Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05774600 |
| Other study ID # |
0339 |
| Secondary ID |
4R44CA257778-02 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2023 |
| Est. completion date |
August 31, 2024 |
Study information
| Verified date |
August 2023 |
| Source |
Klein Buendel, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
