UV Exposure Assessed With Wearable Sensor and Sun Protection

• ClinicalTrials.gov Identifier: NCT03344796
• Recruitment Status: Completed
• First Posted: November 17, 2017
• Last Update Posted: January 25, 2021
• Sponsor: Northwestern University
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): June Robinson, Northwestern University

Study Description

Brief Summary:

The goal is to prevent ultraviolet light (UV) overexposure by providing consumers with relevant, easy-to-access, specifically actionable information. This research proposal will develop a UV protection system consisting of an automated real-time counseling framework and a personal dosimeter that overcomes barriers to consumer adoption. These new, wearable sensors take the form of small (< 1 cm), thin (<0.1 mm), lightweight (<0.1 g), battery-free "stickers" that are fundamentally differentiated from other wearable electronics in their modes of use, cost structures and accuracy.

Condition or disease	Intervention/treatment
Sunburn, Erythema; Sun Protection	Behavioral: Goal attainment

Detailed Description:

The proposed work is to refine and validate a UV protection system based on a dosimeter "sticker." The key innovations of the system are automated personalized intervention messaging triggered by the exposure levels measured by a novel charge accumulation device applied to ultraminiaturized circuit forms. The research will validate the system's accuracy and acceptability to users, refine the device, and prove its robustness and efficacy in real world use cases. Focus groups and structured interviews will develop sun protection strategies to be communicated by text messages to participants. Successful completion of the research will yield a system to prevent excessive UV exposure and sunburn, thus reducing the incidence of skin cancer by equipping large numbers of general-population consumers and at-risk people to practice digitally-informed healthy sun behavior.

Study Design

• Study Type: Observational
• Actual Enrollment: 188 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Real-time, Cost-effective, Accurate UV Measurement and Sun Protection System to Prevent and Reduce the Incidence of Sunburn in High-risk Consumers
• Actual Study Start Date: June 30, 2018
• Actual Primary Completion Date: September 30, 2020
• Actual Study Completion Date: September 30, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
Focus Group; 32 subjects Focus group: It is expected that each participant will provide comments during the 2 hours of the focus group. It will take about one month to enroll the subjects. The audio files should be transcribed and the analysis completed in 60 days. The analysis will determine enablers and barriers to sun protected outdoor activities and determine strategies for achieving sun protected outdoor activities.
Usability testing; 10 subjects Usability test with structured interview: Each participant will use the sensor for 14 days and transmit data with the app installed on their mobile phone. It will take about one month to enroll the subjects. The analysis of the structured interview is completed in one week.
Cohort Study 1; 60 subjects First cohort study: It is expected that each of 60 melanoma survivors will wear the sensor and transmit data for 21 days in the warm weather months of June-Aug 2019. It will take about 2 months to enroll the subjects. Subjects will receive daily text messages in a sequence starting with behavioral facilitation, outcome expectancies, self-efficacy, and self-regulation. On day 10, participants will receive a text message prompting review and reflection on the prior 10 days of UV exposure. Participants will be randomized to receive a survey item inviting selection of strategies to achieve sun-protected outdoor activities (structured goal attainment) or submit a free text description of their strategy (unstructured goal attainment).	Behavioral: Goal attainment; After reviewing daily UV exposure in the prior 10 days, participants will be randomized to structured (select strategies from a list of 7 items) or unstructured (submit a free text description of a strategy) goal attainment.
Structured Interviews; 50 young adults, ages 18-39 will participate in structured interviews to determine their barriers and enablers of sun exposure and sun protection. Eligible subjects will have at least one hour a day outdoors with 30 minutes of the hour being consecutive. It will take about 3 months to enroll the subjects. The audio files will be transcribed and analysis completed in 60 days.
Cohort Study 2; Second cohort study: 40 young adults will wear the sensor and transmit data for 28 days in summer 2020.

Outcome Measures

Primary Outcome Measures :

1. Acceptability of wearing the UV sensor and receiving text based behavioral messages [ Time Frame: 21 days ]
   Assess acceptability of use with exit interviews and online system usability scale

Secondary Outcome Measures :

1. Change in sun protection in participants with structured goal setting vs unstructured goal setting [ Time Frame: baseline-10 days, 11-21 days ]
   Participants randomized 1:1 to structured or unstructured goal setting will complete a daily online survey of sun protection used. The goal setting activity occurs on the evening of day 10. This online sun protection survey was published by this team. [Stump TK, Aspinwall LG, Gray EL, Xu S, Maganti N, Leachman SA, Robinson JK. Daily minutes of unprotected sun exposure (MUSE) inventory: measure description and comparisons to UV sensor and sun protection survey data. Prev Med Reports 2018:11;305-311.]

