SSW Works: A Virtual Learning Environment for Occupational Skin Cancer Prevention Ph II
Phase: NA
Conditions: Skin Cancer, Occupational Exposure
Sponsor: Klein Buendel, Inc.

 
 
 
 
 
 
 
 
SSW Works: A Virtual Learning Environment for 
Occupational Skin Cancer Prevention Ph II 
 
NCT05774600  
 
 
Study Protocol and Statistical Analysis Plan 
 
 
August 15, 2025 
 
 
 
 

Study Protocol 
3C. Approach 
We have already developed a) the effective SSW intervention that uses in-person meetings and 
training and b) research methods for evaluating occupational sun safety interventions. So, potential 
feasibility of SSW Works is high. We propose to achieve Phase I milestones of culturally adapting 
content for Hispanic and African American workers, automating the algorithm for tailoring intervention to 
employers’ readiness to innovate, creating the VLE technology platform, and confirming it is usable, 
feasible, and acceptable for full-production and evaluation in Phase II. 
 
3C.1. SSW Works: Virtual Learning Environment for Occupational Skin Cancer Prevention 
The innovative product, 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. Most of the SSW materials that will be adapted and integrated into SSW Works 
were developed in our prior trials, including a) introductory video, b) sun safety checklist, c) SSW 
Report template, d) manager briefs, e) policy writing tool, f) 30-minute online employee training, g) 
employee communication to inform and motivate on-the-job sun safety (articles, brochures, posters, tip 
cards, and stickers), and h) sun safety environmental audit. It will provide guidance and resources to 
managers for implementing workplace policy and employee education and communications through a 
combination of three custom-built technology platforms: database platform (registration, staging inputs, 
and algorithm), content management platform (interactive toolbox with report and resources), and 
media platform (employee training and videos for managers and employees). The user interface will 
organize the advice and resources into two sections: 
• 
Manager Interactive Toolbox: Tailored support for managers in policy adoption and program 
implementation for employee sun safety. Features: 2.5-minute introductory video; forms to input 
workplace policy, actions, and characteristics; tailored, real-time SSW Report based on these 
inputs; manager briefs (e.g., topical white papers) and videos; policy writing tool; and workplace 
audit tool. 
• 
Employee Training: Library of resources to promote personal sun protection by employees. 
Resources include: a 30-minute online employee training and assessment compatible with 
different LMS and employee communications (articles; brochures; signage; tip cards; skills 
videos). SSW Works will also reflect findings from formative research and prototype testing. 
Specifically, it will address facilitators/barriers to sun protection among Hispanics and African 
Americans, be culturally-representative (e.g., images will be selected from KB’s Real Health 
Photos stock art library), and be available in English and Spanish (using KB’s translation-back-
translation procedures). The SSW training will conform with various LMS technology to ensure it 
can easily be part of regular training for employees. 
3C.1.1. Staging Algorithm and SSW Report: Using our staging grid that tailors advice on 
occupational sun safety based on DIT61 principles, investigators and media developers will create an 
algorithm to automatically perform tailoring of SSW to managers readiness to innovate, previously done 
by intervention staff. It will use three inputs on employers’ current policies and actions: 
1. Policy Checklist – users report content of workplace policy directly or indirectly on sun safety, 
based upon the 15 policy categories in our current SSW policy coding protocol. 
2. Manager Survey – users report opinions about occupational sun safety (risk of skin cancer; 
support for policy), existing sun safety policy and standard operating procedures (awareness, 
support, and enforcement), and existing sun safety actions, training, and messages. 
3. Sun Safety Checklist – users report willingness to implement actions for a model sun safety policy 
(whether the workplace is already doing, might do, or would not do each action). 
Using input forms, staging algorithm, and report template, SSW Works will generate a customized 
SSW Report and Action Plan for the workplace. It will describe gaps in sun safety policy/education and 
support for/resistance to them, and provide resources on sun safety (e.g., briefs/videos) and plans for 
implementing sun safety through policy changes, employee training, and workplace actions. Guidance 
will be matched to DIT stages of managers’ readiness to innovate: 

