UV Exposure Assessed With Wearable Sensor and Sun Protection

Northwestern University

Status: Completed

Conditions: Sun Protection; Sunburn, Erythema

Treatments: Behavioral: Goal attainment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03344796

R44CA224658 (U.S. NIH Grant/Contract)

STU00205910

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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164 participants in 6 patient groups

Focus Group

No Intervention group

Description:

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. Baseline knowledge of sun protection performed prior to and at end of focus group.

Usability testing

No Intervention group

Description:

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. Baseline knowledge of sun protection performed prior to and at end of usability test.

Cohort Study 1-Arm 1

Active Comparator group

Description:

31 subjects First cohort study: It is expected that 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 in Arm 1 to receive a survey item inviting selection of strategies to achieve sun-protected outdoor activities (structured goal attainment). Baseline knowledge of sun protection performed prior to and at end of intervention.

Treatment:

Behavioral: Goal attainment

Structured Interviews

No Intervention group

Description:

20 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. Baseline knowledge of sun protection will be performed prior to and after structured interviews.

Cohort Study 2

No Intervention group

Description:

Second cohort study: 42 young adult participants will recall the number of sunburns experienced in the 28 days prior to enrolling in the study. Then, the same young adult participants will wear the UV sensor daily for 28 summer days. Participants will receive a warning on their mobile phone if the UV dose approaches the dose anticipated to cause sunburn in unprotected skin. Participants will record the number of days in which they get a sunburn. Baseline knowledge of sun protection performed prior to and at end of study.

Cohort Study 1- Arm 2

Active Comparator group

Description:

29 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 in Arm 2 to submit a free text description of their strategy (unstructured goal attainment). Baseline knowledge of sun protection performed prior to and at end of intervention.

Treatment:

Behavioral: Goal attainment