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Melanoma (Skin Cancer)SESAMENCT07556380

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

A study testing UV Real-Time Alerts, Track Your Sun Protection and Current Conditions in people with Melanoma (Skin Cancer), run by Northwestern University at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin Cancer)
What is being tested?
UV Real-Time Alerts, Track Your Sun Protection and Current Conditions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
2 sitesUnited States
Study dates
1 Apr 2025to 1 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Northwestern University

    Chicago, Illinois, 60611

  • Huntsman Cancer Institute at The University of Utah

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: SESAME: 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.

Being tested
UV Real-Time Alerts, Track Your Sun Protection, Current Conditions, Health Coaching, Action Planning
Keywords
Wearable, Smartphone, Device, Melanoma, Physical activity, Cancer, Actigraph, Sun protection, Sunscreen, Goals, Health, Ultraviolet radiation
Medical subject headings
Melanoma, Motor Activity, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UV Real-Time AlertsBehavioural

    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 ProtectionBehavioural

    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 ConditionsBehavioural

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

  • Health CoachingBehavioural

    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 PlanningBehavioural

    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 ComponentsBehavioural

    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.

Study groups in NCT07556380
Study groupRoleWhat they receive
Experimental Condition 1ExperimentalResearch participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Health Coaching + Action Planning
Receives: Behavioral: UV Real-Time Alerts; Behavioral: Track Your Sun Protection; Behavioral: Current Conditions; Behavioral: Health Coaching; Behavioral: Action Planning; Behavioral: Core Components
Experimental Condition 2ExperimentalResearch participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Health Coaching
Receives: Behavioral: UV Real-Time Alerts; Behavioral: Track Your Sun Protection; Behavioral: Current Conditions; Behavioral: Health Coaching; Behavioral: Core Components
Experimental Condition 3ExperimentalResearch participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Action Planning
Receives: Behavioral: UV Real-Time Alerts; Behavioral: Track Your Sun Protection; Behavioral: Current Conditions; Behavioral: Action Planning; Behavioral: Core Components
Experimental Condition 4ExperimentalResearch participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions
Receives: Behavioral: UV Real-Time Alerts; Behavioral: Track Your Sun Protection; Behavioral: Current Conditions; Behavioral: Core Components
Experimental Condition 5ExperimentalResearch participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Health Coaching + Action Planning
Receives: Behavioral: UV Real-Time Alerts; Behavioral: Track Your Sun Protection; Behavioral: Health Coaching; Behavioral: Action Planning; Behavioral: Core Components
Experimental Condition 6ExperimentalResearch participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Health Coaching
Receives: Behavioral: UV Real-Time Alerts; Behavioral: Track Your Sun Protection; Behavioral: Health Coaching; Behavioral: Core Components
Experimental Condition 7ExperimentalResearch participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Action Planning
Receives: Behavioral: UV Real-Time Alerts; Behavioral: Track Your Sun Protection; Behavioral: Action Planning; Behavioral: Core Components
Experimental Condition 8ExperimentalResearch participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection
Receives: Behavioral: UV Real-Time Alerts; Behavioral: Track Your Sun Protection; Behavioral: Core Components
Experimental Condition 9ExperimentalResearch participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Health Coaching + Action Planning
Receives: Behavioral: UV Real-Time Alerts; Behavioral: Current Conditions; Behavioral: Health Coaching; Behavioral: Action Planning; Behavioral: Core Components
Experimental Condition 10ExperimentalResearch participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Health Coaching
Receives: Behavioral: UV Real-Time Alerts; Behavioral: Current Conditions; Behavioral: Health Coaching; Behavioral: Core Components
Experimental Condition 11ExperimentalResearch participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Action Planning
Receives: Behavioral: UV Real-Time Alerts; Behavioral: Current Conditions; Behavioral: Action Planning; Behavioral: Core Components
Experimental Condition 12ExperimentalResearch participant receives the Core Components + UV Real-Time Alerts + Current Conditions
Receives: Behavioral: UV Real-Time Alerts; Behavioral: Current Conditions; Behavioral: Core Components
Experimental Condition 13ExperimentalResearch participant receives the Core Components + UV Real-Time Alerts + Health Coaching + Action Planning
Receives: Behavioral: UV Real-Time Alerts; Behavioral: Health Coaching; Behavioral: Action Planning; Behavioral: Core Components
Experimental Condition 14ExperimentalResearch participant receives the Core Components + UV Real-Time Alerts + Health Coaching
Receives: Behavioral: UV Real-Time Alerts; Behavioral: Health Coaching; Behavioral: Core Components
