NCT05774600

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
543

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2025

Completed
7 months until next milestone

Results Posted

Study results publicly available

March 19, 2026

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

February 9, 2023

Results QC Date

February 19, 2026

Last Update Submit

March 17, 2026

Conditions

Occupational ExposureSkin Cancer

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline assessment, 1 year assessment

  • Percentage Change From Baseline Employee Sunburn Prevalence at 1 Year

    The percentage change in employees reporting any sunburn in the last 3 months on the job from pretest to posttest.

    Baseline assessment, 1 year assessment

Study Arms (2)

SSW Works

EXPERIMENTAL

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.

Behavioral: SSW Works

Minimal Information Control

ACTIVE COMPARATOR

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.

Behavioral: Minimal Information Control

Interventions

SSW WorksBEHAVIORAL

SSW Works is a behavioral, culturally tailored online intervention for skin cancer prevention amongst outdoor workers in the United States.

SSW Works
Minimal Information ControlBEHAVIORAL

Provision of online materials for skin cancer prevention.

Minimal Information Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • Read a language other than English or Spanish
  • Read a language other than English or Spanish
  • Work exclusively indoors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klein Buendel

Golden, Colorado, 80401, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Mary Buller
Organization
Klein Buendel, Inc.
mbuller@kleinbuendel.com
720-350-8988

Study Officials

  • Mary Buller, MA

    Klein Buendel, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2023

First Posted

March 17, 2023

Study Start

June 1, 2023

Primary Completion

February 25, 2025

Study Completion

August 28, 2025

Last Updated

March 19, 2026

Results First Posted

March 19, 2026

Record last verified: 2026-03

Locations

US(1)