Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors

Sponsor
University of Minnesota (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03927742
Collaborator
American Cancer Society, Inc. (Other), Melanoma Research Alliance (Other)
368
1
2
29.7
12.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Shade + app with messaging
  • Behavioral: Shape + app without messaging
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
368 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors
Actual Study Start Date :
Jun 9, 2020
Actual Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Sun protection habits index [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)

Secondary Outcome Measures

  1. Self-report of sunburn in the past 12 weeks (Glanz et al., 2008) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Minnesota Minneapolis Minnesota United States 55455

Sponsors and Collaborators

  • University of Minnesota
  • American Cancer Society, Inc.
  • Melanoma Research Alliance

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT03927742
Other Study ID Numbers:
  • 2019NTLS079
  • 133512-RSG-19-014-01-CPPB
First Posted:
Apr 25, 2019
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Minnesota
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2022