Other Outcome Measures:

1. Change in daily UV Dose [ Time Frame: Melanoma survivors:baseline-10 days, 11-21 days. Young adults: 28 days ]

   Sensor reports of daily UV exposure for participants (melanoma survivors) randomized 1:1 to structured or unstructured goal setting were compared for 2 periods (days baseline-10 days prior to goal setting and days 11-21 days after goal setting. Participants in the structured goal setting arm maintained the reduction in daily UV exposure.

   The study among young adults had three consecutive periods. The intervention intensity increased as follows: a) real-time UVB dose, b) UVB dose and daily behavioral facilitation text messages, and c) UVB dose, goal setting, and daily text messages to support self-efficacy and self-regulation. The daily UVB dose decreased during the three periods; however, the change was not statistically significant. Among young adults, aged 18-39 years, sunburns were experienced during the study by fewer subjects (n=18) than in the 28 days preceding the study (n=30).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Cohort Study 1: Adults ages 18-70 years with a history of Stage 0 to IIB melanoma treated within the last five years Cohort Study 2:Adults ages 18-39 years with sun sensitive skin (Skin types that can sunburn)

Criteria

Cohort Study 1:

Inclusion Criteria:

1. history of Stage 0 to IIB melanoma treated within the last five years, age 18-70 years old
2. have a smartphone
3. familiarity with use of mobile apps
4. have skin type 1-3
5. willing to wear the sensor and able to transmit data which requires Wi-Fi in the home
6. Come to the Chicago campus of the medical school

Exclusion Criteria:

-

Cohort Study 2: Young adults with sun sensitive skin

Inclusion Criteria:

1. history of sun sensitive skin, skin type 1-3
2. have a smartphone and willing to use the UV guard application on the smartphone
3. reliable wireless internet connection to complete daily surveys
4. willing to wear the sensor for 28 days and transmit data and complete daily surveys
5. willing to receive SMS text messages on their personal phone and potentially sync sensor to personal phone using Bluetooth
6. If weather permits, person will spend at least one hour outdoors each day, with at least 30 minutes of that hour being consecutive between the hours of 8 AM and 5 PM

Exclusion Criteria:

1. unable to speak English
2. lacking a secure Internet connection or very little experience with smartphones and mobile applications .
3. unable to walk inside and outside independently
4. unable to be outdoors for at least one hour each day (weather permitting)
5. unable to be outdoors for 30 consecutive minutes a day between 8 AM and 5 PM.

Contacts and Locations

Locations

United States, Illinois

Northwestern University Feinberg School of Medicine Department of Dermatology

Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

National Cancer Institute (NCI)

Investigators

• Principal Investigator: June K. Robinson, MD; Northwestern University

  Study Documents (Full-Text)

Documents provided by June Robinson, Northwestern University:

Informed Consent Form  [PDF] March 11, 2019

Study Protocol and Statistical Analysis Plan  [PDF] March 18, 2019

More Information

Publications of Results:

Robinson JK, Durst DA, Gray E, Kwasny M, Heo SY, Banks A, Rogers JA. Sun exposure reduction by melanoma survivors with wearable sensor providing real-time UV exposure and daily text messages with structured goal setting. Arch Dermatol Res. 2021 Oct;313(8):685-694. doi: 10.1007/s00403-020-02163-1. Epub 2020 Nov 13.

Stump TK, Aspinwall LG, Gray EL, Xu S, Maganti N, Leachman SA, Alshurafa N, Robinson JK. Daily Minutes of Unprotected Sun Exposure (MUSE) Inventory: Measure description and comparisons to UVR sensor and sun protection survey data. Prev Med Rep. 2018 Jul 24;11:305-311. doi: 10.1016/j.pmedr.2018.07.010. eCollection 2018 Sep.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Robinson JK, Patel S, Heo SY, Gray E, Lim J, Kwon K, Christiansen Z, Model J, Trueb J, Banks A, Kwasny M, Rogers JA. Real-Time UV Measurement With a Sun Protection System for Warning Young Adults About Sunburn: Prospective Cohort Study. JMIR Mhealth Uhealth. 2021 May 6;9(5):e25895. doi: 10.2196/25895.

• Responsible Party: June Robinson, Primary Investigator, Northwestern University
• ClinicalTrials.gov Identifier: NCT03344796
• Other Study ID Numbers: STU00205910; R44CA224658 ( U.S. NIH Grant/Contract )
• First Posted: November 17, 2017
• Last Update Posted: January 25, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• 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 June Robinson, Northwestern University:

Skin Cancer; Sunburn, erythema; UV Exposure, Sunburn; Wearable UV Device

Additional relevant MeSH terms:

Erythema; Sunburn; Skin Diseases; Skin Manifestations; Photosensitivity Disorders; Burns; Wounds and Injuries