A Randomized Control Trial of Sun Protection Interventions for Operating Engineers

University of Michigan

Status and phase: Completed; Phase 3; Phase 2

Conditions: Skin Cancer Prevention

Treatments: Other: Sunscreen; Behavioral: Education; Other: Sunscreen and Text Message Reminders; Behavioral: Text-Message Reminders

Study type: Interventional

Funder types: Other

Identifiers

NCT01804595

N015454-00

Details and patient eligibility

About

This is a randomized controlled trial testing the efficacy of 4 sun protection interventions--education only; education and mailed sunscreen; education and text message reminders; and education, mailed sunscreen, and text message reminders--among Michigan Operating Engineers. Pre- and post-intervention surveys will be collected to determine changes in sunscreen use and sun burning, the primary outcome variables. The investigators hypothesize that all interventions will increase sunscreen use and reduce burning and that the education-only intervention will have the least effect of the 4 interventions while the education, mailed sunscreen, and text messaging arm will have the greatest effect.

Full description

The education intervention will be provided during regularly scheduled safety training sessions, and the text messages and mailed sun screen (SPF30)interventions will be offered during the summer when UV rays are at their highest. Inclusion criteria are Operating Engineers who:1)are greater than 18 years of age; 2) are interested in enrolling in the sun protection study; 3) own a cell-phone that accepts text messages; and 4) are willing to share their phone number with the study team. Based on power analysis, 256 subjects are needed to have 80% power to detect medium sized effects on primary outcomes. Accounting for a 20% attrition rate, 320 subjects will be recruited. The analyses will include: a) paired t-tests to determine changes over time (from pre-intervention to post-intervention) in outcome variables (sunscreen use and burning) separately in the 4 intervention groups, b) Repeated Measures Analysis of Variance (RM-ANOVA) to compare the changes in outcomes across the 4 groups, and c) t-tests on change scores as follow-ups to the RM-ANOVA to determine exactly which groups differ from each other. Sub-analyses will explore if particular subgroups of Operating Engineers (e.g., demographic, heath behavior, and job type subgroups) differ in sunscreen use and sun burning pre-and post-intervention.

Enrollment: 357 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• greater than 18 years of age
• interested in enrolling in the sun protection study
• owning a cell-phone that accepts text messages
• willing to share their phone number with the study team

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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357 participants in 4 patient groups

Sunscreen

Experimental group

Description:

To reduce barriers to obtaining sunscreen and serve as cues to action, this group will be mailed during the months of May through September, a supply of SPF30 sunscreen lotion (known to prevent sun burning and skin cancer). The mailing will consist of large bottles of sunscreen and a small bottle that can be refilled and attached to their huge key rings that hang off of their belts.

Treatment:

Behavioral: Education

Other: Sunscreen

Text Message Reminders

Experimental group

Description:

As cues to action, this group will receive 60 cellular telephone text-messages on three random mornings per week during the month of May, June, July, August, and September when UV rays are the highest. Using an internet text-messaging service, the messages will be computer generated and sent to Operating Engineers and contain information about weather conditions and various reminders (e.g., "Put on sunscreen today" or "Wow, it's a hot one, you know what to do!").

Treatment:

Behavioral: Education

Behavioral: Text-Message Reminders

Sunscreen and Text Message Reminders

Experimental group

Description:

Just as multimodal interventions such as surgery and radiation can be used to treat skin cancer, multimodal behavioral interventions may reduce sun burning and prevent skin cancer. To determine if the combination of these interventional components results in improvements above and beyond the individual parts, both sunscreen and text messaging interventions will be provided in addition to education.

Treatment:

Behavioral: Education

Other: Sunscreen

Other: Sunscreen and Text Message Reminders

Behavioral: Text-Message Reminders

Education

Active Comparator group

Description:

A 30-minute, picture enhanced power point presentation will be offered to all Operating Engineers during their annual safety trainings. The content of the power point presentation will include information on incidence and prevalence of skin cancer especially among outdoor workers, types of skin cancers and skin cancer risk, sunburn, Sun Protection Factor (SPF), sun protection behaviors including sunscreen use, correct application of sunscreen, types of products, and the new Food and Drug Administration (FDA) labeling of sunscreen products. In addition, other sun protection behaviors such as wearing hats, sunglasses, using shade, etc., will be discussed.

Treatment:

Behavioral: Education