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Virtual Sun Safe Workplaces Ph II (SSW Works)

SSW Works: A Virtual Learning Environment for Occupational Skin Cancer Prevention Ph II

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05774600
Enrollment
543
Registered
2023-03-17
Start date
2023-06-01
Completion date
2025-08-28
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Occupational Exposure, Skin Cancer

Brief 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 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.

Interventions

BEHAVIORALSSW Works

SSW Works is a behavioral, culturally tailored online intervention for skin cancer prevention amongst outdoor workers in the United States.

BEHAVIORALMinimal Information Control

Provision of online materials for skin cancer prevention.

Sponsors

Klein Buendel, Inc.
Lead SponsorINDUSTRY
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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 * 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

Exclusion criteria

* Manager

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline Employee Sun Protection Practices at 1 YearBaseline assessment, 1 year assessmentEmployees 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 YearBaseline assessment, 1 year assessmentThe percentage change in employees reporting any sunburn in the last 3 months on the job from pretest to posttest.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMary Buller, MA

Klein Buendel, Inc.

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
11 Participants
Age, Categorical
Between 18 and 65 years
294 Participants
Age, Continuous43.8 years
STANDARD_DEVIATION 13.2
Ethnicity (NIH/OMB)
Hispanic or Latino
39 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
195 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
53 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
5 Participants
Race (NIH/OMB)
Black or African American
20 Participants
Race (NIH/OMB)
More than one race
12 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
Unknown or Not Reported
21 Participants
Race (NIH/OMB)
White
434 Participants
Sex: Female, Male
Female
170 Participants
Sex: Female, Male
Male
221 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 3150 / 228
other
Total, other adverse events
0 / 3150 / 228
serious
Total, serious adverse events
0 / 3150 / 228

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026