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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.
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years - 75 Years |
| Gender | All |
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03927742 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
University of Minnesota |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
| Principal Investigator Affiliation | N/A |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
| Overall Status | Enrolling by invitation |
| Countries | United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Melanoma (Skin) |
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
