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.

Study Overview

• Status: Completed
• Conditions: Melanoma (Skin)
• Intervention / Treatment: Behavioral: Shade + app with messaging; Behavioral: Shape + app without messaging

• Study Type: Interventional
• Enrollment (Actual): 368
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shade and application with UV message activated; wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging activated	Behavioral: Shade + app with messaging; Shade wearable device and application with UV messaging activated
Active Comparator: Shade and application without UV messaging; wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging not activated	Behavioral: Shape + app without messaging; Shade wearable device and application without UV messaging activated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sun Protection Habits Index	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	12 weeks (post intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Sunburn in the Past 12 Weeks	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.	12 weeks (post intervention)

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: American Cancer Society, Inc.; Melanoma Research Alliance

Publications and helpful links

General Publications

• Vogel RI, Nagler RH, Ahmed RL, Brown K, Luo X, Martinson BC, Lazovich D. UVR-sensor wearable device intervention to improve sun behaviors and reduce sunburns in melanoma survivors: study protocol of a parallel-group randomized controlled trial. Trials. 2020 Nov 23;21(1):959. doi: 10.1186/s13063-020-04881-3.

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2020
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 25, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: sun protection; sunburn
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Melanoma
• Other Study ID Numbers: 2019NTLS079; 133512-RSG-19-014-01-CPPB (Other Grant/Funding Number: American Cancer Society)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No