The purpose of this study is to evaluate 5 different smartphone administered sun protection interventions that aim to reduce unprotected sun exposure in melanoma survivors. Participants are asked to wear an ultraviolet (UV) device and an activity monitor (Actigraph) to measure their daily UV exposure and track their physical activity for three separate assessment weeks and complete daily surveys. After the first assessment week, eligible participants are assigned up to 5 different sun protection interventions that are administered through a smartphone application for 8 weeks. Following 8-week use of the sun protection interventions, participants complete another assessment week. At the end of the assessment week, participants provide feedback on the design and usability of the UV device, smartphone application and each of the sun protection interventions that they experienced. One year later, participants are contacted again to complete a final assessment week.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
150
Participants will receive text-based alerts about high-risk sun exposure as assessed by their UV device. If they are assigned this intervention, they will use a UV device.
Participants report their clothing and sunscreen use on a digital avatar each time they go outdoors. If they are assigned this intervention, they will use a UV device.
This displays a participant's location's UVR index and notifies them of ultraviolet radiation forecasts for different times throughout the day.
Bi-weekly (four times total) a trained health coach will individually call participants to discuss progress towards sun protection goals and provide support and advice. Scheduled calls, pre-interview questions, and goals will be displayed in the app.
Participants will be instructed on how to set action plans for sun protection and will receive information from a mobile app about setting plans for enacting health behaviors and counteracting barriers.
All participants receive two core components, messages and lessons. Messages delivers two helpful UV protection tips per week and lessons contains 5 UV education courses for participants to read.
Northwestern University
Chicago, Illinois, United States
Huntsman Cancer Institute at The University of Utah
Salt Lake City, Utah, United States
Feasibility: Retention Rates
Retention rates will be calculated for the overall study and separately for each component. Feasibility target: \<=30% treatment drop-out (or lost to follow-up) in at-least one treatment component. Investigators will report feasibility in aggregate and by site.
Time frame: Intervention period (weeks 2-9)
Feasibility: Completion of Daily Assessment Week Surveys
Assessment completion will be calculated for daily surveys (a combination of MUSE and device logging) completed during each assessment week. Feasibility target: \>=80% completion. Investigators will report feasibility in aggregate and by site.
Time frame: 1-week bursts at baseline, post-intervention (2 months later) and 12 months post baseline.
Feasibility: Completion of Pre-Assessment Week Surveys
Assessment completion will be calculated for the Pre-Assessment Week Survey (a combination of the Sun Habits Survey, Social Cognitive Theory Questions and Godin Leisure-Time Questionnaire) completed once at the start of each assessment week. Feasibility target: \>=80% completion. Investigators will report feasibility in aggregate and by site.
Time frame: 1-week bursts at baseline, post-intervention (2 months later) and 12 months post baseline.
Feasibility: Weekly Device Wear
Device wear will be calculated for the UVR sensor and Actigraph (number of days worn more than 8 hours at each assessment week). Feasibility target: \>=80% completion. Investigators will report feasibility in aggregate and by site.
Time frame: 1-week bursts at baseline, post-intervention (2 months later) and 12 months post baseline.
Unprotected Sun Exposure
Unprotected Sun Exposure is calculated based on a combination of self-report and sensor data. The Daily MUSE Inventory, will be used to assess sun exposure based on the outdoor activities that a participant completes. On this measure, participants first select the type, timing, and clothing worn by activity performed. Participants then report on applications of sunscreen, including time applied (or reapplied), body sites covered, and SPF. The UVR sensor will continually assess UVR dose during assessment weeks. The information from the Daily MUSE Inventory will be aligned with data from UVR sensors to generate, unprotected sun exposure, which is the UVR dose weighted by the proportion of body surface area exposed.
Time frame: 1-week bursts at baseline, post-intervention (2 months later), and 12 months post baseline.
Feasibility: Response Rates to Intervention Components
Response (engagement) rates will be calculated separately for each intervention type, with denominator varying by intervention, based on number of engagement opportunities.
Time frame: Intervention period (weeks 2-9)
Sunburns
Sunburns will be assessed using questions from the well-validated Sun Habits Survey including: "In the past month, how many times did you have a red or painful sunburn that lasted a day or more?" at the start of each of the three assessment windows.
Time frame: 1-week bursts at baseline, post-intervention (2 months later), and 12 months post baseline.
Usability, Burden, and Acceptability Self-Reports
At the end of the study, participants will complete a User Burden Scale to assess difficulty of use, physical burden, time and social burden, mental and emotional burden, and privacy burden. The System Usability Scale will also be used to assess perceptions of the overall usability of the SESAME app and interventions. At the end of the intervention, participants will be asked to complete a one-on-one interview with the research team to assess acceptability of each of the five intervention components, comfort, and wearability concerns.
Time frame: Post-assessment week 2 (2.5 months later)
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