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Trial Title:
Virtual Sun Safe Workplaces Ph II (SSW Works)
NCT ID:
NCT05774600
Condition:
Skin Cancer
Occupational Exposure
Conditions: Official terms:
Skin Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
SSW Works
Description:
SSW Works is a behavioral, culturally tailored online intervention for skin cancer
prevention amongst outdoor workers in the United States.
Arm group label:
SSW Works
Intervention type:
Behavioral
Intervention name:
Minimal Information Control
Description:
Provision of online materials for skin cancer prevention.
Arm group label:
Minimal Information Control
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.
Criteria for eligibility:
Criteria:
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 Exclusion Criteria:
- Read a language other than English or Spanish
- Employee Exclusion Criteria:
- Read a language other than English or Spanish
- Work exclusively indoors
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Klein Buendel
Address:
City:
Golden
Zip:
80401
Country:
United States
Start date:
June 1, 2023
Completion date:
August 31, 2024
Lead sponsor:
Agency:
Klein Buendel, Inc.
Agency class:
Industry
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Klein Buendel, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05774600