A Randomized Control Trial of Sun Protection Interventions for Operating Engineers

NCT ID: NCT01804595

Last Updated: 2014-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 357 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-12-31

Brief Summary

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.

Detailed 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.

Conditions

Skin Cancer Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Sunscreen

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.

Group Type: EXPERIMENTAL

Sunscreen

Intervention Type: OTHER

Education

Intervention Type: BEHAVIORAL

Text Message Reminders

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!").

Group Type: EXPERIMENTAL

Text-Message Reminders

Intervention Type: BEHAVIORAL

Education

Intervention Type: BEHAVIORAL

Sunscreen and Text Message Reminders

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.

Group Type: EXPERIMENTAL

Sunscreen

Intervention Type: OTHER

Text-Message Reminders

Intervention Type: BEHAVIORAL

Sunscreen and Text Message Reminders

Intervention Type: OTHER

Education

Intervention Type: BEHAVIORAL

Education

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.

Group Type: ACTIVE_COMPARATOR

Education

Intervention Type: BEHAVIORAL

Interventions

Sunscreen

Intervention Type: OTHER

Text-Message Reminders

Intervention Type: BEHAVIORAL

Sunscreen and Text Message Reminders

Intervention Type: OTHER

Education

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Blue Cross Blue Shield of Michigan Foundation

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Sonia Duffy

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sonia A Duffy, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan School of Nursing

Ann Arbor, Michigan, United States

Countries

United States

References

Walkosz BJ, Buller DB, Andersen PA, Scott MD, Dignan MB, Cutter GR, Maloy JA. Increasing sun protection in winter outdoor recreation a theory-based health communication program. Am J Prev Med. 2008 Jun;34(6):502-9. doi: 10.1016/j.amepre.2008.02.011.

Reference Type: BACKGROUND

PMID: 18471586 (View on PubMed)

Armstrong AW, Watson AJ, Makredes M, Frangos JE, Kimball AB, Kvedar JC. Text-message reminders to improve sunscreen use: a randomized, controlled trial using electronic monitoring. Arch Dermatol. 2009 Nov;145(11):1230-6. doi: 10.1001/archdermatol.2009.269.

Reference Type: BACKGROUND

PMID: 19917951 (View on PubMed)

Duffy SA, Ronis DL, Waltje AH, Choi SH. Protocol of a randomized controlled trial of sun protection interventions for operating engineers. BMC Public Health. 2013 Mar 26;13:273. doi: 10.1186/1471-2458-13-273.

Reference Type: DERIVED

PMID: 23530608 (View on PubMed)

Related Links

http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandingover-the-countermedicines/ucm258468.htm

FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S. 2011

Other Identifiers

N015454-00

Identifier Type: -

Identifier Source: org_study_id