• 
Agenda Setting – Convincing managers that UV exposure increases risk for skin cancer and 
policy/actions in SSW will reduce this risk before addressing program fit and implementation. 
• 
Matching – Describe ways policy, education and actions fit in work processes/environments 
before addressing implementation. 
• 
Structuring – Focus on developing plans for implementing policy, education, and actions. 
• 
Clarifying – Reinforce implementation and anticipate, monitor, and reduce opposition to 
implemented sun safety practices by employees, managers, and clients. 
3C.1.2. Managers Briefs and Videos: Manager briefs (1-2 pages on individual topics in more 
detail) will aid decision-making and implementation. We will produce five 5-minute “YouTube” style 
videos to accompany briefs. Tentatively, we plan briefs/videos on: UV risk in outdoor work, sun safety 
workplace audit; selecting/sourcing PPE (e.g., wide-brimmed hats; bulk sunscreen), workplace policy, 
and planning implementation. Videos will contain slides, voiceovers, and animated/live actor 
demonstrations. 
3C.1.3. Employee Training Compatible with Learning Management System (LMS): Many 
organizations have adopted LMS, software that manages, tracks, and reports on employee training 
(i.e., registration, attendance, completion, and assessment). In our recent SSW trial, several state 
DOTs are using LMS and requested the 30-minute employee training be loaded into their LMS. 
However, the current training is in HTML5 format, not compatible with all LMS. KB media developers 
will re-program the employee training to be compatible with popular LMS (e.g., Edmodo, Moodle, 
Blackboard, SAP SuccessFactors, Thinkific, SkillSoft, Instructure, Saba Software, Cornerstone 
OnDemand, and Schoology60), based on our prior trial, Phase I interviews, and LMS literature so it can 
be institutionalized in the workplaces. This will involve formatting files for specific LMS requirements 
and ensuring SCORM-compliance. A training assessment (i.e., knowledge check) for LMS will measure 
employee sun safety knowledge and skills. 
      3C.1.4. Employee Skills Videos: In our SSW trial, managers requested short videos for safety 
meetings to reinforce employee training. We will produce five 5-minute videos in “YouTube” style on 
skills acquisition. Tentative topics are using UV Index; assessing personal risk; wearing protective 
clothing; using shade; and applying sunscreen. Videos will contain slides, voiceovers, and 
animated/live actor demonstrations. 
 
3C.2. Target Populations, Recruiting, and Inclusion/Exclusion Criteria for Phase I and II 
Target populations are employers, outdoor workers, and managers. We will recruit employers from 
diverse industries (e.g., agriculture, oil and gas exploration, construction, utilities, transportation, 
landscaping, outdoor recreation, public works/safety). In our SSW trial, employees were 66% age 31- 
60, 80% male, 93% white, 1% African American, 10% Hispanic, and 12% with Type I or II skin, and 
37% had a college/postgraduate degree. Males are least sun protective174,175; non-Hispanic whites 
are at highest risk for melanoma and skin cancer.176 Managers included human resources directors, 
risk managers, safety officers, resident engineers, and managers of facilities, maintenance, fire, and 
transportation. They were long-term employees (M=19.8 years) and worked some of the time outdoors 
(66%). Further, 55% were age 20-50 (M=48.9), 43% had a college/ postgraduate degree, and 91% 
were male. Also, 91% were white (6% Hispanic), 30% had Type I or II skin most susceptible to UV 
damage177 and 10% had had skin cancer. 
 
3C.3. Overview of Phase I Research and Timeline 
Phase I research will be completed in 9 months. Protocols will be developed and approved by Western 
IRB in Month 1. Employers and Hispanic and African American outdoor workers will provide input on 
the tailoring algorithm, LMS, and content for SSW Works during Months 2-3. A prototype SSW Works 
VLE will be produced in Months 4-5 and its acceptability, feasibility, and usability evaluated in Months 
6-7. Phase I results and feasibility of Phase II research will be evaluated in Month 9. 
 
3C.4. External Advisory Board 
An External Advisory Board (EAB) will review plans and provide input on Phase I/II activities. The EAB 
will be chaired by Barbara Walkosz, PhD. Members will include Robert Dellavalle, MD (dermatology), 
Cristian Gonzalez, MD (Hispanics & skin cancer), Robert Newton, PhD (African Americans & disease 
prevention), Patterson McKinlay (risk management), Dena Baldwin (human resources), and Tammy 

Wright (Vector Solutions, e-learning product development). In Phase I, EAB will help fill two open 
positions for expertise such as workers compensation insurance and workplace safety and meet in 
Month 1 to approve the protocols. In Month 9, it will review Phase I findings and advise on feasibility of 
the SSW Works and its evaluation in Phase II. In Phase II, the EAB will meet in Month 11 to approve 
Phase II protocols, in Month 17 to review fully-programmed SSW Works, and in Month 36 to review 
findings from the trial evaluation. Meeting notes will be prepared by project staff of each meeting and 
reviewed by research team. 
Milestones & Deliverables: Milestone 1: Approval of Phase I Research Procedures: In Month 1, the 
EAB will review and approve the Phase I research procedures. Deliverable 1: Approved Study Protocol. 
 
3C.5. Formative Research to Develop SSW Works (Month 2-3) 
      3C.5.1. Training Concept/Content Focus Groups: To refine SSW content for racial/ethnic 
minority employees in the outdoor workforce, Hispanic and African American outdoor workers recruited 
in Denver, Colorado will participate in focus groups (n=8) – 4 groups of Hispanics and 4 groups of 
African Americans (n=8 per group; 64 total) – to identify ethnic differences in their attitudes, barriers, 
and practices related to sun safety. They will be sent a link to view the SSW training and a set of 
materials promoting sun safety in the workplace for employees (e.g., fact sheets, posters, newsletter 
articles, etc.) before arriving at the focus group session. Focus groups aim to describe outdoor workers’ 
knowledge of workplace sun safety, sun protection on the job, perceived susceptibility to solar UV 
damage, benefits and harms of sun safety on the job, facilitators and barriers to sun safety, and content 
preferred in the occupational sun protection training and materials. Discussions will examine 
content/features that promote cultural appropriateness, including images that represent cultural/ethnic 
diversity from our Real Health Photos stock art library, which improved message effectiveness. Focus 
groups will last approximately two hours and participants will be paid $50 for their time. 
      3C.5.2. Semi-Structured Interviews with Managers: Managers (n=10) in public organizations and 
private companies with outdoor workers will complete semi-structured interviews on SSW Works, 
culturally relevant content for Hispanic/African American workers, and overall content/features, 
including tailoring to stages in the diffusion process. Managers will be identified nationwide through 
professional associations (e.g., Moody Insurance Company, Baldwin HR Consulting, and North 
American Association of Transportation Safety and Health Officials [NAATSHO], and employers in our 
prior research. They will be sent a link to view SSW policy promotion materials for managers toolbox 
and SSW training and materials for employees (e.g., fact sheets, posters, newsletter articles, etc.). 
Managers will describe sun safety policies and standard operating procedures, employee sun safety 
practices, employee susceptibility to solar UV damage, benefits, harms, facilitators and barriers for sun 
safety on the job, if they would use on-demand VLE, how training will be used (e.g., individually or in 
groups), current LMS, if they would add SSW training to LMS (and preferred format), need for 
assessment in LMS, and how helpful SSW would be for their outdoor workers. These 1-hour interviews 
will be conducted by telephone by the Project Coordinator; participants will be paid $50 (unless public 
employees cannot accept financial compensation). 
Milestones & Deliverables: Milestone 2: Development of the Specifications Document: Qualitative 
analysis will rely on constant comparative analysis and methods by Krueger and Casey, assigning 
codes that categorize themes and opinions. A comprehensive specifications document describing the 
SSW Works will be developed from this analysis. This will include content changes to increase 
relevance and effectiveness with Hispanic and African American employees. Deliverable 2: 
Specifications Document for SSW Works. 
 
3C.6. Production of the Prototype SSW Works (Months 4-5) 
A prototype of SSW Works will be produced using agile, iterative production. Training/materials for 
employees will be revised to address facilitators/barriers identified by Hispanics and African Americans. 
We will create a staging algorithm on readiness to innovate in DIT, with input forms for managers to 
report their support for and actions on sun safety and tailored report template. A process for managing 
missing data will be established. The prototype will generate real-time, customized workplace SSW 
Report. We will also create a storyboard for one manager brief/video, list of tentative topics for 
employee skills videos and a storyboard for one of them. KB media developers will re-program the 
employee training to be compatible with a popular LMS by formatting files for specific requirements and 

ensuring SCORM-compliance. We will author a 15-item assessment of employee sun safety knowledge 
and skills for the LMS. KB media developers will add technical requirements to the specifications 
document and, along with investigators, determine how robust the prototype will be given 
budget/timeline to meet Phase I goals (i.e., demonstrate features and test elements users may have 
trouble using). Outlines, flow charts (i.e., wireframes), storyboards, and screen designs will be prepared 
as clickable wire-frame prototypes. The prototype will conform to the federal 508 standards for 
accessible information technology. 
Milestones & Deliverables: Milestone 3: Development of SSW Works Prototype: KB programmers will 
develop a prototype SSW Works in Months 4-5. A clickable wire-frame of tailoring algorithm, training 
conforming with an LMS, and storyboards of videos will be produced, with other materials in flowcharts. 
Deliverable 3: Revised Specifications Document for SSW Works. Deliverable 4: SSWWorks Prototype. 
 
