An interventional study of Sun Safe Workplaces - Technology and Sun Safe Workplaces -In Person in Skin Cancer, sponsored by Klein Buendel, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by Klein Buendel, Inc. · Not applicable, Interventional, and Prevention
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Among 380 studies in Skin Neoplasms with a site in United States — 63 open to participants now, 97 under way, 7 of them phase 3. Skin Neoplasms · United States.
Among the 380 studies in Skin Neoplasms with a site in United States, this one is the 6th largest by enrollment of the 289 interventional ones that give a count, is one of 16 that started in 2017, is one of 96 with no phase, and was the 206th registered.
605 studies on the registry are indexed under Skin Neoplasms; 127 are open to participants now.
Browse Skin Neoplasms studies →63 of the 380 studies in Skin Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Vanderbilt-Ingram Cancer Center · Sites in United States
Ages 18+
Rutgers, The State University of New Jersey · Sites in United States
Ages 13+ · Healthy volunteers
University of Utah · Sites in United States
Ages 18–29 · Healthy volunteers
Marissa Lobl · Sites in United States
Ages 18+
Dana-Farber Cancer Institute · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 105 Skin Neoplasms studies recruiting now, 85 (81%) set no upper age limit and 9 (9%) stop at 75 or younger; 15 take children under 18; 25 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
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380 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 84 · Phase 2 115 · Phase 3 26 · Phase 4 11
First in 1977; this study’s year is marked. 16 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 2,644 is above the median of 55 across 409 interventional studies indexed under Skin Neoplasms.
Median enrollment 43 across the 289 interventional studies, 149 across the 80 observational. Of the 258 that completed or were terminated, 92 (36%) have results posted.
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107 of 380 have an industry lead sponsor. The 10 most frequent:
Klein Buendel, Inc. is the lead sponsor of 35 studies on the registry; 2 are open to participants now.
Klein Buendel, Inc. has 9 studies filed under Skin Neoplasms — fewer than ten, so there is no comparison to draw.
34 of the studies in Skin Neoplasms with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05608291Phase 3Regeneron PharmaceuticalsA Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery | 2027-01-15 |
| NCT06947928Phase 3TuHURA Biosciences, Inc.Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma | 2027-03-31 |
| NCT05634252Phase 3University of UtahUndergraduate Skin Cancer Prevention Trial | 2027-09-04 |
| NCT07931664The Center for Clinical and Cosmetic ResearchEvaluating Photodynamic Therapy Used to Treat Cutaneous Squamous Cell Carcinoma in Situ (isSCC) on the Face, Upper Extremities & Trunk. | 2026-11 |
| NCT07201376Dartmouth-Hitchcock Medical CenterAssessment of Skin Lesions Using a Tissue Oxygen Imager Based on Protoporphyrin IX (PPIX) Fluorescence. This is an Open-label, Non-randomized, Feasibility Study That Includes a One-time Application of an FDA Approved Medication Followed by Local Imaging for Benign Skin Growth and Lesions Clinically | 2026-11 |
Add all 34 to your calendar (.ics) → With an account.
