NCT07556380 · Northwestern University
Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions
(SESAME)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
UV Real-Time Alerts
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.
BEHAVIORAL
Track Your Sun Protection
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.
BEHAVIORAL
Current Conditions
This displays a participant's location's UVR index and notifies them of ultraviolet radiation forecasts for different times throughout the day.
BEHAVIORAL
Health Coaching
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.
BEHAVIORAL
Action Planning
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.
BEHAVIORAL
Core Components
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.
Primary outcome measures
Feasibility: Retention Rates
Time frame: Intervention period (weeks 2-9)
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.
Feasibility: Completion of Daily Assessment Week Surveys
Time frame: 1-week bursts at baseline, post-intervention (2 months later) and 12 months post baseline.
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.
Feasibility: Completion of Pre-Assessment Week Surveys
Time frame: 1-week bursts at baseline, post-intervention (2 months later) and 12 months post baseline.
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.
Feasibility: Weekly Device Wear
Time frame: 1-week bursts at baseline, post-intervention (2 months later) and 12 months post baseline.
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.
Unprotected Sun Exposure
Time frame: 1-week bursts at baseline, post-intervention (2 months later), and 12 months post baseline.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Is able to speak, read and write in English
- Had previous melanoma diagnosis with no melanoma treatment in the last three months
- Has no current Melanomas or untreated skin cancer
- Reports spending at least 15 minutes outside per day during Spring/ Summer on both weekdays and weekends
- Owns a smartphone with access to both Bluetooth and WIFI
- Is willing to use the UV device and Actigraph during waking hours
- Is willing to download and use a study app
- Is willing to actively participate in the study for up to 1 year
Exclusion criteria
- Has a medical condition preventing moderate-to-vigorous physical activity (MVPA) or a doctor recommendation to avoid MVPA
- Is currently enrolled in another study on MVPA
Where
- Chicago, Illinois
- Salt Lake City, Utah
Collaborators
National Institutes of Health (NIH), Huntsman Cancer Institute, National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations