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Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927742
Recruitment Status : Enrolling by invitation
First Posted : April 25, 2019
Last Update Posted : July 17, 2020
Sponsor:
Collaborators:
American Cancer Society, Inc.
Melanoma Research Alliance
Information provided by (Responsible Party):
University of Minnesota

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
Melanoma (Skin) Behavioral: Shade + app with messaging Behavioral: Shape + app without messaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 9, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Sun protection habits index [ Time Frame: 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) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927742


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
American Cancer Society, Inc.
Melanoma Research Alliance
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03927742    
Other Study ID Numbers: 2019NTLS079
133512-RSG-19-014-01-CPPB ( Other Grant/Funding Number: American Cancer Society )
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
sun protection
sunburn
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas