Sunburn, Erythema, Sun Protection
Conditions
Keywords
Skin Cancer, Sunburn, erythema, UV Exposure, Sunburn, Wearable UV Device
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.
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.
Interventions
BEHAVIORALGoal 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.
Sponsors
National Cancer Institute (NCI)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
cohort study 1 and 2 were masked. Each participant was identified by a study number assigned in REDCap
Intervention model description
Cohort study 1 is parallel and randomized Cohort Study 2 is a single group study with comparison of the participants' reported sunburns prior to intervention and during the intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Wearing UV Sensor and Receiving Text Messages | cohort study 1 (arms 1 and 2) at end of 21 days, cohort study 2 (only one arm) at end of 28 days | Online system usability 6 item scale (Likert 7 items range from strongly disagree to strongly agree Minimum value 6, maximum value 42, higher score better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sun Exposure in Participants With Structured vs Unstructured Goal Setting | 21 days | Change in daily UV exposure recorded by UV sensor (J/m\^2/day) between period prior to and after goal setting among melanoma survivors |
Other
| Measure | Time frame | Description |
|---|---|---|
| Participant Reported Sunburns Prior to Intervention and During the Intervention | 56 days | Young adult participants with sun sensitive skin reported sunburns in the 28 days prior to the intervention and during the 28 days of the intervention. |
| Knowledge of Sun Protection | 2 months | Knowledge of sun protection using the scale after completing focus group after completing an arm of the study. The same scale was administered at baseline for each arm. 9 item scale (Minimum= 9, Maximum=18) Total range is 9-18. Higher value is better knowledge and a better outcome. |
Countries
United States
Participant flow
Recruitment details
Recruitment for the overall study: June 30, 2018 - June 30, 2020. Participants for the first cohort (cohort 1) were recruited using the Enterprise Data Warehouse of Northwestern University, which searches the electronic medical records of Northwestern Medicine for eligible participants. Participants for the second cohort (cohort 2) were recruited by posting electronic announcements on college websites and high school alumnae organizations in the Midwestern and Southeastern United States.
Pre-assignment details
After subject meets eligibility requirements and is enrolled they are assigned to an arm without a run-in or wash-out.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| 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. | 10 |
| Cohort Study 1 Arm 1 31 subjects
First cohort study: It is expected that each of 60 melanoma survivors in arms 1 + 2 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 in both arms 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 in arm 1 will be randomized to receive a survey item inviting selection of strategies to achieve sun-protected outdoor activities (structured goal attainment).
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. | 31 |
| Cohort Study 1 Arm 2 29 subjects
First cohort study: It is expected that each of 29 melanoma survivors in arm 2 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 in both arms 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 in arm 2 will be randomized to submit a free text description of their strategy (unstructured goal attainment).
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. | 29 |
| Structured Interviews 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. | 20 |
| Cohort Study 2 Second cohort study: 42 young adults will recall the number of days with a sunburn in the 28 days before the intervention. Then, the same young adults will wear the UV sensor daily for 28 days in summer 2020. The UV sensor will provide an alert when the UV exposure approaches the dose expected to produce a sunburn. Participants will report sunburns daily during the 28 days of the intervention. | 42 |
| Total | 164 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Usability Testing | Cohort Study 1 Arm 1 | Cohort Study 1 Arm 2 | Focus Group | Structured Interviews | Cohort Study 2 | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 6 Participants | 5 Participants | 7 Participants | 0 Participants | 0 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 25 Participants | 24 Participants | 25 Participants | 20 Participants | 42 Participants | 146 Participants |
| Age, Continuous | 24.3 years STANDARD_DEVIATION 3.2 | 59.3 years STANDARD_DEVIATION 12.5 | 58.8 years STANDARD_DEVIATION 10.2 | 57.4 years STANDARD_DEVIATION 11.5 | 21.2 years STANDARD_DEVIATION 1.4 | 22.6 years STANDARD_DEVIATION 4.5 | 48.2 years STANDARD_DEVIATION 15.7 |
