Skin CancerNCT05774600
Virtual Sun Safe Workplaces Ph II (SSW Works)
A study testing SSW Works in people with Skin Cancer and Occupational Exposure, run by Klein Buendel, Inc. at 1 site in United States.
Trial summary
Americans who work outdoors are exposed to an extreme amount of solar ultraviolet radiation over a lifetime that substantially increases their risk for developing skin cancer. In Phase I, the feasibility of a virtual learning environment (VLE) for distributing the effective Sun Safe Workplaces (SSW) intervention to… 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, Occupational Exposure
- What is being tested?
- SSW Works
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 543 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 28 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Manager Inclusion Criteria:
- Employed in a manager or supervisory position
- Responsible for worksite safety / health policy or education
- Read English or Spanish
- Consent to participate
- Complete the pre-test survey
Show all 12Show fewer
- Employee Inclusion Criteria:
- Employed part-time / full-time at a participating employer
- Work at least 5 hours outdoors a week
- Read English or Spanish
- Consent to participate
- Complete the pre-test survey
Who cannot join
- Manager Exclusion Criteria:
- Read a language other than English or Spanish
- Employee Exclusion Criteria:
- Read a language other than English or Spanish
- Work exclusively indoors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SSW Works: A Virtual Learning Environment for Occupational Skin Cancer Prevention Ph II
Americans who work outdoors are exposed to an extreme amount of solar ultraviolet radiation over a lifetime that substantially increases their risk for developing skin cancer. In Phase I, the feasibility of a virtual learning environment (VLE) for distributing the effective Sun Safe Workplaces (SSW) intervention to American employers will be established with input from senior managers and Hispanic and African American outdoor workers and development and evaluation of a prototype of the SSW Works VLE. In Phase II, the full SSW Works will be produced and tested for effectiveness at improving outdoor workers' sun protection in a randomized trial enrolling employers nationwide.
Read the detailed description
Americans who work outdoors are exposed to an extreme amount of solar ultraviolet radiation (UV) over a lifetime that substantially increases their risk for developing skin cancer. Annually, skin cancer is diagnosed in over 3.5 million U.S. adults, melanoma kills nearly 7,000 Americans, and treatment costs at least $8 billion. The U.S. Surgeon General has identified occupational sun safety as a national priority. The team has spent the past two decades developing a successful comprehensive approach to occupational sun protection in 5 trials funded largely by the National Cancer Institute. Sun Safe Workplaces (SSW) combines policy and education to increase workplace actions on sun safety and employee sun protection practices. In this SBIR Fast-Track application, the investigators will develop a virtual learning environment (VLE), SSW Works, to distribute the SSW program to American workplaces. It will be comprised of a database, content management (interactive toolbox), and media platform (trackable training) that tailors the SSW program to management's readiness to innovate on sun safety based Diffusion of Innovations Theory. SSW Works will better integrate SSW into safety training by improving appropriateness for Hispanic and African American workers and conforming with the latest learning management systems technology (LMS). Strong scientific premise comes from the published literature and the team's 5 previous studies that demonstrated SSW is feasible and effective in public works, public safety, and outdoor recreation workplaces. The Phase I specific aims will establish the feasibility of SSW Works by 1) creating and validating an algorithm to tailor resources and implementation strategies to employers' stages in the diffusion of innovations process; 2) identifying unique attitudes, barriers, and practices related to sun safety among Hispanic and African American employees in focus group discussion and adjusting the SSW content; and 3) creating a prototype of the SSW Works VLE, including inputs, staging algorithm and tailored report, employee training compatible with a popular LMS, and storyboards of brief videos for managers and employees and testing it for feasibility and usability with managers and Hispanic and African American outdoor workers, and confirming that the training can operate within a popular LMS. In Phase II, SSW Works will be fully programmed and tested for effectiveness by achieving the specific aims of: 1) producing the full SSW Works, in English and Spanish, for distribution of the evidence-based SSW and 2) conducting a randomized controlled trial with 20 workplaces evaluating impact of SSW distributed over the SSW Works on employees' sun safety practices (primary outcome). The primary hypothesis is: compared to employers in the minimal information control group, employers assigned to receive SSW Works will have employees that practice more sun protection at posttest. The SBIR Fast-Track research is significant and innovative. SSW Works will have high impact and commercial potential because outdoor workforce is large and at very high risk for skin cancer, improving sun safety will reduce health care costs and save lives, and there are few commercial competitors.
- Conditions
- Skin Cancer, Occupational Exposure
- Being tested
- SSW Works, Minimal Information Control
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSW WorksBehavioural
SSW Works is a behavioral, culturally tailored online intervention for skin cancer prevention amongst outdoor workers in the United States.
Minimal Information ControlBehavioural
Provision of online materials for skin cancer prevention.
| Study group | Role | What they receive |
|---|---|---|
| SSW Works | Experimental | SSW Works, is a virtual learning environment (VLE) for automated, comprehensive, on-demand, tailored distribution of the SSW program to private and public employers with outdoor workers. It will be delivered in both English and Spanish to managers and employees who work outdoors to reduce risk for skin cancer. Receives: Behavioral: SSW Works |
| Minimal Information Control | Active comparator | Workplaces randomized to the control condition will receive a set of printed materials on occupational sun safety (1 mailing per year) as an attention control. These will include posters on personal protection and skin cancer incidence, risk assessment brochure, American Academy of Dermatology SPOT bookmark showing the ABCDEs of melanoma and skin self-examination, and a sun safety tip card from OSHA. Receives: Behavioral: Minimal Information Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Employee Sun Protection Practices at 1 Year
Employees will report frequency of sun protection at work (i.e., sunscreen with SPF 30+, long-sleeved shirts, long pants, hat with wide-brim, sunglasses, shade use, limit midday sun exposure, and have sunscreen, hat and eye protection at all times [1=never, 5=always]). SPF 30+ is advised in SSW to account for typical under-application that reduces effective SPF.
Measured: Baseline assessment, 1 year assessment
Percentage Change From Baseline Employee Sunburn Prevalence at 1 Year
The percentage change in employees reporting any sunburn in the last 3 months on the job from pretest to posttest.
Measured: Baseline assessment, 1 year assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start1 Jun 2023
- Primary completion25 Feb 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Outcomes assessor
- Enrolment
- 543 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mary Buller, MA, Principal investigator, Klein Buendel, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774600
- Sponsor's protocol ID
- 0339
- Other IDs
- 4R44CA257778-02
- Status last verified
- Mar 2026
- First submitted
- 9 Feb 2023
- Last updated
- 19 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SSW Works: A Virtual Learning Environment for Occupational Skin Cancer Prevention Ph II
- ClinicalTrials.gov ID
- NCT05774600
- Acronym / sponsor ID
- 0339
- Conditions
- Skin Cancer, Occupational Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 543 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Posted 19 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Americans who work outdoors are exposed to an extreme amount of solar ultraviolet radiation over a lifetime that substantially increases their risk for developing skin cancer. In Phase I, the feasibility of a virtual learning environment (VLE) for distributing the effective Sun Safe Workplaces (SSW) intervention to American employers will be established with input from senior managers and Hispanic and African American outdoor workers and development and evaluation of a prototype of the SSW Works VLE. In Phase II, the full SSW Works will be produced and tested for effectiveness at improving outdoor workers' sun protection in a randomized trial enrolling employers nationwide.
