Skip to main content
OpenTrials
Completed

NCT Number: NCT03927742

Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shade + app with messaging

Behavioral

Shade wearable device and application with UV messaging activated

Shape + app without messaging

Behavioral

Shade wearable device and application without UV messaging activated

Primary outcomes

  1. Sun Protection Habits Index

    Time frame: 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 outcomes

  1. Number of Participants With Sunburn in the Past 12 Weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • American Cancer Society, Inc.
  • Melanoma Research Alliance

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 25, 2019
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.