- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05146622
Virtual Sun Safe Workplaces Ph I (SSW Works)
November 2, 2022 updated by: Klein Buendel, Inc.
SSW Works: A Virtual Learning Environment for Occupational Skin Cancer Prevention Phase I
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
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.
Study Type
Observational
Enrollment (Actual)
104
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Colorado
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Golden, Colorado, United States, 80401
- Klein Buendel, Inc.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Outdoor workers in the United States.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Formative Research
Outdoor workers in the United States.
|
Formative research activities to better understand attitudes and behaviors of outdoor workers with respect to UV safety.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Formative Research Activities
Time Frame: Baseline Only
|
Focus Groups and Semi-structured Interviews
|
Baseline Only
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 28, 2021
Primary Completion (ACTUAL)
June 30, 2022
Study Completion (ACTUAL)
June 30, 2022
Study Registration Dates
First Submitted
November 23, 2021
First Submitted That Met QC Criteria
November 23, 2021
First Posted (ACTUAL)
December 7, 2021
Study Record Updates
Last Update Posted (ACTUAL)
November 4, 2022
Last Update Submitted That Met QC Criteria
November 2, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0333
- 1R44CA257778-01A1 (NIH)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.