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NCT03927742

Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors

Completed NA Results posted Last updated 13 May 2024
What this trial tests

NA trial testing Shade + app with messaging in Melanoma (Skin) in 368 participants. Completed in 31 October 2022.

Timeline
9 June 2020
Primary endpoint
1 November 2021
31 October 2022

Quick facts

Lead sponsorUniversity of Minnesota
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment368
Start date9 June 2020
Primary completion1 November 2021
Estimated completion31 October 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Minnesota

Who can join

Adults 18 to 75, any sex, with Melanoma (Skin). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sun Protection Habits Index Primary · 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

GroupValue95% CI
Shade and Application With UV Message Activated2.9± 0.5
Shade and Application Without UV Messaging3± 0.5
Number of Participants With Sunburn in the Past 12 Weeks Secondary · 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.

GroupValue95% CI
Shade and Application With UV Message Activated55
Shade and Application Without UV Messaging54

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Application of wearables for remote monitoring of oncology patients: A scoping review.
    Cloß K, Verket M, Müller-Wieland D, Marx N, et al · · 2024 · cited 16× · PMID 38481796 · DOI 10.1177/20552076241233998
  2. Integrating Artificial Intelligence-Driven Wearable Technology in Oncology Decision-Making: A Narrative Review.
    Birla M, Rajan, Roy PG, Gupta I, et al · · 2025 · cited 14× · PMID 39072365 · DOI 10.1159/000540494
  3. A UVR-sensor wearable device intervention to reduce sun exposure in melanoma survivors: Results from a randomized controlled trial.
    Vogel RI, Luo X, Brown K, Jewett P, et al · · 2023 · cited 6× · PMID 36763627 · DOI 10.1371/journal.pone.0281480
  4. UVR-sensor wearable device intervention to improve sun behaviors and reduce sunburns in melanoma survivors: study protocol of a parallel-group randomized controlled trial.
    Vogel RI, Nagler RH, Ahmed RL, Brown K, et al · · 2020 · cited 3× · PMID 33228807 · DOI 10.1186/s13063-020-04881-3

Verify or expand the search:

Other recruiting trials for Melanoma (Skin)

Currently open trials in the same condition.

Other University of Minnesota trials

Trials by the same sponsor.

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Data sources for this page

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