3C.7. Evaluation of Prototype SSW Works Virtual Learning Environment (Months 6-7) 
      3C.7.1. Semi-structured Usability Interviews: The prototype SSW Works will be evaluated for 
feasibility, acceptability, and usability in semi-structured interviews with 10 managers and 20 Hispanic 
and African American workers (10 each) in Months 6-7 (those participating in prior Phase I research will 
be ineligible). To identify problems that impact >10% of users in usability testing with a 90% chance of 
detection (log(1-.90)/log(1-.10)), 21 participants are needed. We will create scenarios and tasks for 
using SSW Works, which will be given to participants who will review and interact with the 
flowcharts/storyboards/wire-frames, complete the System Usability Scale (SUS), and answer a set of 
interview questions. For workers, the tasks will focus primarily on completing the training and 
reading/reacting to the other promotional materials. They will evaluate perceived appropriateness and 
usefulness of content, if it is feasible to use SSW Works at their workplace, and potential barriers to 
use. Managers and workers will be paid $75.  
3C.7.2. Algorithm Testing: We will evaluate the tailoring algorithm in the following 4 steps, using 
the SSW Reports prepared for 21 state DOTs in our previous trial:  
1. Policy coding, manager survey, sun safety checklist, and SSW Report for 5 DOTs selected at 
random will be used to create the initial algorithm flowchart.  
2. Next, 5 DOTs will be selected at random and the algorithm will be trained by using policy 
coding, manager survey, and sun safety checklist to prepare a SSW Report using the algorithm 
flowchart. The report will be compared to the one created for DOTs and algorithm adjusted to 
resolve discrepancies.  
3. Refined algorithm flowchart will then create SSW Reports for another 5 DOTs selected at 
random and further refined to resolve remaining discrepancies with the original report.   
4. Finally, to measure feasibility and accuracy, the final algorithm flowchart will create the SSW 
Report for the last 6 DOTs and the number of discrepancies with the original reports will be 
recorded. 
3C.7.3. LMS Testing: We will identify 5 employers (compensation=$500) that use LMS for which 
training is programmed. KB media developers will work with employers’ IT staff to load the training into 
the LMS and confirm that it operates (e.g., collects registration; tracks completion; conducts 
assessment).  
Milestones & Deliverables: Milestone 4: Evaluation of the Prototype: Data will be stored in KB’s 
secure servers, with data management and analysis supervised by Dr. Cutter, Project Biostatistician 
and KB’s Biostatistical Manager, using quality assurance protocols and SAS software. Analyses of the 
SUS will include descriptive statistics; answers to interviews will rely on qualitative methods to code and 
categorize themes. In Month 9, reports will summarize findings from interviews and SUS on usability/ 
acceptability, discrepancies in algorithm-generated report, compatibility with LMS, and suggestions to 
improve it in Phase II research. Media developers will update specifications document for the full SSW 
Works in Phase II. Deliverable 5: Evaluation Reports. Deliverable 6: Further Revised Specifications 
Document. 
 
3C.8. Evaluation of Feasibility of SSW Works Virtual Learning Environment (Month 9) 
In Month 9, EAB will review Phase I findings and advise on feasibility of SSW Works, how to meet 
preferences of managers and workers, and methods for implementing and evaluating it in Phase II. 
Feasibility metrics include a) tailoring algorithm and training content being acceptable to ≥75% of 

managers and workers, b) specifications and prototype of MedTend being successfully developed, c) 
prototype being acceptable/usable to at least 75% of manager and workers (minimum score of 68 out 
of 100 on SUS), c) algorithm-generated report have <20% discrepancies, and d) training operating 
within LMS environment. If these feasibility metrics are not achieved, we will continue to iteratively 
refine SSW Works based on Phase I results, EAB input, and testing with more managers, employees, 
and employers until prototype is acceptable, receives a SUS score of ≥68, produces reports with <20% 
discrepancies, and operates on LMS. Given SSW was acceptable/effective in past research, likelihood 
of not achieving Phase I feasibility metrics is low. 
Milestones and Deliverables: Milestone 5: Feasibility Assessment: The EAB will review Phase I 
outcomes, advise on feasibility of full SSW Works, and provide input on final specifications document to 
guide Phase II production, if deemed feasible. Findings will be formalized into a final report on Phase I, 
including decision on feasibility of SSW Works and plans for Phase II development and research. 
Deliverable 8: Phase II Plan and Final Specifications Document. Deliverable 9: Final Report. 
 
3C.9. Scientific Rigor, Limitations, and Alternatives in Phase I Research  
State-of-the-art, pre-defined protocols, diverse samples, and established measures (e.g., SUS) will 
ensure scientific rigor of Phase I, which focuses on feasibility of SSW Works. The small samples in 
Phase I are typical for formative qualitative research. If recruitment of Hispanics and African Americans 
lags, we will also recruit them through KB’s staff in New Mexico and our professional networks in other 
states. 
 
3C.10. Overview of Phase II Research and Timeline 
SBIR Phase II research will include full production of SSW Works (Months 10-18) and a randomized 
controlled field trial testing its effectiveness (Months 15-36), in a 27-month timeline. The target 
population is employees and managers at employers with outdoor workforces. Media developers at 
Klein Buendel (KB) will produce the SSW Works, using Phase I specifications and prototype. The EAB 
will meet in Month 11 to approve protocols, in Month 17 to review fully-produced SSW Works, and in 
Month 36 to review trial outcomes. All Phase II procedures will be approved by the Western IRB. 
Employers participating in Phase I research will be ineligible for Phase II. 
 
