- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07830394
Mobile Sun Health Intervention EnabLing Daily Protection (mSHIELD)
mSHIELD (Mobile Sun Health Intervention EnabLing Daily Protection)
The overall purpose of this proposal is to refine a mobile-health (mHealth) system to reduce excessive unprotected sun exposure among young adults.
Participants will complete a 4-week intervention with all intervention components delivered through the mHealth application. Intervention components include Text Message Reminders, Sun Protection Education Modules, Action Planning Module, and UV Radiation (UVR) Weather Information.
Study Overview
Status
Conditions
Detailed Description
mHealth tools provide an ideal opportunity for reducing young adults' UVR exposure. mSHIELD intervention components were selected to target key constructs (e.g., self-efficacy, barrier reduction) within Social Cognitive Theory (SCT) which are associated with sun protection behaviors. The initial concept for the mSHIELD intervention includes the following four components: real-time UVR alerts and feedback; UVR weather forecasts; text messages; and action planning. Although these components provide a good fit with SCT constructs and utilize evidence-based behavior change strategies, they have rarely been used in the context of mHealth for sun protection, and this will be the first mHealth intervention for sun protection to apply all four of these components simultaneously. Therefore, prior to testing mSHIELD in a large study, it will be important to refine components based on user preferences and pilot tests.
To test the pilot intervention, participants will complete a 4-week intervention with all intervention components delivered through the study application. Intervention components will include: text messages, sun protection education modules, an action planning module, and UVR/weather information. The modules/components are used for the entire 4-week intervention period. Immediately following the 4-week intervention, participants will be asked to complete a post-intervention survey and study interview. Participants will also be asked to complete a survey one month post-intervention. Participants will receive up to 5 reminders to complete each study activity through each of their approved communication methods (e.g., email).
Data collected at the one-month post-intervention surveys will be analyzed and compared to baseline values. For this study, the criteria for a clinically significant impact will be that a participant reports no sunburns and now frequently uses sunscreen and at least one other sun protection method during outdoor time; a priori, a benchmark of at least 50% of participants reaching this criteria is set to indicate whether the intervention can proceed to larger-scale testing or if further refinements are needed.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tammy Stump, PhD
- Phone Number: 801-646-4201
- Email: Tammy.Stump@hci.utah.edu
Study Locations
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Utah
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Salt Lake City, Utah, United States, 84112
- Recruiting
- Tammy Stump
-
Contact:
- Tammy Stump, PhD
- Phone Number: 801-646-4201
- Email: Tammy.Stump@hci.utah.edu
-
Principal Investigator:
- Tammy Stump, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Individual is at least 18 years old; AND
- Individual reports having at least one sunburn in the last year; AND/OR
- Individual reports using sunscreen plus one or more other sun protection behavior (protective clothing, shade, etc.) infrequently (i.e. never/seldom/sometimes)
Exclusion Criteria:
- Individual does not speak/read English; AND/OR
- Individual reports a personal history of skin cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: mSHIELD (mobile Sun Health Intervention EnabLing Daily Protection)
Participants will complete a 4-week intervention with all intervention components delivered through the study application. Intervention components will include: text messages, sun protection education modules, an action planning module, and ultraviolet radiation (UVR)/weather information. The modules/components are used for the entire 4-week intervention period. |
Participants will receive text message reminders twice a week. These messages will remind participants to use sunscreen or other forms of sun protection and will include brief facts about sun safety and environmental risks. The education section consists of 5 modules on sun protection basics, ultraviolet (UV) exposure, skin health, sunscreen use, and tanning. Each module takes about 5 to 10 minutes to read. The app will guide participants through creating a specific plan for using sun protection during a routine outdoor activity. Completing an action plan takes about 5 minutes. Participants will be asked to complete two action plans during the study and prompted to review these plans weekly. The UVR Weather feature displays information similar to what is available in many weather apps, with a focus on the sunburn risk hours. The display also shows different levels of UV risk throughout the day and indicates the current UV risk based on real-time UV Index. Participants will receive a daily notification summarizing the UV information for that day. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of Participants with a Clinically Significant Impact
Time Frame: up to 2 months from baseline
|
To determine whether a prototype mHealth system improves use of sun protection strategies among young adults. Data at the one-month post-intervention surveys will be analyzed and compared to baseline values. For this study, the criteria for a clinically significant impact will be that a participant reports no sunburns and now frequently uses sunscreen and at least one other sun protection method during outdoor time. This outcome measure will report the proportion of participants with a clinically significant impact. |
up to 2 months from baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tammy Stump, PhD, Huntsman Cancer Institute
Publications and helpful links
General Publications
- Rogers HW, Weinstock MA, Feldman SR, Coldiron BM. Incidence Estimate of Nonmelanoma Skin Cancer (Keratinocyte Carcinomas) in the U.S. Population, 2012. JAMA Dermatol. 2015 Oct;151(10):1081-6. doi: 10.1001/jamadermatol.2015.1187.
- Youl PH, Soyer HP, Baade PD, Marshall AL, Finch L, Janda M. Can skin cancer prevention and early detection be improved via mobile phone text messaging? A randomised, attention control trial. Prev Med. 2015 Feb;71:50-6. doi: 10.1016/j.ypmed.2014.12.009. Epub 2014 Dec 16.
- Bandura A. Social learning of moral judgments. J Pers Soc Psychol. 1969 Mar;11(3):275-9. doi: 10.1037/h0026998. No abstract available.
- Parkin DM, Mesher D, Sasieni P. 13. Cancers attributable to solar (ultraviolet) radiation exposure in the UK in 2010. Br J Cancer. 2011 Dec 6;105 Suppl 2(Suppl 2):S66-9. doi: 10.1038/bjc.2011.486. No abstract available.
- Christenson LJ, Borrowman TA, Vachon CM, Tollefson MM, Otley CC, Weaver AL, Roenigk RK. Incidence of basal cell and squamous cell carcinomas in a population younger than 40 years. JAMA. 2005 Aug 10;294(6):681-90. doi: 10.1001/jama.294.6.681.
- Melanoma Research Alliance. Melanoma Statistics. https://www.curemelanoma.org/about-melanoma/melanoma-101/melanoma-statistics-2#:~:text=On%20age%20related%20cancers%2C%20melanoma,melanoma%20increases%20as%20people%20age.
- Holman DM, Ding H, Guy GP Jr, Watson M, Hartman AM, Perna FM. Prevalence of Sun Protection Use and Sunburn and Association of Demographic and Behaviorial Characteristics With Sunburn Among US Adults. JAMA Dermatol. 2018 May 1;154(5):561-568. doi: 10.1001/jamadermatol.2018.0028.
- Anderson M, Jiang J. Teens, social media & technology 2018. Pew Research Center. 2018;31(2018):1673-1689.
- Rideout V, Fox S. Digital health practices, social media use, and mental well-being among teens and young adults in the US. 2018;
- Lupton D. Young People's Use of Digital Health Technologies in the Global North: Narrative Review. J Med Internet Res. 2021 Jan 11;23(1):e18286. doi: 10.2196/18286.
- Robinson JK, Patel S, Heo SY, Gray E, Lim J, Kwon K, Christiansen Z, Model J, Trueb J, Banks A, Kwasny M, Rogers JA. Real-Time UV Measurement With a Sun Protection System for Warning Young Adults About Sunburn: Prospective Cohort Study. JMIR Mhealth Uhealth. 2021 May 6;9(5):e25895. doi: 10.2196/25895.
- Hacker E, Horsham C, Vagenas D, Jones L, Lowe J, Janda M. A Mobile Technology Intervention With Ultraviolet Radiation Dosimeters and Smartphone Apps for Skin Cancer Prevention in Young Adults: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Nov 28;6(11):e199. doi: 10.2196/mhealth.9854.
- Horsham C, Baade P, Kou K, O'Hara M, Sinclair C, Loescher LJ, Soyer HP, Janda M. Optimizing Texting Interventions for Melanoma Prevention and Early Detection: A Latin Square Crossover RCT. Am J Prev Med. 2021 Sep;61(3):348-356. doi: 10.1016/j.amepre.2021.03.024. Epub 2021 Jul 21.
- Bandura A, Grusec JE, Menlove FL. Some social determinants of self-monitoring reinforcement systems. J Pers Soc Psychol. 1967 Apr;5(4):449-55. doi: 10.1037/h0024392. No abstract available.
- Jackson KM, Aiken LS. A psychosocial model of sun protection and sunbathing in young women: the impact of health beliefs, attitudes, norms, and self-efficacy for sun protection. Health Psychol. 2000 Sep;19(5):469-78. doi: 10.1037//0278-6133.19.5.469.
- Heckman CJ, Manne SL, Kloss JD, Bass SB, Collins B, Lessin SR. Beliefs and intentions for skin protection and UV exposure in young adults. Am J Health Behav. 2011 Nov;35(6):699-711.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Skin Diseases
- Skin and Connective Tissue Diseases
- Skin Neoplasms
- Environment and Public Health
- Physical Phenomena
- Environment
- Ecological and Environmental Phenomena
- Biological Phenomena
- Weather
- Atmosphere
- Meteorological Concepts
- Electromagnetic Phenomena
- Magnetic Phenomena
- Electromagnetic Radiation
- Radiation
- Radiation, Ionizing
- Light
- Optical Phenomena
- Radiation, Nonionizing
- Sunlight
- Ultraviolet Rays
Other Study ID Numbers
- 191461
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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