CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 368 enrolled
Drug / intervention
Shade + app with messaging +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03927742
NCT03927742N/ACompleted

Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors

University of Minnesota·interventional·Posted Apr 25, 2019·Updated May 13, 2024

In Brief

A clinical study evaluating Shade + app with messaging and Shape + app without messaging for Melanoma (Skin). Completed, enrolled 368 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma (Skin)
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 25, 2019
Enrollment StartJun 9, 2020
Primary CompletionNov 1, 2021
Study CompletionOct 31, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.2 years ago

Interventions

Shade + app with messagingbehavioral

Shade wearable device and application with UV messaging activated

Shape + app without messagingbehavioral

Shade wearable device and application without UV messaging activated