Detailed description
Americans who work outdoors are exposed to an extreme amount of solar ultraviolet radiation (UV) over a lifetime that substantially increases their risk for developing skin cancer. Annually, skin cancer is diagnosed in over 3.5 million U.S. adults, melanoma kills nearly 7,000 Americans, and treatment costs at least $8 billion. The U.S. Surgeon General has identified occupational sun safety as a national priority. The team has spent the past two decades developing a successful comprehensive approach to occupational sun protection in 5 trials funded largely by the National Cancer Institute. Sun Safe Workplaces (SSW) combines policy and education to increase workplace actions on sun safety and employee sun protection practices. In this SBIR Fast-Track application, the investigators will develop a virtual learning environment (VLE), SSW Works, to distribute the SSW program to American workplaces. It will be comprised of a database, content management (interactive toolbox), and media platform (trackable training) that tailors the SSW program to management's readiness to innovate on sun safety based Diffusion of Innovations Theory. SSW Works will better integrate SSW into safety training by improving appropriateness for Hispanic and African American workers and conforming with the latest learning management systems technology (LMS). Strong scientific premise comes from the published literature and the team's 5 previous studies that demonstrated SSW is feasible and effective in public works, public safety, and outdoor recreation workplaces. The Phase I specific aims will establish the feasibility of SSW Works by 1) creating and validating an algorithm to tailor resources and implementation strategies to employers' stages in the diffusion of innovations process; 2) identifying unique attitudes, barriers, and practices related to sun safety among Hispanic and African American employees in focus group discussion and adjusting the SSW content; and 3) creating a prototype of the SSW Works VLE, including inputs, staging algorithm and tailored report, employee training compatible with a popular LMS, and storyboards of brief videos for managers and employees and testing it for feasibility and usability with managers and Hispanic and African American outdoor workers, and confirming that the training can operate within a popular LMS. In Phase II, SSW Works will be fully programmed and tested for effectiveness by achieving the specific aims of: 1) producing the full SSW Works, in English and Spanish, for distribution of the evidence-based SSW and 2) conducting a randomized controlled trial with 20 workplaces evaluating impact of SSW distributed over the SSW Works on employees' sun safety practices (primary outcome). The primary hypothesis is: compared to employers in the minimal information control group, employers assigned to receive SSW Works will have employees that practice more sun protection at posttest. The SBIR Fast-Track research is significant and innovative. SSW Works will have high impact and commercial potential because outdoor workforce is large and at very high risk for skin cancer, improving sun safety will reduce health care costs and save lives, and there are few commercial competitors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSW Works | Experimental | Behavioral: SSW WorksSSW Works, is a virtual learning environment (VLE) for automated, comprehensive, on-demand, tailored distribution of the SSW program to private and public employers with outdoor workers. It will be delivered in both English and Spanish to managers and employees who work outdoors to reduce risk for skin cancer. |
| Minimal Information Control | Active comparator | Behavioral: Minimal Information ControlWorkplaces randomized to the control condition will receive a set of printed materials on occupational sun safety (1 mailing per year) as an attention control. These will include posters on personal protection and skin cancer incidence, risk assessment brochure, American Academy of Dermatology SPOT bookmark showing the ABCDEs of melanoma and skin self-examination, and a sun safety tip card from OSHA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Manager Inclusion Criteria:
- Employed in a manager or supervisory position
- Responsible for worksite safety / health policy or education
- Read English or Spanish
- Consent to participate
Key exclusion criteria (5 listed)
- Manager Exclusion Criteria:
- Read a language other than English or Spanish
- Employee Exclusion Criteria:
- Read a language other than English or Spanish
- Work exclusively indoors
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 |
|---|---|---|
| SSW WorksSSW Works is a behavioral, culturally tailored online intervention for skin cancer prevention amongst outdoor workers in the United States. | Behavioural | SSW Works |
| Minimal Information ControlProvision of online materials for skin cancer prevention. | Behavioural | Minimal Information Control |
Primary outcome
Change From Baseline Employee Sun Protection Practices at 1 Year
Time frame: Baseline assessment, 1 year assessment
Employees will report frequency of sun protection at work (i.e., sunscreen with SPF 30+, long-sleeved shirts, long pants, hat with wide-brim, sunglasses, shade use, limit midday sun exposure, and have sunscreen, hat and eye protection at all times [1=never, 5=always]). SPF 30+ is advised in SSW to account for typical under-application that reduces effective SPF.
Percentage Change From Baseline Employee Sunburn Prevalence at 1 Year
Time frame: Baseline assessment, 1 year assessment
The percentage change in employees reporting any sunburn in the last 3 months on the job from pretest to posttest.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mary Buller, MA principal investigator
Klein Buendel, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SSW Works in people with Skin Cancer and Occupational Exposure, run by Klein Buendel, Inc. at 1 site 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 12 inclusion and 5 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 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 19 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline Employee Sun Protection Practices at 1 Year (time frame: Baseline assessment, 1 year assessment). 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?
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 19 Mar 2026.