Virtual Sun Safe Workplaces Ph I

Skin Cancer Clinical Trial

— SSW Works  

Official title:

SSW Works: A Virtual Learning Environment for Occupational Skin Cancer Prevention Phase I

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05146622
• Other study ID #: 0333
• Secondary ID: 1R44CA257778-01A
• Status: Completed
• Start date: October 28, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2022
• Source: Klein Buendel, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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 our 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. Our 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, we 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 our 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Employed part-/full-time at a participating employer

• Work at least 5 hours outdoors per week

• Read English or Spanish

• Complete the pretest survey

• Employed in a management/supervisory position

• Responsible for worksite safety/health policy or education

• Consent to participate

Exclusion Criteria:

• Work exclusively indoors

• Can read neither English nor Spanish

Related Conditions & MeSH terms

• Skin Cancer
• Skin Neoplasms

Intervention

Behavioral:
• Workplaces in the World
Formative research activities to better understand attitudes and behaviors of outdoor workers with respect to UV safety.

Locations

Country	Name	City	State
United States	Klein Buendel, Inc.	Golden	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Klein Buendel, Inc.	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Formative Research Activities	Focus Groups and Semi-structured Interviews	Baseline Only