| Knowledge of Sun Protection | 13 units on a scale STANDARD_DEVIATION 3.1 | 17 units on a scale STANDARD_DEVIATION 2.3 | 18 units on a scale STANDARD_DEVIATION 1.9 | 12 units on a scale STANDARD_DEVIATION 1.7 | 11 units on a scale STANDARD_DEVIATION 1.4 | 11 units on a scale STANDARD_DEVIATION 2.1 | 14 units on a scale STANDARD_DEVIATION 2.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 9 Participants | 31 Participants | 29 Participants | 30 Participants | 18 Participants | 36 Participants | 153 Participants |
| Region of Enrollment United States | 10 Participants | 31 Participants | 29 Participants | 32 Participants | 20 Participants | 42 Participants | 164 Participants |
| Sex: Female, Male Female | 5 Participants | 18 Participants | 18 Participants | 17 Participants | 10 Participants | 28 Participants | 96 Participants |
| Sex: Female, Male Male | 5 Participants | 13 Participants | 11 Participants | 15 Participants | 10 Participants | 14 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 10 | 0 / 31 | 0 / 29 | 0 / 20 | 0 / 42 |
| other Total, other adverse events | 0 / 32 | 0 / 10 | 0 / 31 | 0 / 29 | 0 / 20 | 0 / 42 |
| serious Total, serious adverse events | 0 / 32 | 0 / 10 | 0 / 31 | 0 / 29 | 0 / 20 | 0 / 42 |
Outcome results
Primary
Acceptability of Wearing UV Sensor and Receiving Text Messages
Online system usability 6 item scale (Likert 7 items range from strongly disagree to strongly agree Minimum value 6, maximum value 42, higher score better outcome
Time frame: cohort study 1 (arms 1 and 2) at end of 21 days, cohort study 2 (only one arm) at end of 28 days
Population: Focus groups and structured interviews did not have data collected for acceptability of wearing the UV sensor and receiving text messages.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usability Testing | Acceptability of Wearing UV Sensor and Receiving Text Messages | 22 score on a scale | Standard Deviation 3.5 |
| Cohort Study 1 Arm1 | Acceptability of Wearing UV Sensor and Receiving Text Messages | 39.1 score on a scale | Standard Deviation 6.2 |
| Cohort Study 1 Arm 2 | Acceptability of Wearing UV Sensor and Receiving Text Messages | 40.1 score on a scale | Standard Deviation 5.3 |
| Cohort Study 2 | Acceptability of Wearing UV Sensor and Receiving Text Messages | 40.6 score on a scale | Standard Deviation 2.9 |
p-value: <0.01Chi-squared
Secondary
Sun Exposure in Participants With Structured vs Unstructured Goal Setting
Change in daily UV exposure recorded by UV sensor (J/m\^2/day) between period prior to and after goal setting among melanoma survivors
Time frame: 21 days
Population: UV exposure as recorded by the UV sensor in J/m\^2 per day from period 1 (prior to goal setting) to period 2 (after goal setting) only applies to cohort study 1. The other study arms focus group, usability test, unstructured interview and Cohort study 2 did not have data collected.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Usability Testing | Sun Exposure in Participants With Structured vs Unstructured Goal Setting | 399.9 J/m^2/day | Standard Error 10.6 |
| Cohort Study 1 Arm1 | Sun Exposure in Participants With Structured vs Unstructured Goal Setting | 196.8 J/m^2/day | Standard Error 129.1 |
p-value: <0.001Chi-squared, Corrected
Other Pre-specified
Knowledge of Sun Protection
Knowledge of sun protection using the scale after completing focus group after completing an arm of the study. The same scale was administered at baseline for each arm. 9 item scale (Minimum= 9, Maximum=18) Total range is 9-18. Higher value is better knowledge and a better outcome.
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usability Testing | Knowledge of Sun Protection | 13.2 score on a scale | Standard Deviation 0.2 |
| Cohort Study 1 Arm1 | Knowledge of Sun Protection | 13.1 score on a scale | Standard Deviation 0.5 |
| Cohort Study 1 Arm 2 | Knowledge of Sun Protection | 17.9 score on a scale | Standard Deviation 1.1 |
| Cohort Study 2 | Knowledge of Sun Protection | 17.1 score on a scale | Standard Deviation 1.2 |
| Structured Interviews | Knowledge of Sun Protection | 12.2 score on a scale | Standard Deviation 0.4 |
| Cohort Study 2 | Knowledge of Sun Protection | 14.3 score on a scale | Standard Deviation 0.6 |
Comparison: Knowledge of sun protection score at baseline compared with score after completion of the arm. The hypothesis is that the focus group, usability test and structured interviews arms will not have significant change in knowledge. It is expected that cohort studies 1 and 2 will have significant change in knowledge of sun protection.p-value: <0.1Chi-squared
Other Pre-specified
Participant Reported Sunburns Prior to Intervention and During the Intervention
Young adult participants with sun sensitive skin reported sunburns in the 28 days prior to the intervention and during the 28 days of the intervention.
Time frame: 56 days
Population: This is a single arm study for cohort 2. Data on sunburns was not collected for the other arms.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usability Testing | Participant Reported Sunburns Prior to Intervention and During the Intervention | Sunburns prior to intervention | 30 participants |
| Usability Testing | Participant Reported Sunburns Prior to Intervention and During the Intervention | Sunburns during intervention | 18 participants |
p-value: <0.01Chi-squared