Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors

University of Minnesota (UMN)

Status: Completed

Conditions: Melanoma (Skin)

Treatments: Behavioral: Shape + app without messaging; Behavioral: Shade + app with messaging

Study type: Interventional

Funder types: Other

Identifiers

NCT03927742

2019NTLS079

133512-RSG-19-014-01-CPPB (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 368 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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368 participants in 2 patient groups

Shade and application with UV message activated

Experimental group

Description:

wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging activated

Treatment:

Behavioral: Shade + app with messaging

Shade and application without UV messaging

Active Comparator group

Description:

wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging not activated

Treatment:

Behavioral: Shape + app without messaging