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N/A N=368 Randomized Single-blind Prevention

Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors

Melanoma (Skin)

Enrolled (actual)
368
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Sun Protection Habits Index — 2.9; 3 scores on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Shade + app with messaging (Behavioral); Shape + app without messaging (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Minnesota
Primary completion
Nov 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Sun Protection Habits Index
2.9; 3
SECONDARY
Number of Participants With Sunburn in the Past 12 Weeks
55; 54

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03927742). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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