A Randomized Control Trial of Sun Protection Interventions for Operating Engineers

Skin Cancer Prevention Clinical Trial

Official title:

A Randomized Control Trial of Sun Protection Interventions for Operating Engineers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01804595
• Other study ID #: N015454-00
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 26, 2013
• Last updated: May 19, 2014
• Start date: February 2012
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Skin Cancer Prevention

Intervention

Other:
• Sunscreen

Behavioral:
• Text-Message Reminders

Other:
• Sunscreen and Text Message Reminders

Behavioral:
• Education

Locations

Country	Name	City	State
United States	University of Michigan School of Nursing	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Blue Cross Blue Shield of Michigan Foundation

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sunscreen use	Subjects will complete a baseline survey during safety training sessions in Winter when they get the educational intervention. In the past summer, on the days when you were outside in the sunlight, how often did you use sun block (never, some of the time, about half the time, most of the time, always)?	Baseline	No
Primary	Sun Burning	Subjects will complete a baseline survey during safety training sessions in Winter when they get the educational intervention. On average, how many times did you get a sunburn this past summer (0, 1, 2, 3, 4 or more times)?	Baseline	No
Primary	Sunscreen use	Subjects will be texted or phoned this question monthly during the intervention period and will again receive this question on the longer follow up survey up to 5 months after the interventions end. In the past summer, on the days when you were outside in the sunlight, how often did you use sun block (never, some of the time, about half the time, most of the time, always)?	Post-intervention	No
Primary	Sun Burning	Subjects will be texted or phoned this question monthly during the intervention period and will again receive this question on the longer follow up survey up to 5 months after the interventions end. On average, how many times did you get a sunburn this past summer(0, 1, 2, 3, 4 or more times)?	Post-intervention	No

External Links

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