Trial Outcomes & Findings for UV Exposure Assessed With Wearable Sensor and Sun Protection (NCT NCT03344796)

Last Updated: 2023-07-27

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

164 participants

Primary outcome timeframe

cohort study 1 (arms 1 and 2) at end of 21 days, cohort study 2 (only one arm) at end of 28 days

Results posted on

2023-07-27

Participant Flow

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.

After subject meets eligibility requirements and is enrolled they are assigned to an arm without a run-in or wash-out.

Participant milestones

Participant milestones
Measure	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.	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.	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)	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.	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.	Cohort Study 2 Second cohort study: 42 young adults will wear the sensor and transmit data for 28 days in summer 2020.
Overall Study STARTED	32	10	31	29	20	42
Overall Study COMPLETED	32	10	31	29	20	40
Overall Study NOT COMPLETED	0	0	0	0	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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)	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.	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.	Cohort Study 2 Second cohort study: 42 young adults will wear the sensor and transmit data for 28 days in summer 2020.
Overall Study Lost to Follow-up	0	0	0	0	0	2

Baseline Characteristics

UV Exposure Assessed With Wearable Sensor and Sun Protection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Focus Group n=32 Participants 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.	Usability Testing n=10 Participants 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.	Cohort Study 1 Arm 1 n=31 Participants 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 2 n=29 Participants 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.	Structured Interviews n=20 Participants 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.	Cohort Study 2 n=42 Participants 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 n=164 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants	24 Participants n=4 Participants	20 Participants n=21 Participants	42 Participants n=8 Participants	146 Participants n=8 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	18 Participants n=8 Participants
Age, Continuous	57.4 years STANDARD_DEVIATION 11.5 • n=5 Participants	24.3 years STANDARD_DEVIATION 3.2 • n=7 Participants	59.3 years STANDARD_DEVIATION 12.5 • n=5 Participants	58.8 years STANDARD_DEVIATION 10.2 • n=4 Participants	21.2 years STANDARD_DEVIATION 1.4 • n=21 Participants	22.6 years STANDARD_DEVIATION 4.5 • n=8 Participants	48.2 years STANDARD_DEVIATION 15.7 • n=8 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants	18 Participants n=4 Participants	10 Participants n=21 Participants	28 Participants n=8 Participants	96 Participants n=8 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants	11 Participants n=4 Participants	10 Participants n=21 Participants	14 Participants n=8 Participants	68 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	7 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	9 Participants n=7 Participants	31 Participants n=5 Participants	29 Participants n=4 Participants	18 Participants n=21 Participants	36 Participants n=8 Participants	153 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants
Region of Enrollment United States	32 Participants n=5 Participants	10 Participants n=7 Participants	31 Participants n=5 Participants	29 Participants n=4 Participants	20 Participants n=21 Participants	42 Participants n=8 Participants	164 Participants n=8 Participants
Knowledge of Sun Protection	12 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants	13 units on a scale STANDARD_DEVIATION 3.1 • n=7 Participants	17 units on a scale STANDARD_DEVIATION 2.3 • n=5 Participants	18 units on a scale STANDARD_DEVIATION 1.9 • n=4 Participants	11 units on a scale STANDARD_DEVIATION 1.4 • n=21 Participants	11 units on a scale STANDARD_DEVIATION 2.1 • n=8 Participants	14 units on a scale STANDARD_DEVIATION 2.1 • n=8 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Usability Testing n=10 Participants 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.	Cohort Study 1 Arm1 n=31 Participants 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 Arm 2 n=29 Participants 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.	Cohort Study 2 n=42 Participants Second cohort study: 42 young adults will wear the sensor and transmit data for 28 days in summer 2020.	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.	Cohort Study 2 Second cohort study: 42 young adults will wear the sensor and transmit data for 28 days in summer 2020.
Acceptability of Wearing UV Sensor and Receiving Text Messages	22 score on a scale Standard Deviation 3.5	39.1 score on a scale Standard Deviation 6.2	40.1 score on a scale Standard Deviation 5.3	40.6 score on a scale Standard Deviation 2.9	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Usability Testing n=31 Participants 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.	Cohort Study 1 Arm1 n=29 Participants 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 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.	Cohort Study 2 Second cohort study: 42 young adults will wear the sensor and transmit data for 28 days in summer 2020.	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.	Cohort Study 2 Second cohort study: 42 young adults will wear the sensor and transmit data for 28 days in summer 2020.
Sun Exposure in Participants With Structured vs Unstructured Goal Setting	399.9 J/m^2/day Standard Error 10.6	196.8 J/m^2/day Standard Error 129.1	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 56 days

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

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.

Outcome measures

Outcome measures
Measure	Usability Testing n=42 Participants 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.	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.	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.	Cohort Study 2 Second cohort study: 42 young adults will wear the sensor and transmit data for 28 days in summer 2020.	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.	Cohort Study 2 Second cohort study: 42 young adults will wear the sensor and transmit data for 28 days in summer 2020.
Participant Reported Sunburns Prior to Intervention and During the Intervention Sunburns prior to intervention	30 participants	—	—	—	—	—
Participant Reported Sunburns Prior to Intervention and During the Intervention Sunburns during intervention	18 participants	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.