NCT03278340

Brief Summary

Comprehensive approaches that combine sun protection policy and education for outdoor workers can reduce their risk for skin cancer by reducing their exposure to solar ultraviolet radiation on the job. To effectively disseminate the investigators' evidence-based sun protection policy and education intervention, Sun Safe Workplaces, a balance of effectiveness and cost of scale-up methods is required. The investigators propose to translate the intervention using a technology-based delivery method and compare the cost effectiveness of the original intervention and the intervention delivered by technology in a study that models national distribution strategies to public safety and public works sectors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,644

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

July 14, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

7 years

First QC Date

September 6, 2017

Last Update Submit

November 12, 2024

Conditions

Keywords

Skin CancerPreventionPolicyWorksiteScale-upCost and Effectiveness

Outcome Measures

Primary Outcomes (2)

  • Implementation of Occupational Sun Protection Policy

    Policies will be collected from work sites and coded at both before and after the intervention period. Project staff will code written workplace policy documents on the presence of 15 "content categories" in three domains: 1) environmental controls; 2) administrative procedures; and 3) personal protection practices. Presence of policy is defined as having one or more policy components present in the written workplace policy documents (value = 1) versus no content components present (value = 0).

    Baseline to 2 years followup

  • Implementation of Sun Safety Education

    Senior managers and employees will report on sun safety education provided to employees. The primary measure will be managers' reports of any training or any sun safety messages/materials distributed (e.g., newsletter articles, SSW website, or emails). Employees' reports of sun safety education will be secondary, validating managers' reports. These measures will be obtained in senior manager and employee pretest and posttest surveys, conducted online and by mail

    Baseline to 2 year followup

Secondary Outcomes (4)

  • Economic Evaluation of the SSW-IP and SSW-T Intervention Programs

    Baseline to 2 year followup

  • Changes in Workplace Environment for Sun Safety

    Baseline to 2 year followup

  • Other Policy-related Measures

    Baseline to 2 year followup

  • Employees Sun Protection Practices

    Baseline to 2 year followup

Study Arms (2)

Sun Safe Workplaces - Technology (SSW-T)

EXPERIMENTAL

Program promoting the adoption of sun protection policies by fire departments and state Departments of Transportation that is delivered via a range of technology systems including web-enabled visits with senior managers, online training of outdoor workers, and online access to collateral materials (e.g., brochures, posters, tip cards).

Behavioral: Sun Safe Workplaces - Technology

Sun Safe Workplaces - In Person (SSW-IP)

ACTIVE COMPARATOR

Program promoting the adoption of sun protection policies by fire departments and state Departments of Transportation that is delivered via personal visits with senior managers and in person training of outdoor workers by research staff over two years. Collateral materials (e.g., brochures, posters, tip cards) will be provided to worksites.

Behavioral: Sun Safe Workplaces -In Person

Interventions

After randomization, program staff will contact managers at the recruited employer and schedule the initial web-enabled visit in the first 6 months. Follow-up meetings will be scheduled as needed to discuss policy adoption, and managers will schedule employee education using the SSW-T online training. Staff will follow-up with managers through Month 34 (Wave 1) or Month 46 (Wave 2). Electronic materials will be published on KB's state-of-the-art web server for employers to access and use.

Also known as: SSW-T
Sun Safe Workplaces - Technology (SSW-T)

After randomization, program staff will contact managers the recruited employer and schedule the initial in-person visit in the first 6 months. Follow-up meetings will be scheduled as needed to discuss policy adoption; managers will schedule employee education with SSW-IP project staff. Printed materials will be sent to SSW-IP employers 3 times during the intervention. Staff will follow-up with managers through Month 34 (Wave 1) or Month 46 (Wave 2).

Also known as: SSW-IP
Sun Safe Workplaces - In Person (SSW-IP)

Eligibility Criteria

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

You may qualify if:

  • Fire Departments and State DOTs in the United States, agreeing to participate, providing written policies at pretest and having at least 6 managers and 50 workers complete the pretest.
  • Being a senior manager of a fire department or state DOT located in the United States. Criteria include a) being in a senior management position; b) responsible for work-site safety/health policy and education; c) consenting to participate, and d) completing the pretest. This includes city/county managers, human resources directors, risk managers, and managers of facilities, fire, roads and transportation departments
  • Being an employee of a fire department or state DOT located in the United States. Criteria includes a) being employed part/full-time at the employer, b) working at least part of daytime hours outdoors, c) consenting to participate, and d) completing the pretest survey.

You may not qualify if:

  • Prior participation in the Sun Safe Workplaces program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kaiser Foundation Research Institute

Oakland, California, 94612-3466, United States

Location

Klein Buendel, Inc.

Golden, Colorado, 80403, United States

Location

Related Publications (1)

  • Buller DB, Buller MK, Meenan R, Cutter GR, Berteletti J, Eye R, Walkosz BJ, Pagoto S. Design and baseline data of a randomized trial comparing two methods for scaling-up an occupational sun protection intervention. Contemp Clin Trials. 2020 Oct;97:106147. doi: 10.1016/j.cct.2020.106147. Epub 2020 Sep 15.

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • David Buller, PhD

    Klein Buendel, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not be aware of the condition in which their organization is assigned.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2017

First Posted

September 11, 2017

Study Start

July 14, 2017

Primary Completion

July 1, 2024

Study Completion

July 31, 2024

Last Updated

November 14, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations