Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors

Not Applicable

Completed

• Conditions: Melanoma (Skin)
• Interventions: Behavioral: Shade + app with messaging; Behavioral: Shape + app without messaging

• Registration Number: NCT03927742
• Lead Sponsor: University of Minnesota

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-25
• Study Start: 2020-06-09
• Primary Completion: 2021-11-01
• Study Completion: 2022-10-31
• Results First Submitted: 2023-02-24
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-06
• Last Update Submitted: 2023-12-06
• Results First Posted: 2024-05-13
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 368

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

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Exclusion Criteria

• Patients who have opted out of their records being used for research purposes
• Inability to provide informed written consent
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shade and application with UV message activated	Shade + app with messaging	wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging activated
Shade and application without UV messaging	Shape + app without messaging	wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging not activated

Primary Outcome Measures

Name	Time	Method
Sun Protection Habits Index	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).; Higher score indicates better sun protection behaviors

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Sunburn in the Past 12 Weeks	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States