in the United States. Criteria includes a) being employed part/full-time at the employer, b) working at least part of daytime hours outdoors, c) consenting to participate, and d) completing the pretest survey.
Key exclusion criteria (1 listed)
- Prior participation in the Sun Safe Workplaces program
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 - TechnologyAlso: SSW-TAfter 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. | Behavioural | Sun Safe Workplaces - Technology (SSW-T) |
| Sun Safe Workplaces -In PersonAlso: SSW-IPAfter 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). | Behavioural | Sun Safe Workplaces - In Person (SSW-IP) |
Primary outcome
Implementation of Occupational Sun Protection Policy
Time frame: Baseline to 2 years followup
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).
Implementation of Sun Safety Education
Time frame: Baseline to 2 year followup
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
4 secondary outcomes
Economic Evaluation of the SSW-IP and SSW-T Intervention Programs
Time frame: Baseline to 2 year followup
Changes in Workplace Environment for Sun Safety
Time frame: Baseline to 2 year followup
Other Policy-related Measures
Time frame: Baseline to 2 year followup
Employees Sun Protection Practices
Time frame: Baseline to 2 year followup
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 14 Nov 2024.
- Derived from this study: PubMed 32942054Buller DB, Buller MK, Meenan R, Cutter GR, Berteletti J, Eye R, Walkosz BJ, Pagoto S. Design and baseline data of a randomized trial comparing two methods for scaling-up an occupational sun protection intervention. Contemp Clin Trials. 2020 Oct;97:106147. doi: 10.1016/j.cct.2020.106147. Epub 2020 Sep 15.
- 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 - Technology and Sun Safe Workplaces -In Person 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 3 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 14 Nov 2024. 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?
Implementation of Occupational Sun Protection Policy (time frame: Baseline to 2 years followup). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03278340, which also lists 1 linked publication.
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 14 Nov 2024.