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| ID | Type | Description | Link |
|---|---|---|---|
| R44CA224658 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focus Group | No Intervention | 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 | 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 | 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. |
|
| Structured Interviews |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goal attainment | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | cohort study 1 (arms 1 and 2) at end of 21 days, cohort study 2 (only one arm) at end of 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 56 days |
| Knowledge of Sun Protection |
Cohort Study 1:
Inclusion Criteria:
Exclusion Criteria:
-
Cohort Study 2: Young adults with sun sensitive skin
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| June K. Robinson, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine Department of Dermatology | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33185716 | Result | 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. | |
| 30116702 | Result | 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. |
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After subject meets eligibility requirements and is enrolled they are assigned to an arm without a run-in or wash-out.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Cohort Study 1- Arm 1 | 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) |
| FG003 | Cohort Study 1 Arm 2 | 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. |
| FG004 | 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. |
| FG005 | Cohort Study 2 | Second cohort study: 42 young adults will wear the sensor and transmit data for 28 days in summer 2020. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Focus groups and structured interviews did not have data collected for acceptability of wearing the UV sensor and receiving text messages. | Posted | Mean | Standard Deviation | score on a scale | cohort study 1 (arms 1 and 2) at end of 21 days, cohort study 2 (only one arm) at end of 28 days |
|
1 year
Focus groups and structured interviews which involve talking with subjects have no risk of adverse medical events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. June Robinson | Northwestern Univ | 312-503-5941 | june-robinson@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2019 | Apr 1, 2019 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 11, 2019 | Apr 1, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013471 | Sunburn |
| D004890 | Erythema |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D010787 | Photosensitivity Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002056 | Burns |
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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
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cohort study 1 and 2 were masked. Each participant was identified by a study number assigned in REDCap
| No 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. |
| Cohort Study 2 | No Intervention | 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 | 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. |
|
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. |
| 2 months |
| 33955844 | Derived | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Knowledge of Sun Protection | 9 item scale (Minimum= 9, Maximum=18) Total range is9-18. Higher value is better knowledge and a better outcome. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Cohort Study 1 Arm1 | 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. |
| OG002 | Cohort Study 1 Arm 2 | 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. |
| OG003 | Cohort Study 2 | Second cohort study: 42 young adults will wear the sensor and transmit data for 28 days in summer 2020. |
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | J/m^2/day | 21 days |
|
|
|
|
| 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. | This is a single arm study for cohort 2. Data on sunburns was not collected for the other arms. | Posted | Number | participants | 56 days |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 2 months |
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|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Cohort Study 1-arm 1 | 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. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG003 | Cohort Study 1-arm 2 | 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). | 0 | 29 | 0 | 29 | 0 | 29 |
| EG004 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG005 | Cohort Study 2 | Second cohort study: 42 young adults will wear the sensor and transmit data for 28 days in summer 2020. | 0 | 42 | 0 | 42 | 0 | 42 |
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| D014947 |
| Wounds and Injuries |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |