Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors

Study Overview
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Brief Summary
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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.

Official Title
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Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Behavioral: Shade + app with messaging
* Behavioral: Shape + app without messaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 years old Diagnosed with cutaneous invasive melanoma within HealthPartners system Able to read/write in English Own a smartphone Able to provide voluntary informed consent Exclusion Criteria: Patients who have opted out of their records being used for research purposes Inability to provide informed written consent Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shade and application with UV message activated<br>wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging activated | Behavioral: Shade + app with messaging<br>* Shade wearable device and application with UV messaging activated<br>|
| Active Comparator: Shade and application without UV messaging<br>wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging not activated | Behavioral: Shape + app without messaging<br>* Shade wearable device and application without UV messaging activated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sun protection habits index | 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) | 12 weeks (post intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-report of sunburn in the past 12 weeks (Glanz et al., 2008) | 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. | 12 weeks (post intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sun protection, sunburn