Experimental Condition 15ExperimentalResearch participant receives the Core Components + UV Real-Time Alerts + Action Planning
Receives: Behavioral: UV Real-Time Alerts; Behavioral: Action Planning; Behavioral: Core Components
Experimental Condition 16ExperimentalResearch participant receives the Core Components + UV Real-Time Alerts
Receives: Behavioral: UV Real-Time Alerts; Behavioral: Core Components
Experimental Condition 17ExperimentalResearch participant receives the Core Components + Track Your Sun Protection + Current Conditions + Health Coaching + Action Planning
Receives: Behavioral: Track Your Sun Protection; Behavioral: Current Conditions; Behavioral: Health Coaching; Behavioral: Action Planning; Behavioral: Core Components
Experimental Condition 18ExperimentalResearch participant receives the Core Components + Track Your Sun Protection + Current Conditions + Health Coaching
Receives: Behavioral: Track Your Sun Protection; Behavioral: Current Conditions; Behavioral: Health Coaching; Behavioral: Core Components
Experimental Condition 19ExperimentalResearch participant receives the Core Components + Track Your Sun Protection + Current Conditions + Action Planning
Receives: Behavioral: Track Your Sun Protection; Behavioral: Current Conditions; Behavioral: Action Planning; Behavioral: Core Components
Experimental Condition 20ExperimentalResearch participant receives the Core Components + Track Your Sun Protection + Current Conditions
Receives: Behavioral: Track Your Sun Protection; Behavioral: Current Conditions; Behavioral: Core Components
Experimental Condition 21ExperimentalResearch participant receives the Core Components + Track Your Sun Protection + Health Coaching + Action Planning
Receives: Behavioral: Track Your Sun Protection; Behavioral: Health Coaching; Behavioral: Action Planning; Behavioral: Core Components
Experimental Condition 22ExperimentalResearch participant receives the Core Components + Track Your Sun Protection + Health Coaching
Receives: Behavioral: Track Your Sun Protection; Behavioral: Health Coaching; Behavioral: Core Components
Experimental Condition 23ExperimentalResearch participant receives the Core Components + Track Your Sun Protection + Action Planning
Receives: Behavioral: Track Your Sun Protection; Behavioral: Action Planning; Behavioral: Core Components
Experimental Condition 24ExperimentalResearch participant receives the Core Components + Track Your Sun Protection
Receives: Behavioral: Track Your Sun Protection; Behavioral: Core Components
Experimental Condition 25ExperimentalResearch participant receives the Core Components + Current Conditions + Health Coaching + Action Planning
Receives: Behavioral: Current Conditions; Behavioral: Health Coaching; Behavioral: Action Planning; Behavioral: Core Components
Experimental Condition 26ExperimentalResearch participant receives the Core Components + Current Conditions + Health Coaching
Receives: Behavioral: Current Conditions; Behavioral: Health Coaching; Behavioral: Core Components
Experimental Condition 27ExperimentalResearch participant receives the Core Components + Current Conditions + Action Planning
Receives: Behavioral: Current Conditions; Behavioral: Action Planning; Behavioral: Core Components
Experimental Condition 28ExperimentalResearch participant receives the Core Components + Current Conditions
Receives: Behavioral: Current Conditions; Behavioral: Core Components
Experimental Condition 29ExperimentalResearch participant receives the Core Components + Health Coaching + Action Planning
Receives: Behavioral: Health Coaching; Behavioral: Action Planning; Behavioral: Core Components
Experimental Condition 30ExperimentalResearch participant receives the Core Components + Health Coaching
Receives: Behavioral: Health Coaching; Behavioral: Core Components
Experimental Condition 31ExperimentalResearch participant receives the Core Components + Action Planning
Receives: Behavioral: Action Planning; Behavioral: Core Components
Experimental Condition 32ExperimentalResearch participant receives the Core Components only
Receives: Behavioral: Core Components

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Intervention period (weeks 2-9)

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

Secondary outcomes (3)
  1. 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.

    Measured: Intervention period (weeks 2-9)

  2. 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.

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

  3. 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.

    Measured: Post-assessment week 2 (2.5 months later)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2026
  2. Study start1 Apr 2025
  3. Primary completion20 Nov 2026 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Model description
Full-factorial 2 (ON/OFF) \^ 5 (Intervention Component) design. Participants are randomly assigned to 1 of 32 experimental conditions, thereby experiencing up to 5 sun protection interventions.
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07556380
Sponsor's protocol ID
IRB_00174538
Other IDs
1R34CA283480-01
Acronym
SESAME
Status last verified
Oct 2026
First submitted
9 Apr 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing UV Real-Time Alerts, Track Your Sun Protection and Current Conditions in people with Melanoma (Skin Cancer), run by Northwestern University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: Retention Rates (time frame: Intervention period (weeks 2-9)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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