NCT03344796

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

June 30, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

July 27, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

2.3 years

First QC Date

October 26, 2017

Results QC Date

October 27, 2022

Last Update Submit

July 5, 2023

Conditions

Sunburn, ErythemaSun Protection

Keywords

Skin CancerSunburn, erythemaUV Exposure, SunburnWearable UV Device

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Sun Exposure in Participants With Structured vs Unstructured Goal Setting

    21 days

Other Outcomes (2)

  • Participant Reported Sunburns Prior to Intervention and During the Intervention

    56 days

  • Knowledge of Sun Protection

    2 months

Study Arms (6)

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.

Behavioral: Goal attainment

Structured Interviews

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.

Behavioral: Goal attainment

Interventions

Goal attainmentBEHAVIORAL

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 2Cohort Study 1-Arm 1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • history of Stage 0 to IIB melanoma treated within the last five years, age 18-70 years old
  • have a smartphone
  • familiarity with use of mobile apps
  • have skin type 1-3
  • willing to wear the sensor and able to transmit data which requires Wi-Fi in the home
  • Come to the Chicago campus of the medical school

You may not qualify if:

  • Cohort Study 2: Young adults with sun sensitive skin
  • history of sun sensitive skin, skin type 1-3
  • have a smartphone and willing to use the UV guard application on the smartphone
  • reliable wireless internet connection to complete daily surveys
  • willing to wear the sensor for 28 days and transmit data and complete daily surveys
  • willing to receive SMS text messages on their personal phone and potentially sync sensor to personal phone using Bluetooth
  • 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
  • unable to speak English
  • lacking a secure Internet connection or very little experience with smartphones and mobile applications .
  • unable to walk inside and outside independently
  • unable to be outdoors for at least one hour each day (weather permitting)
  • unable to be outdoors for 30 consecutive minutes a day between 8 AM and 5 PM.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Related Publications (3)

  • 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.

    PMID: 33185716RESULT

  • 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.

    PMID: 30116702RESULT

  • 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.

    PMID: 33955844DERIVED

MeSH Terms

Conditions

SunburnErythemaSkin Neoplasms

Condition Hierarchy (Ancestors)

Photosensitivity DisordersSkin DiseasesSkin and Connective Tissue DiseasesBurnsWounds and InjuriesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasms

Results Point of Contact

Title
Dr. June Robinson
Organization
Northwestern Univ
june-robinson@northwestern.edu
312-503-5941

Study Officials

  • June K. Robinson, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
cohort study 1 and 2 were masked. Each participant was identified by a study number assigned in REDCap
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

October 26, 2017

First Posted

November 17, 2017

Study Start

June 30, 2018

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

July 27, 2023

Results First Posted

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)