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Virtual Sun Safe Workplaces Ph II (SSW Works)

Primary Purpose

Skin Cancer, Occupational Exposure

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SSW Works
Minimal Information Control
Sponsored by
Klein Buendel, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Klein Buendel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SSW Works

Minimal Information Control

Arm Description

SSW Works, is a virtual learning environment (VLE) for automated, comprehensive, on-demand, tailored distribution of the SSW program to private and public employers with outdoor workers. It will be delivered in both English and Spanish to managers and employees who work outdoors to reduce risk for skin cancer.

Workplaces randomized to the control condition will receive a set of printed materials on occupational sun safety (1 mailing per year) as an attention control. These will include posters on personal protection and skin cancer incidence, risk assessment brochure, American Academy of Dermatology SPOT bookmark showing the ABCDEs of melanoma and skin self-examination, and a sun safety tip card from OSHA.

Outcomes

Primary Outcome Measures

Change from Baseline Employee Sun Protection Practices at 1 year
Employees 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.
Change from Baseline Sunburn Prevalence at 1 year
Employees will report prevalence of sunburn in past 3 months on the job (yes/no; number).

Secondary Outcome Measures

Full Information

First Posted
February 9, 2023
Last Updated
August 24, 2023
Sponsor
Klein Buendel, Inc.
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05774600
Brief Title
Virtual Sun Safe Workplaces Ph II (SSW Works)
Official Title
SSW Works: A Virtual Learning Environment for Occupational Skin Cancer Prevention Ph II
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Klein Buendel, Inc.
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer, Occupational Exposure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SSW Works
Arm Type
Experimental
Arm Description
SSW Works, is a virtual learning environment (VLE) for automated, comprehensive, on-demand, tailored distribution of the SSW program to private and public employers with outdoor workers. It will be delivered in both English and Spanish to managers and employees who work outdoors to reduce risk for skin cancer.
Arm Title
Minimal Information Control
Arm Type
Active Comparator
Arm Description
Workplaces randomized to the control condition will receive a set of printed materials on occupational sun safety (1 mailing per year) as an attention control. These will include posters on personal protection and skin cancer incidence, risk assessment brochure, American Academy of Dermatology SPOT bookmark showing the ABCDEs of melanoma and skin self-examination, and a sun safety tip card from OSHA.
Intervention Type
Behavioral
Intervention Name(s)
SSW Works
Intervention Description
SSW Works is a behavioral, culturally tailored online intervention for skin cancer prevention amongst outdoor workers in the United States.
Intervention Type
Behavioral
Intervention Name(s)
Minimal Information Control
Intervention Description
Provision of online materials for skin cancer prevention.
Primary Outcome Measure Information:
Title
Change from Baseline Employee Sun Protection Practices at 1 year
Description
Employees 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.
Time Frame
Baseline assessment, 1 year assessment
Title
Change from Baseline Sunburn Prevalence at 1 year
Description
Employees will report prevalence of sunburn in past 3 months on the job (yes/no; number).
Time Frame
Baseline assessment, 1 year assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Buller, MA
Organizational Affiliation
Kle
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klein Buendel
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States

12. IPD Sharing Statement

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Virtual Sun Safe Workplaces Ph II (SSW Works)

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