3C.11. Full Production of SSW Works Virtual Learning Environment (Months 10-18)  
      3C.11.1. Iterative Production: SSW Works will be produced by KB’s Creative Team of a graphic 
designer and multimedia programmers, using KB’s agile, iterative development approach. Based on 
formative research, specifications document, and prototype from Phase I, we will finalize content, with 
cyclical review and feedback. All materials will be in both English and Spanish; Dr. Gonzalez (EAB) will 
review Spanish materials and Dr. Newton (EAB) the African American materials for cultural accuracy. 
The 30-minute online training can be viewed within the SSW Works or downloaded compatible with 
common LMS technologies. Interface design ideas with “timeless” language, graphics, and video 
depictions will be created and combined with scripts, flowcharts, and storyboards. Overall look and feel 
is consistent with Phase I prototype. Each component will be tested for platform stability/code errors 
prior to being exported to the Web server. After usability testing, SSW Works will be published to KB’s 
secure web server in Month 19. It will run on common web browsers for Mac OS X and Windows 
personal computers and on iOS and Android tablet computers and smartphones. It will be authored in a 
Responsive Web Design approach that optimizes user experience across platforms/screen sizes, using 
Angular, HTML5, CSS, JavaScript, and Microsoft dotNet platform (using C# language). Microsoft SQL 
databases will track use. KB’s media developers will maintain SSW Works, monitor usage, and provide 
technical support to users by email and toll-free phone number. 
      3C.11.2. Iterative Usability Testing: SSW Works will be usability tested in Month 16-17 with 
procedures from Phase I. Managers (n=10) meeting eligibility criteria will be recruited and consented 
(10 usability testers will identify 95% of problems; compensation=$75). Using protocol analysis, 
participants will talk aloud while navigating SSW Works, saying what they are thinking. Staff will record 
navigation and problems. Participants will complete SUS, and interview on usefulness/ appropriateness 
of content, feasibility at workplace (including in their LMS), and barriers to its use. Project staff will 
summarize results for investigators and KB media developers. Participants will be run in two rounds of 

5 participants, with revisions made between rounds to improve usability and produce the final SSW 
Works.  
Milestones and Deliverables: Milestone 6: Production of the SSW Works. Deliverable 10: Fully-
produced SSW Works. 
      3C.11.3. Limitations and Alternatives of the SSW Works VLE Development: We will use our 
experience with technology interventions and Phase I findings to design a usable, effective SSW Works 
meeting needs of employers and outdoor workers. KB developers will use up-to-date, cost-effective 
production software. Usability testing will ensure SSW Works is maximally user-friendly.  
 
3C.12. Randomized Trial (Months 15-36)  
A randomized trial will evaluate SSW Works on outdoor workers’ sun protection (primary outcome). 
Employers (n=20) will be recruited nationally and enrolled in a randomized, pretest-posttest controlled 
field trial. After baseline assessment of employees (n=50; compensation: $20) and managers (n=6; 
compensation: $25) in Months 15-18, employers will be stratified by expected probability of 
implementation based on a propensity score including size (number of employees), solar intensity 
(proxy for climate and UV), and urbanicity, and randomized to receive the SSW Works (n=10 
employers) or minimal information only (n=10 employers) by Dr. Cutter. These 3 variables were 
significant covariates in our past research44 or predicted baseline policy. We will then randomize within 
blocks of similar propensity scores to achieve comparable groups. A minimal information treatment, not 
the original SSW, will be the control condition because we do not expect SSW Works to be superior to 
SSW in effectiveness (our primary outcome) but rather more feasible and lower in cost. Intervention 
period will last 12-months – Months 19-30. Posttesting will be completed in Months 31-33 and data 
analysis by Month 36. Primary outcome will be assessed by surveying employees who work outdoors 
pre and post on sun protection practices. Workplace sun safety policy, education, and actions will be 
assessed pre and post by coding written policies (coders blind to condition) and surveying managers. 
Analyses will test the following hypotheses:  
H1: 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.  
H2: Improvements in employee sun safety will be mediated by workplaces adopting 
occupational sun safety policies and implementing education and actions on sun safety for 
employees. 
We will test a research question of whether use of the SSW Works improves employees’ sun 
protection. 
 
