Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors

Melanoma (Skin) Clinical Trial

Official title:

Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03927742
• Other study ID #: 2019NTLS079
• Secondary ID: 133512-RSG-19-01
• Status: Completed
• Phase: N/A
• Start date: June 9, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: December 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: October 31, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Behavioral:
• Shade + app with messaging
Shade wearable device and application with UV messaging activated
• Shape + app without messaging
Shade wearable device and application without UV messaging activated

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota	American Cancer Society, Inc., Melanoma Research Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)