Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05146622
Study type Observational
Source Klein Buendel, Inc.
Contact
Status Completed
Phase
Start date October 28, 2021
Completion date June 30, 2022

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02721459 - XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma Phase 1
Completed NCT03740815 - Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection N/A
Recruiting NCT05779423 - Cryoablation+Ipilimumab+Nivolumab in Melanoma Phase 2
Terminated NCT01468818 - Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma Phase 2
Completed NCT01820234 - Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event N/A
Completed NCT00535769 - Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use Phase 0
Completed NCT00526032 - Melanoma Detection by Oblique-Incidence Optical Spectroscopy N/A
Completed NCT00588341 - Phase II Trial of Neoadjuvant Temozolomide in Melanoma Patients With Palpable Stage III or IV Disease Undergoing Complete Surgical Resection Phase 2
Active, not recruiting NCT01447199 - The Molecular Predisposition to Hereditary Nonpolyposis Colon Cancer (HNPCC)
Enrolling by invitation NCT04758988 - AI Augmented Training for Skin Specialists N/A
Not yet recruiting NCT04534868 - Patient Acceptance And Satisfaction of Teledermoscopy In General Practice In a Belgian Rural Area N/A
Recruiting NCT04138342 - Topical Fluorescent Nanoparticles Conjugated Somatostatin Analog for Suppression and Bioimaging Breast Cancer Phase 1
Completed NCT03673917 - Cosmetology Students and Skin Cancer N/A
Recruiting NCT04341064 - Sun-safe Habits Intervention and Education Phase 3
Completed NCT04206995 - Cancer Sensing: Evaluation of Odour Sampling Techniques
Recruiting NCT05574101 - A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer Phase 2
Not yet recruiting NCT05860881 - Topical Sirolimus in Chemoprevention of Facial Squamous Cell Carcinomas in Solid Organ Transplant Recipients (SiroSkin) Phase 3
Recruiting NCT05068310 - Applicability of a Cellular Resolution Full-field OCT Image System for Pigmented and Non-pigmented Skin Tumors
Recruiting NCT03889899 - Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia. N/A
Withdrawn NCT04099446 - A Non-Interventional Pilot Study to Explore the Skin Microbes in Skin Cancer