3C.13. Recruitment of Employers, Managers, and Employees 
Dr. Walkosz will lead recruitment using successful protocols from prior projects and approved by the 
Western IRB. We will identify eligible employers, working with industry professional associations and 
employers from GSS and SSW trials. Innovations such as SSW disseminate in societal sectors and 
professional associations create loose networks and intra-sector communication on emerging issues. 
We will recruit employers from diverse industries with outdoor workers (e.g., agriculture, oil/gas 
exploration, construction, utilities, transportation, outdoor recreation, public works, and public safety), 
from which we have recruited in the past. We obtained commitment from industry groups such as 
Moody Insurance Company, Baldwin HR Consulting, and NAATSHO to help us recruit employers, as 
well as from individual employers such as Eagle River Water and Sanitation. We do not want to bias 
our sample toward “compliant” employers who may already implement sun safety. Many employers are 
contending with the COVID-19 emergency as we finalized this application; requests for letters would 
have interfered with emergency responses. We are confident based on our 20 years of experience 
recruiting over 220 employers that these industry groups will help us recruit the needed employers. 
Employers with diverse employees (i.e., non-Hispanic white, Hispanic, and African American) will be 
recruited from the 4 U.S. Census regions to achieve diverse geography/climates that affects UV (UV is 
highest in low latitudes, high elevations, and dry climates), population density, and melanoma 
incidence. If recruitment lags, we will partner with additional industry associations. Employers will be 
stratified on size, solar intensity and urbanicity, randomly ordered within strata by Dr. Cutter, and 
contacted by project staff, from the top of list, by sending an invitation letter to the senior-most 

managers and following-up by email/telephone and replacing refusals with the next eligible 
organization. Employers will provide email, mail, and telephone contact information for eligible 
managers who will be invited to read a consent statement and complete a pretest. Managers will 
provide a list of eligible employees who work outdoors, and Dr. Cutter will select a random sample. We 
will send surveys with consent statement to employers to be distributed to the selected employees. 
Employees can complete the survey and return it in pre-paid envelopes or complete it online. At least 6 
managers and 50 employees need to complete the pretest for the employer to be eligible and 
randomized, so at least 5 managers and 35 employees will posttest. 
 
We will track and posttest all participants, including those who leave the workplaces, using our 
successful retention methods. At pretest, participants will give name, address, home, work and mobile 
phone numbers, and email address of a person who can locate them. For managers, persons in the 
positions sampled at pretest will be posttested (new position holders will be posttested; we will attempt 
to posttest original person). Invitations will be issued by email. Subsequent contact attempts will be 
adjusted to maximize completion by non-responders and key ethnic minority groups (e.g., frequency, 
mode [email, U.S. mail, and telephone], and location). To reach persistent non-responders, staff will 
visit workplaces and complete survey in person and/or send non-respondents printed and PDF copies 
of posttests by mail (with a stamped return envelope) and email. We have recruited and retained large 
manager/employee samples using similar methods. 
 
3C.14. Implementation of the SSW Works  
SSW Works will be launched in Month 18 on KB’s state-of-the-art web server. Extensive usability 
testing/refinement and tailoring to employer will increase user engagement (fidelity). We will send email 
invitations and monthly reminders to use SSW Works, tailored for season and UV levels and stressing 
partnerships with industry groups.  
 
3C.15. Minimal Information Control Condition  
As in our SSW trial, 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.  
 
3C.16. Measures 
 
3C.16.1. Primary Outcome Measure: Employees Sun Protection Practices: Employees will 
report a) 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]) and b) prevalence of sunburn in past 3 months on 
the job (yes/no; number). SPF 30+ is advised in SSW to account for typical under-application that 
reduces effective SPF. The measures are standard, validated, and reliable and were used in our GSS 
and SSW trials. 
 
3C.16.2. Intervention Process Measures: With its automation, fidelity is indicated by use of SSW 
Works, recorded with process measures. Managers will log on to SSW Works, using project-supplied 
IDs; database will record use of features (i.e., sessions, pages viewed, and time spent) and b) use of 
sun safety training recorded on LMS. Mailing of printed materials will be recorded in minimal 
information control. 
 
3C.16.3. Measures of Policy, Education, and Sun Safety Actions: We will assess 
implementation of sun protection policy, education, and sun safety actions by coding written workplace 
policies and surveying managers. A composite score will assess presence, strength, intent, and 
responsibility in sun protection policies using a protocol developed in the SSW trial assessing 15 policy 
categories: engineering controls (physical environment of the workplace), administrative controls 
(workplace procedures), and employee education (workers’ sun safety). Each category receives a point 
(0, 1) for presence (total score=15) and a 3-level strength score (0=not allow/specify, 
1=allow/recommend, 2=require; total score=30). Policies on engineering controls (scheduling/shade) 
and sun safety practices (hats/protective clothing) could exist for other reasons (e.g., to prevent injury), 
so those categories receive a point (0,1) when sun protection is cited. A 3-level responsibility score is 

assigned for who provides protection equipment (0=not specified, 1=employee, 2=employer). Ordinal 
composite scores are continuous and summed across categories. Human resources and safety 
documents will be excerpted and coded by trained research assistants (blind to condition). Inter-coder 
reliability will be checked at the beginning, middle and end to ensure it remains high (>0.70). There is 
no basis for the minimum number of components that must be changed to improve workplace sun 
safety, so we will assess both presence and extent of change, which can detect expansion of existing 
policies.  
 