Among the 380 studies in Skin Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
A key goal in the Affordable Care Act is building a national culture of prevention through workplace health and safety initiatives. To achieve this goal, methods for scaling up evidence-based programs from research to wide-scale dissemination are needed to help balance effectiveness and cost. In many cases, there are pressures to reduce scale-up costs but at the expense of lower program implementation and effectiveness. A scale-up method that sacrifices effectiveness but reduces costs and reaches a larger number of employers may be acceptable. The investigators will model the effectiveness and cost trade-off, along with the extent and representativeness of reach, when scaling up the evidence-based occupational sun protection intervention, Sun Safe Workplaces (SSW), for national distribution. The intervention, which relies on personal contact with managers and in-person employee training (SSW-IP), created large improvements in comprehensive workplace sun safety (i.e., policy adoption and employee education) in a randomized controlled trial. The investigators will compare the existing in-person program delivery methods (SSW-IP) to a lower-cost dissemination method that utilizes Internet technology (SSW-T), i.e., virtual meetings, social networking, online training, and program materials. The aims of the research are to: 1) estimate the program reach (number and representativeness) and implementation rates (i.e., adoption of policies and delivery of education on occupational sun protection) achieved by the SSW-IP and SSW-T in a model of national distribution to public safety and public works industries; 2) estimate the costs associated with the SSW-IP and SSW-T (i.e., intervention costs and induced employer costs) and compare the estimated program benefits (i.e., policy and education) to cost; and 3) estimate the effect and cost-effectiveness of SSW-IP and SSW-T in secondary outcomes of a) changes in workplace environments and procedures for sun safety and b) workers' sun safety practices. In a 5-year project, SSW-T will be created by redesigning the very effective SSW-IP methods to use the latest web conferencing, social networking, and online training technology for dissemination. The implementation rates (defined as policy adoption and education delivery) and costs associated with SSW-IP (n=50 employers) and SSW-T (n=150 employers) will be modeled in a randomized two-group pretest-posttest design, enrolling a national sample of 200 employers (i.e., firefighting departments and state departments of transportation). Unlike traditional randomized trials, the primary analysis will be of cost effectiveness to test the hypothesis that SSW-T can be delivered cost-effectively to an expanded group of worksites producing a lower implementation rate than SSW-IP but at substantially lower cost. Secondary analyses will compare the two scale-up strategies on implementation rate, differences in rate by employer groups (e.g., size and region), changes to workplace environment/procedures, and employee sun safety practices. The findings will have high impact by helping public health practitioners select the best strategy for scaling up evidence-based workplace health and safety programs to achieve this ACA goal.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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
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
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).
Time frame: 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
Time frame: Baseline to 2 year followup
Economic Evaluation of the SSW-IP and SSW-T Intervention Programs
Project staff will record costs associated with the SSW-IP and SSW-T, following protocols from prior projects. Project staff will identify resource allocations and both labor and non labor elements for each component of the SSW-IP and SSW-T (in-person and virtual visits; follow-up communications; staff-delivered and virtual training, web resources, and mailed materials). For personnel, the proportion of FTE across activities will be estimated by contemporaneous staff self-report. Senior manager and employee survey data will identify organizational changes induced by SSW-IP and SSW-T and attach cost estimates to each. The investigators will use the accounting systems of the trial itself, supplemented with survey responses and additional primary data collection or external sources. Costs will be recorded in custom-made spreadsheets and summed to produce overall cost estimates.
Time frame: Baseline to 2 year followup
Changes in Workplace Environment for Sun Safety
Managers will report changes in the work environments (providing shade and adjusting outdoor work schedules) or procedures (risk assessment, posting UV Index, and providing sunscreen, hats, protective clothing, and sunglasses) for sun safety. To validate, trained staff (blind to condition) will visit 18 randomly-selected employers at post-test and record shade, posting of UV Index, sunscreen availability, employee clothing, hats, and sunglasses, and educational materials, using a protocol from our Go Sun Smart trial.
Time frame: Baseline to 2 year followup
Other Policy-related Measures
The investigators will measure two ancillary policy outcomes in the senior manager surveys, the content of informal procedures (not written) and enforcement of any sun protection policies (i.e., how well is policy being implemented and how well are staff complying with policy \[very well, well, about average, poorly, or very poorly\]).
Time frame: Baseline to 2 year followup
Employees Sun Protection Practices
Employees will report a) frequency of sun protection at work, i.e., sunscreen with SPF 15+, long-sleeved shirts, long pants, hat with brim, sunglasses, shade use, limit exposure to midday sun, and have sunscreen, hat and eye protection at all times (1=never, 5=always) and b) prevalence of sunburn in the past three months on the job (yes/no; number of times) from SSW and GSS trials. These are standard, validated, and reliable measures from past studies.
Time frame: Baseline to 2 year followup
Plan to share: No
Ran from Jul 2017 to primary completion in Jul 2024, 83 months.
Of 116 interventional studies with no phase under Skin Neoplasms, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 66. This study's 83 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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