- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07556380
Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions (SESAME)
April 22, 2026 updated by: Nabil Alshurafa, Northwestern University
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.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nabil Alshurafa, PhD
- Phone Number: 312-503-4517
- Email: nabil@northwestern.edu
Study Contact Backup
- Name: Bonnie Nolan
- Phone Number: 312-503-1216
- Email: bonnie.nolan@northwestern.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
Contact:
- Nabil Alshurafa, PhD
- Phone Number: 3125034517
- Email: nabil@northwestern.edu
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute at the University of Utah
-
Contact:
- Tammy Stump, PhD
- Phone Number: 801-646-4201
- Email: tammy.stump@hci.utah.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Condition 1
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Health Coaching + Action Planning
|
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.
|
|
Experimental: Experimental Condition 2
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Health Coaching
|
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.
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.
|
|
Experimental: Experimental Condition 3
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Action Planning
|
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.
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.
|
|
Experimental: Experimental Condition 4
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions
|
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.
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.
|
|
Experimental: Experimental Condition 5
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Health Coaching + Action Planning
|
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.
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.
|
|
Experimental: Experimental Condition 6
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Health Coaching
|
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.
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.
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.
|
|
Experimental: Experimental Condition 7
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Action Planning
|
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.
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.
|
|
Experimental: Experimental Condition 8
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection
|
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.
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.
|
|
Experimental: Experimental Condition 9
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Health Coaching + Action Planning
|
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.
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.
|
|
Experimental: Experimental Condition 10
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Health Coaching
|
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.
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.
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.
|
|
Experimental: Experimental Condition 11
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Action Planning
|
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.
This displays a participant's location's UVR index and notifies them of ultraviolet radiation forecasts for different times throughout the day.
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.
|
|
Experimental: Experimental Condition 12
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions
|
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.
This displays a participant's location's UVR index and notifies them of ultraviolet radiation forecasts for different times throughout the day.
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.
|
|
Experimental: Experimental Condition 13
Research participant receives the Core Components + UV Real-Time Alerts + Health Coaching + Action Planning
|
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.
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.
|
|
Experimental: Experimental Condition 14
Research participant receives the Core Components + UV Real-Time Alerts + Health Coaching
|
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.
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.
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.
|
|
Experimental: Experimental Condition 15
Research participant receives the Core Components + UV Real-Time Alerts + Action Planning
|
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 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.
|
|
Experimental: Experimental Condition 16
Research participant receives the Core Components + 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.
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.
|
|
Experimental: Experimental Condition 17
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Health Coaching + Action Planning
|
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.
|
|
Experimental: Experimental Condition 18
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Health Coaching
|
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.
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.
|
|
Experimental: Experimental Condition 19
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Action Planning
|
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.
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.
|
|
Experimental: Experimental Condition 20
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions
|
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.
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.
|
|
Experimental: Experimental Condition 21
Research participant receives the Core Components + Track Your Sun Protection + Health Coaching + Action Planning
|
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.
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.
|
|
Experimental: Experimental Condition 22
Research participant receives the Core Components + Track Your Sun Protection + Health Coaching
|
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.
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.
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.
|
|
Experimental: Experimental Condition 23
Research participant receives the Core Components + Track Your Sun Protection + Action Planning
|
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.
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.
|
|
Experimental: Experimental Condition 24
Research participant receives the Core Components + 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.
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.
|
|
Experimental: Experimental Condition 25
Research participant receives the Core Components + Current Conditions + Health Coaching + Action Planning
|
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.
|
|
Experimental: Experimental Condition 26
Research participant receives the Core Components + Current Conditions + Health Coaching
|
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.
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.
|
|
Experimental: Experimental Condition 27
Research participant receives the Core Components + Current Conditions + Action Planning
|
This displays a participant's location's UVR index and notifies them of ultraviolet radiation forecasts for different times throughout the day.
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.
|
|
Experimental: Experimental Condition 28
Research participant receives the Core Components + Current Conditions
|
This displays a participant's location's UVR index and notifies them of ultraviolet radiation forecasts for different times throughout the day.
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.
|
|
Experimental: Experimental Condition 29
Research participant receives the Core Components + Health Coaching + Action Planning
|
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.
|
|
Experimental: Experimental Condition 30
Research participant receives the Core Components + 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.
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.
|
|
Experimental: Experimental Condition 31
Research participant receives the Core Components + 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.
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.
|
|
Experimental: Experimental Condition 32
Research participant receives the Core Components only
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Intervention period (weeks 2-9)
|
|
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. |
1-week bursts at baseline, post-intervention (2 months later) and 12 months post baseline.
|
|
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.
|
1-week bursts at baseline, post-intervention (2 months later) and 12 months post baseline.
|
|
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.
|
1-week bursts at baseline, post-intervention (2 months later) and 12 months post baseline.
|
|
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.
|
1-week bursts at baseline, post-intervention (2 months later), and 12 months post baseline.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Intervention period (weeks 2-9)
|
|
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.
|
1-week bursts at baseline, post-intervention (2 months later), and 12 months post baseline.
|
|
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.
|
Post-assessment week 2 (2.5 months later)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nabil Alshurafa, PhD, Northwestern University
- Principal Investigator: Tammy Stump, PhD, Huntsman Cancer Institute at the University of Utah
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2026
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
September 1, 2027
Study Registration Dates
First Submitted
April 9, 2026
First Submitted That Met QC Criteria
April 22, 2026
First Posted (Actual)
April 29, 2026
Study Record Updates
Last Update Posted (Actual)
April 29, 2026
Last Update Submitted That Met QC Criteria
April 22, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB_00174538
- 1R34CA283480-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Universitaire Ziekenhuizen KU LeuvenRecruitingSkin Cancer, Non-Melanoma | Skin Cancer MelanomaBelgium
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Oncovir, Inc.National Cancer Institute (NCI); University of Missouri-Columbia; Icahn School... and other collaboratorsCompletedMelanoma | Sarcoma | Head and Neck Cancer | Non-Melanoma Skin CancersUnited States
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Iovance Biotherapeutics, Inc.Active, not recruitingMetastatic Melanoma | Unresectable Melanoma | Melanoma (Skin Cancer)United States, United Kingdom, Australia, Canada
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI); University of VirginiaCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage III Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin Melanoma | Stage 0 Skin Melanoma | Stage I Skin Melanoma | Stage II Skin MelanomaUnited States
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Linnaeus Therapeutics, Inc.Merck Sharp & Dohme LLCRecruitingUnresectable Melanoma | Cutaneous Melanoma | Melanoma (Skin Cancer) | Melanoma Stage IIIB-IVUnited States
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William CarsonSchering-PloughCompletedStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin MelanomaUnited States
Clinical Trials on UV Real-Time Alerts
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Rigshospitalet, DenmarkHvidovre University Hospital; Bispebjerg HospitalRecruitingPostoperative Complications | Cancer, Treatment-RelatedDenmark
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Rigshospitalet, DenmarkOdense University Hospital; Danish Cancer Society; Herlev Hospital; Aalborg University...Completed
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Keller Army Community HospitalRecruitingHealthy RunnersUnited States
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Chung Shan Medical UniversityNot yet recruitingAnxiety | Adherence | Chemoradiotherapy | Radiation TherapyTaiwan
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University of North Carolina, Chapel HillArthritis FoundationRecruitingKnee Osteoarthritis | Osteo Arthritis Knee | Post-traumatic Osteoarthritis | Anterior Cruciate Ligament Injuries | Knee Injuries | Gait | Cartilage, ArticularUnited States
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University of North Carolina, Chapel HillArthritis FoundationCompletedKnee Osteoarthritis | Post-traumatic Osteoarthritis | Anterior Cruciate Ligament Injuries | Knee Injuries | Gait | Cartilage, ArticularUnited States
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Icahn School of Medicine at Mount SinaiNational Institute on Drug Abuse (NIDA)CompletedSubstance Use Disorder | Opioid Use Disorder | Heroin Use DisorderUnited States
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Trustees of Princeton UniversityNational Institute of Mental Health (NIMH)Recruiting
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Kymberly YoungNational Institute of Mental Health (NIMH)Terminated
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Laureate Institute for Brain Research, Inc.National Institute of Mental Health (NIMH)CompletedMajor Depressive DisorderUnited States