An interventional study of Goal attainment in Sunburn, Erythema and Sun Protection, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Northwestern University · Not applicable, Interventional, and Prevention
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.
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.
Cohort Study 1:
Inclusion Criteria:
Exclusion Criteria:
-
Cohort Study 2: Young adults with sun sensitive skin
Inclusion Criteria:
Exclusion Criteria:
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.
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.
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.
Behavioral: Goal attainment
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.
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.
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.
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.
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
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
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
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
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.
| Milestone | Focus Group | Usability Testing | Cohort Study 1- Arm 1 | Cohort Study 1 Arm 2 | Structured Interviews | Cohort Study 2 |
|---|---|---|---|---|---|---|
| Started | 32 | 10 | 31 | 29 | 20 | 42 |
| Completed | 32 | 10 | 31 | 29 | 20 | 40 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 2 |
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
| score on a scale | Usability Testing | Cohort Study 1 Arm1 | Cohort Study 1 Arm 2 | Cohort Study 2 |
|---|---|---|---|---|
| Acceptability of Wearing UV Sensor and Receiving Text Messages | 22 ± 3.5 | 39.1 ± 6.2 | 40.1 ± 5.3 | 40.6 ± 2.9 |
Change in daily UV exposure recorded by UV sensor (J/m\^2/day) between period prior to and after goal setting among melanoma survivors
| J/m^2/day | Cohort Study 1 Arm 1 | Cohort Study 1 Arm 2 |
|---|---|---|
| Sun Exposure in Participants With Structured vs Unstructured Goal Setting | 399.9 ± 10.6 | 196.8 ± 129.1 |
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.
| participants | Participant Reported Sunburns |
|---|---|
| Sunburns prior to intervention | 30 |
| Sunburns during intervention | 18 |
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.
| score on a scale | Focus Group | Usability Testing | Cohort Study 1-Arm 1 | Cohort Study 1- Arm 2 | Structured Interviews | Cohort Study 2 |
|---|---|---|---|---|---|---|
| Knowledge of Sun Protection | 13.2 ± 0.2 | 13.1 ± 0.5 | 17.9 ± 1.1 | 17.1 ± 1.2 | 12.2 ± 0.4 | 14.3 ± 0.6 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Focus Group | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Usability Testing | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Cohort Study 1-arm 1 | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Cohort Study 1-arm 2 | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Structured Interviews | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Cohort Study 2 | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Age, Categorical(Participants) | Focus Group | Usability Testing | Cohort Study 1 Arm 1 | Cohort Study 1 Arm 2 | Structured Interviews | Cohort Study 2 | Total |
|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 25 | 10 | 25 | 24 | 20 | 42 | 146 |
| >=65 years | 7 | 0 | 6 | 5 | 0 | 0 | 18 |
| Age, Continuous(years) | Focus Group | Usability Testing | Cohort Study 1 Arm 1 | Cohort Study 1 Arm 2 | Structured Interviews | Cohort Study 2 | Total |
|---|---|---|---|---|---|---|---|
| Mean | 57.4 ± 11.5 | 24.3 ± 3.2 | 59.3 ± 12.5 | 58.8 ± 10.2 | 21.2 ± 1.4 | 22.6 ± 4.5 | 48.2 ± 15.7 |
| Sex: Female, Male(Participants) | Focus Group | Usability Testing | Cohort Study 1 Arm 1 | Cohort Study 1 Arm 2 | Structured Interviews | Cohort Study 2 | Total |
|---|---|---|---|---|---|---|---|
| Female | 17 | 5 | 18 | 18 | 10 | 28 | 96 |
| Male | 15 | 5 | 13 | 11 | 10 | 14 | 68 |
| Race (NIH/OMB)(Participants) | Focus Group | Usability Testing | Cohort Study 1 Arm 1 | Cohort Study 1 Arm 2 | Structured Interviews | Cohort Study 2 | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 2 | 1 | 0 | 0 | 1 | 3 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| White | 30 | 9 | 31 | 29 | 18 | 36 | 153 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 2 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Region of Enrollment(Participants) | Focus Group | Usability Testing | Cohort Study 1 Arm 1 | Cohort Study 1 Arm 2 | Structured Interviews | Cohort Study 2 | Total |
|---|---|---|---|---|---|---|---|
| United States | 32 | 10 | 31 | 29 | 20 | 42 | 164 |
| Knowledge of Sun Protection(units on a scale) | Focus Group | Usability Testing | Cohort Study 1 Arm 1 | Cohort Study 1 Arm 2 | Structured Interviews | Cohort Study 2 | Total |
|---|---|---|---|---|---|---|---|
| Mean | 12 ± 1.7 | 13 ± 3.1 | 17 ± 2.3 | 18 ± 1.9 | 11 ± 1.4 | 11 ± 2.1 | 14 ± 2.1 |
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