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NCT Number: NCT07556380

Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions

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.

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Key information

Conditions

Melanoma (Skin Cancer) Behavior Melanoma Motor Activity Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UV Real-Time Alerts

Behavioral

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.

Track Your Sun Protection

Behavioral

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.

Current Conditions

Behavioral

This displays a participant's location's UVR index and notifies them of ultraviolet radiation forecasts for different times throughout the day.

Health Coaching

Behavioral

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.

Action Planning

Behavioral

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.

Core Components

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Feasibility: Response Rates to Intervention Components

    Time frame: Intervention period (weeks 2-9)

    Response (engagement) rates will be calculated separately for each intervention type, with denominator varying by intervention, based on number of engagement opportunities.

  2. Sunburns

    Time frame: 1-week bursts at baseline, post-intervention (2 months later), and 12 months post baseline.

    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.

  3. Usability, Burden, and Acceptability Self-Reports

    Time frame: Post-assessment week 2 (2.5 months later)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bonnie Nolan

CONTACT

[email protected]

312-503-1216

Nabil Alshurafa, PhD

CONTACT

[email protected]

312-503-4517

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Huntsman Cancer Institute/ University of Utah
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

SESAME: Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions

Acronym: SESAME

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 29, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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