Skin Cancer PreventionPhase 2/3NCT01804595
A Randomized Control Trial of Sun Protection Interventions for Operating Engineers
A Phase 2/3 study testing Sunscreen, Text-Message Reminders and Sunscreen and Text Message Reminders in people with Skin Cancer Prevention, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer Prevention
- What is being tested?
- Sunscreen, Text-Message Reminders and Sunscreen and Text Message Reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Nursing
Ann Arbor, Michigan, 48109
About this study
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.
Read the 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
- Being tested
- Sunscreen, Text-Message Reminders, Sunscreen and Text Message Reminders, Education
- Keywords
- Worksite intervention, Sun protection intervention, Operating Engineers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunscreenOther
Text-Message RemindersBehavioural
Sunscreen and Text Message RemindersOther
EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Sunscreen | Experimental | 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. Receives: Other: Sunscreen; Behavioral: Education |
| Text Message Reminders | Experimental | 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!"). Receives: Behavioral: Text-Message Reminders; Behavioral: Education |
| Sunscreen and Text Message Reminders | Experimental | 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. Receives: Other: Sunscreen; Behavioral: Text-Message Reminders; Other: Sunscreen and Text Message Reminders; Behavioral: Education |
| Education | Active comparator | 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. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)?
Measured: Baseline
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)?
Measured: Baseline
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)?
Measured: Post-intervention
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)?
Measured: Post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startFeb 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Skin Cancer PreventionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Responsible party
- Principal investigator, Sonia Duffy, University of Michigan
- Investigators
- Sonia A Duffy, PhD, RN, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804595
- Sponsor's protocol ID
- N015454-00
- Status last verified
- May 2014
- First submitted
- 26 Feb 2013
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18471586Armstrong 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.
PubMed 19917951Duffy 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.
PubMed 23530608
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Sun Protection Interventions for Operating Engineers
- ClinicalTrials.gov ID
- NCT01804595
- Acronym / sponsor ID
- N015454-00
- Conditions
- Skin Cancer Prevention
- Keywords
- Worksite intervention, Sun protection intervention, Operating Engineers
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Study start
- Feb 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sunscreen | Experimental | Other: Sunscreen, Behavioral: EducationTo 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. |
| Text Message Reminders | Experimental | Behavioral: Text-Message Reminders, Behavioral: EducationAs 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!"). |
| Sunscreen and Text Message Reminders | Experimental | Other: Sunscreen, Behavioral: Text-Message Reminders, Other: Sunscreen and Text Message Reminders, Behavioral: EducationJust 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. |
| Education | Active comparator | Behavioral: EducationA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sunscreen | Other | Sunscreen, Sunscreen and Text Message Reminders |
| Text-Message Reminders | Behavioural | Sunscreen and Text Message Reminders, Text Message Reminders |
| Sunscreen and Text Message Reminders | Other | Sunscreen and Text Message Reminders |
| Education | Behavioural | Education, Sunscreen, Sunscreen and Text Message Reminders, Text Message Reminders |
Primary outcome
Sunscreen use
Time frame: Baseline
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)?
Sun Burning
Time frame: Baseline
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)?
Sunscreen use
Time frame: Post-intervention
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)?
Sun Burning
Time frame: Post-intervention
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)?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
- Background: PubMed 18471586Walkosz 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.
- Background: PubMed 19917951Armstrong 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.
- Derived from this study: PubMed 23530608Duffy 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.
- FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S. 2011Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia A Duffy, PhD, RN principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sunscreen, Text-Message Reminders and Sunscreen and Text Message Reminders in people with Skin Cancer Prevention, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sunscreen use (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01804595, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.