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Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shade + app with messaging
Shape + app without messaging
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Melanoma (Skin) focused on measuring sun protection, sunburn

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Shade and application with UV message activated

Shade and application without UV messaging

Arm Description

wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging activated

wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging not activated

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
April 15, 2019
Last Updated
January 12, 2023
Sponsor
University of Minnesota
Collaborators
American Cancer Society, Inc., Melanoma Research Alliance
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1. Study Identification

Unique Protocol Identification Number
NCT03927742
Brief Title
Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors
Official Title
Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 9, 2020 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
American Cancer Society, Inc., Melanoma Research Alliance

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
sun protection, sunburn

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
368 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shade and application with UV message activated
Arm Type
Experimental
Arm Description
wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging activated
Arm Title
Shade and application without UV messaging
Arm Type
Active Comparator
Arm Description
wearable device (wrist) and associated mobile application; UV sensor exposure display and messaging not activated
Intervention Type
Behavioral
Intervention Name(s)
Shade + app with messaging
Intervention Description
Shade wearable device and application with UV messaging activated
Intervention Type
Behavioral
Intervention Name(s)
Shape + app without messaging
Intervention Description
Shade wearable device and application without UV messaging activated
Primary Outcome Measure Information:
Title
Sun protection habits index
Description
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)
Time Frame
12 weeks (post intervention)
Secondary Outcome Measure Information:
Title
Self-report of sunburn in the past 12 weeks (Glanz et al., 2008)
Description
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.
Time Frame
12 weeks (post intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33228807
Citation
Vogel RI, Nagler RH, Ahmed RL, Brown K, Luo X, Martinson BC, Lazovich D. UVR-sensor wearable device intervention to improve sun behaviors and reduce sunburns in melanoma survivors: study protocol of a parallel-group randomized controlled trial. Trials. 2020 Nov 23;21(1):959. doi: 10.1186/s13063-020-04881-3.
Results Reference
derived

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Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors

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