- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Tammy Stump, PhD
- Telefonní číslo: 801-646-4201
- E-mail: Tammy.Stump@hci.utah.edu
Studijní místa
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Utah
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Salt Lake City, Utah, Spojené státy, 84112
- Nábor
- Tammy Stump
-
Kontakt:
- Tammy Stump, PhD
- Telefonní číslo: 801-646-4201
- E-mail: Tammy.Stump@hci.utah.edu
-
Vrchní vyšetřovatel:
- Tammy Stump, PhD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Jiný: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Proportion of Participants with a Clinically Significant Impact
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Tammy Stump, PhD, Huntsman Cancer Institute
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
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