Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Wounds and Injuries

Skin Neoplasms

Erythema

Sunburn

Skin Diseases

Skin Manifestations

Photosensitivity Disorders

Burns

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.

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.

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.

Goal attainment

June K. Robinson, MD

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 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

cohort study 1 and 2 were masked. Each participant was identified by a study number assigned in REDCap

UV Exposure Assessed With Wearable Sensor and Sun Protection

A Real-time, Cost-effective, Accurate UV Measurement and Sun Protection System to Prevent and Reduce the Incidence of Sunburn in High-risk Consumers

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 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.

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

Change in daily UV exposure recorded by UV sensor (J/m\^2/day) between period prior to and after goal setting among melanoma survivors

National Cancer Institute (NCI)

Northwestern University

Primary Investigator

Focus groups and structured interviews which involve talking with subjects have no risk of adverse medical events.

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.

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.

Usability Testing

31 subjects

First cohort study: It is expected that each 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).

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.

Cohort Study 1-arm 1

29 subjects 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).

Cohort Study 1-arm 2

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.

Structured Interviews

Second cohort study: 42 young adults will wear the sensor and transmit data for 28 days in summer 2020.

Cohort Study 2

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.

Cohort Study 1 Arm 1

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.

Cohort Study 1 Arm 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.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

9 item scale (Minimum= 9, Maximum=18) Total range is9-18. Higher value is better knowledge and a better outcome.

Knowledge of Sun Protection

Dr. June Robinson

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 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).

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.

Cohort Study 1 Arm1

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 tosubmit 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.

Focus groups and structured interviews did not have data collected for acceptability of wearing the UV sensor and receiving text messages.

Acceptability of Wearing UV Sensor and Receiving Text Messages

31 subjects

First cohort study: It is expected that melanoma survivors in arm 1 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).

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.

Subjects in arm 2 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. 29 participants in arm 2 will be randomized to submit a free text description of their strategy (unstructured goal attainment).

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.

Sun Exposure in Participants With Structured vs Unstructured Goal Setting

Sunburns prior to intervention

Sunburns during intervention

Young adults with sun sensitive skin reported the number of days with a sunburn for the 28 days prior to the intervention. Then participants reported daily sunburn during the study.

Participant Reported Sunburns

This is a single arm study for cohort 2. Data on sunburns was not collected for the other arms.

Participant Reported Sunburns Prior to Intervention and During the Intervention

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.

31 subjects

First cohort study: It is expected that each of 31 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).

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.

Cohort Study 1-Arm 1

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).

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.

Cohort Study 1- Arm 2

31 subjects

First cohort study: It is expected that each of 31 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 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 receive structured (select strategies from a list of 7 items)

Cohort Study 1- Arm 1

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 unstructured (submit a free text description of a strategy) goal attainment.

Spots Global Cancer Trial Database for UV Exposure Assessed With Wearable Sensor and Sun Protection

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