Managers will report on sun safety education and workplace actions to support sun safety. 
Managers will report if training was provided to employees, and to supervisors and managers 
(yes/no/don’t know). They will report on eight sun protection actions in the workplace: 1) Employer 
monitors UV Index and work scheduled is adjusted for harm associated with UV level; 2) Employees 
wear PPE (i.e., sun protective clothing, hats, and eyewear; sunscreen with SPF 30 or higher); 3) 
Employer provides PPE (i.e., gives sunscreen, protective clothing, or eyewear or money to buy them); 
4) Employer provides temporary/permanent shade structures in work environment; 5) Employer 
communicates messages to employees about sun protection; 6) Employer requests 
contractor/subcontractor employees comply with worksites’ sun safety policy; 7) Employees are 
encouraged to regularly check skin for signs of skin cancer by themselves or physician; 8) Employer 
conducts a risk assessment of sun exposure and sun protection for employees. This self-report 
measure was modified from a study on implementation of school sun protection policies.  
 
We will also measure two ancillary policy outcomes in manager surveys with items from past SSW 
trials: Unwritten informal standard operating procedures on sun safety (i.e., presence and content of 
procedures) and enforcement of sun protection policies (i.e., how well is policy being implemented and 
how well are staff complying with policy [very well, well, about average, poorly, or very poorly]). 
 
3C.16.4. Measures of Potential Effect Moderator: Potential effect moderators include those 
suggested by Diffusion of Innovations Theory and Bingham’s model of innovation. Standard published 
measures will be used (cited below); psychometric analysis will be conducted on new items 
(reliability>0.60).  
• 
Organizational factors: size (i.e., number of employees), employer type, job type, number of 
female managers, and annual operating budgets (to assess slack resources) (all reported by 
employers).  
• 
Community characteristics: size (population), education, affluence (from the U.S. Census) 
and mean annual hours of sunshine (from National Weather Service; used to stratify the 
sample).  
• 
Manager and employee characteristics: skin cancer history (doctor told you that you had skin 
cancer [yes/no; type]); skin sun sensitivity (always burn, unable to tan/usually burn but can tan if 
try/sometimes mildly burns, tan easily/rarely burn, tans easily); job characteristics (years 
working in industry, job title, work mostly outside/mostly inside/outside and inside equally) and 
demographics (age, sex, education, race, Hispanicity, marital status, children in home) from our 
GSS trials; opinion leadership (validated scale, reliability α=0.86; managers only); 
innovativeness (validated scale; reliability α=0.94; managers only)230; and readership of 
professional publication (managers only).  
 
3C.16.5. Data Collection and Management Procedures: Surveys of employees and managers 
will be conducted online and by mail. Managers will receive email invitations, with link to online survey 
in KB’s Qualtrics software on a secure web server (5 email reminders at 7-day intervals). Employees 
will be sent printed surveys (with postage-paid return envelopes) and a link to online survey and receive 
a sunscreen lip balm for completing. All answers are confidential and not revealed to co-workers, 
superiors, or subordinates. Participants will provide name, address, home and mobile phone numbers, 
and email address of a person who can always locate them. All forms/procedures will be approved by 
the Western IRB. We had high completion in our SSW trials. Employees will be sampled at pretest from 
employee rolls; we will track and posttest all employees pretested, including those who leave. 
Managers will be sampled by position at pretest and persons in same positions will be posttested (new 
position holders surveyed and original person tracked and posttested). Multiple survey modes have 
improved retention to eliminate non-response biases. To reduce multi-mode differences, we will follow 
Dillman a) response options are identical, b) question structure/response labels are invariant, c) skip 
patterns are same, d) unfolding questions are avoided, and e) response categories are reversed. 

Multiple modes introduce very small differences (eliminated by demographic controls) that do not affect 
relationships between variables. For policy collection, staff will request managers send workplace 
safety/health policy documents; staff will check employers’ websites. 
• 
Data management will be performed by KB’s data managers using well-established 
procedures. Missing responses will be checked to ensure they were not intentionally skipped. A 
random sample of 10% of manually-entered forms will be double entered; if error rate exceeds 
1%, all forms will be double entered. Sophisticated editing/quality assurance procedures (e.g., 
manual and computerized audits) will be implemented. SAS software (V9.3 or higher) will be 
used in analyses. Analyses will be done on data collected (case-wise deletion) and by 
imputation for missing data. We will estimate effect of missing-ness by assigning all lost 
individuals to an extreme category, in either direction. We will perform imputation utilizing 
Markov Chain Monte Carlo – Data Augmentation Method in SAS PROC MI, and use a variety of 
covariates and propensity scores. 
 
