Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors
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|ClinicalTrials.gov Identifier: NCT03927742|
Recruitment Status : Enrolling by invitation
First Posted : April 25, 2019
Last Update Posted : July 17, 2020
Over 5 million new cases of skin cancer are diagnosed in the United States each year, more than all other cancers combined. Most of these cases are caused by excess exposure to ultraviolet radiation from the sun and artificial sources such as indoor tanning. Melanoma, approximately 87,000 of the annual skin cancer cases and one of the more deadly skin cancers, is on the rise. Previous research on these individuals suggests that while some change how much time they spend in the sun and adopt ways to protect themselves when in the sun, many do not. In our previous study, we found that 20% of melanoma survivors reported a sunburn in the past year and 10% intentionally went outside for a tan, both strong indicators of inappropriate sun exposure. Melanoma survivors are at high risk of second melanomas, making it critical that they spend less time in the sun or take actions to protect themselves when they are in the sun.
No studies to date have investigated technology-based strategies in melanoma survivors to improve sun exposure and protection behaviors. This project will test whether a wearable device that tracks sun exposure and provides alerts regarding sun exposure and protection behaviors will increase sun protection behaviors in melanoma survivors. The use of wearable technology devices (e.g., Fitbit) has grown quickly over the last decade and studies using these devices to promote physical activity and weight loss have been promising. We will test the technology device versus a similar control device in 368 melanoma survivors and compare sun protection behaviors between the two groups.
This project has the potential to identify a strategy that could significantly lower the number of melanoma survivors who go on to have a second melanoma diagnosis. Importantly, this easy to use technology could also be utilized by survivors' family members, who are also at higher risk for melanoma, and the general population as a means to reduce risk of all forms of skin cancer.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Behavioral: Shade + app with messaging Behavioral: Shape + app without messaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||368 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors|
|Actual Study Start Date :||June 9, 2020|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||September 30, 2023|
Experimental: Shade and application with UV message activated
wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging activated
Behavioral: Shade + app with messaging
Shade wearable device and application with UV messaging activated
Active Comparator: Shade and application without UV messaging
wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging not activated
Behavioral: Shape + app without messaging
Shade wearable device and application without UV messaging activated
- Sun protection habits index [ Time Frame: 12 weeks (post intervention) ]Sun protection habits measured using Glanz et al., 2008 questionnaire and scored by taking the averaging of 6 protective behaviors (wearing a shirt with sleeves, wearing sunglasses, staying in the shade, using sunscreen, limiting time in the sun, and wearing a hat) on a 4-point ordinal scale ranging from 1 = rarely or never to 4 = always. (Glanz et al. 2010)
- Self-report of sunburn in the past 12 weeks (Glanz et al., 2008) [ Time Frame: 12 weeks (post intervention) ]Glanz et al. (2007) validated question: In the past 12 months, how many times did you have a red OR painful sunburn that lasted a day or more? Self-reported options include 0, 1, 2, 3, 4, 5 or more.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927742
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|