 
 
 
 
 
 

Statistical Analysis Plan 
 
4.3 Statistical Design and Power 
4.3.1. Descriptive and Exploratory Analyses: Simple descriptive analyses (e.g., frequencies, means, 
standard deviations, etc.) on employee and employer characteristics and outcome will be calculated. 
Propensity scores will be calculated before randomization and distribution examined. Given the sample 
size of worksites, we do not think inverse probability weighting will be necessary but will look for outliers 
in propensity score distribution to guide sensitivity analyses. After randomization, descriptive analyses 
by treatment group will be 
conducted, using bivariate analyses (e.g., t-tests, χ2) to identify unexpected differences at baseline. 
Those with differences exceeding 0.25 SD will be treated as covariates in sensitivity analyses to assess 
their impact on conclusions. Analyses will use intention-to-treat with sensitivity analyses. All analyses 
will be performed using SAS 9.4, using a 2-tailed p=.0.05. 
 
4.3.2. Primary Outcome Analysis – H1: Improvement in Employee Sun Protection: Primary 
analysis will test hypothesis that compared to employers in minimal information control, employers 
receiving the SSW Works will have employees who practice more sun protection at posttest. Employee 
sun protection (ordinal summed frequency score) and history of sunburn (yes/no; number) will be 
analyzed using a mixed effects model, a variation of hierarchical linear modeling, in SAS PROC 
GLIMMIX using a binomial covariate, experimental group (i.e., SSW Works v. control) as a fixed effect, 
and testing period as a repeated factor, adjusting for intraclass correlation (ICC) among employees 
within worksite to avoid inflating Type I error. 
Changes at posttest between groups and within intervention group will be examined. 
 
4.3.3. Secondary Analyses of Mediation – RQ: Association of Use of SSW Works with 
Employee Sun Protection: We will explore mediation by program exposure assessed by process 
measures, using mediational analyses from Judd and Kenny and elaborated by MacKinnon. To satisfy 
the conclusion of mediation, significance will be determined via interval estimation using a bootstrap 
estimate. Ratio of indirect to total effect will estimate proportion of effect mediated by engagement. 
 
4.3.4. Secondary Analyses of Mediation – H2: Association of Occupational Sun Protection 
Policies/Actions with Employee Sun Protection: H2 predicts SSWWorks will improve employees’ 
sun protection by increasing workplace policies, education, and actions. Separate ordinal scores will be 
calculated for policy content/strength, education, and actions. Using our nested models to account for 
differential numbers of respondents by employer, we will test them as mediators of the impact of 
SSWWorks on employee sun protection, using regression techniques from Judd and Kenny and 
MacKinnon, testing significance of 
mediation via interval estimation using a bootstrap estimate of the variation and estimating proportion of 
effect mediated with ratio of indirect to total effects, as above 
. 
4.3.5. Ancillary Tests of Moderators: Stratifying variables (i.e., size; region; urbanicity) and potential 
moderators (i.e., organizational factors; community characteristics; manager and employee 
race/ethnicity and other characteristics), including employee sex, will be tested for representativeness 
of SSW Works effects. Added as fixed effects, interactions with experimental condition will be examined 
at p=.05 (2-tailed), unadjusted for multiple comparisons. 
 
4.3.6. Statistical Power: In our previous SSW trial, employees in the SSW group reported higher 
composite sun protection on the job than in the control group (mean=3.46 [sd=0.05] v. 3.34 [sd=0.05]). 
Using these standard deviation (sd) estimates in a cluster randomized trial with n=20 employers (10 per 
group) and assuming the ICC is as much as 0.01, the power is over 99% for detecting differences on 
this composite score of 0.02 (H1) with a sample of 35 employees per worksite evaluated at posttest. 
Similarly, in the prior trial, sun safety policy, education, and actions predicted higher employee sun 
safety: The composite score was higher at employers with a policy than without (mean=3.46 v. 3.34, 
p=0.006) and SSW’s effect on the composite score was mediated by implementation of more sun 

safety training (proportion mediated=37.6%, p=0.035) and actions (observed messages and PPE, 
proportion mediated=26.4, p=0.041). With this level of proportion mediated, we will have sufficient 
power (>90%) to identify a positive level of mediation (H2) with 35 employees per worksite at posttest. 
Adjusting for a retention rate of at least 70% at follow-up, we will sample 50 employees per worksite for 
the baseline survey, expecting 35 per worksite to complete the posttest.