Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions (SESAME)
Status
Enrolling
Conditions
Melanoma (Skin Cancer)
Treatments
Behavioral: Current Conditions
Behavioral: Action Planning
Behavioral: Core Components
Behavioral: Track Your Sun Protection
Behavioral: UV Real-Time Alerts
Behavioral: Health Coaching
Study type
Interventional
Funder types
Other
NIH
Identifiers
Details and patient eligibility
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. 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.
Enrollment
150 estimated patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Factorial Assignment
Masking
None (Open label)
150 participants in 32 patient groups
Experimental Condition 1
Experimental group
Description:
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Health Coaching + Action Planning
Treatment:
Behavioral: Health Coaching
Behavioral: Track Your Sun Protection
Behavioral: UV Real-Time Alerts
Behavioral: Core Components
Behavioral: Action Planning
Behavioral: Current Conditions
Experimental Condition 2
Experimental group
Description:
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Health Coaching
Treatment:
Behavioral: Health Coaching
Behavioral: Track Your Sun Protection
Behavioral: UV Real-Time Alerts
Behavioral: Core Components
Behavioral: Current Conditions
Experimental Condition 3
Experimental group
Description:
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Action Planning
Treatment:
Behavioral: Track Your Sun Protection
Behavioral: UV Real-Time Alerts
Behavioral: Core Components
Behavioral: Action Planning
Behavioral: Current Conditions
Experimental Condition 4
Experimental group
Description:
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions
Treatment:
Behavioral: Track Your Sun Protection
Behavioral: UV Real-Time Alerts
Behavioral: Core Components
Behavioral: Current Conditions
Experimental Condition 5
Experimental group
Description:
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Health Coaching + Action Planning
Treatment:
Behavioral: Health Coaching
Behavioral: Track Your Sun Protection
Behavioral: UV Real-Time Alerts
Behavioral: Core Components
Behavioral: Action Planning
Experimental Condition 6
Experimental group
Description:
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Health Coaching
Treatment:
Behavioral: Health Coaching
Behavioral: Track Your Sun Protection
Behavioral: UV Real-Time Alerts
Behavioral: Core Components
Experimental Condition 7
Experimental group
Description:
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Action Planning
Treatment:
Behavioral: Track Your Sun Protection
Behavioral: UV Real-Time Alerts
Behavioral: Core Components
Behavioral: Action Planning
Experimental Condition 8
Experimental group
Description:
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection
Treatment:
Behavioral: Track Your Sun Protection
Behavioral: UV Real-Time Alerts
Behavioral: Core Components
Experimental Condition 9
Experimental group
Description:
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Health Coaching + Action Planning
Treatment:
Behavioral: Health Coaching
Behavioral: UV Real-Time Alerts
Behavioral: Core Components
Behavioral: Action Planning
Behavioral: Current Conditions
Experimental Condition 10
Experimental group
Description:
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Health Coaching
Treatment:
Behavioral: Health Coaching
Behavioral: UV Real-Time Alerts
Behavioral: Core Components
Behavioral: Current Conditions
Experimental Condition 11
Experimental group
Description:
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Action Planning
Treatment:
Behavioral: UV Real-Time Alerts
Behavioral: Core Components
Behavioral: Action Planning
Behavioral: Current Conditions
Experimental Condition 12
Experimental group
Description:
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions
Treatment:
Behavioral: UV Real-Time Alerts
Behavioral: Core Components
Behavioral: Current Conditions
Experimental Condition 13
Experimental group
Description:
Research participant receives the Core Components + UV Real-Time Alerts + Health Coaching + Action Planning
Treatment:
Behavioral: Health Coaching
Behavioral: UV Real-Time Alerts
Behavioral: Core Components
Behavioral: Action Planning
Experimental Condition 14
Experimental group
Description:
Research participant receives the Core Components + UV Real-Time Alerts + Health Coaching
Treatment:
Behavioral: Health Coaching
Behavioral: UV Real-Time Alerts
Behavioral: Core Components
Experimental Condition 15
Experimental group
Description:
Research participant receives the Core Components + UV Real-Time Alerts + Action Planning
Treatment:
Behavioral: UV Real-Time Alerts
Behavioral: Core Components
Behavioral: Action Planning
Experimental Condition 16
Experimental group
Description:
Research participant receives the Core Components + UV Real-Time Alerts
Treatment:
Behavioral: UV Real-Time Alerts
Behavioral: Core Components
Experimental Condition 17
Experimental group
Description:
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Health Coaching + Action Planning
Treatment:
Behavioral: Health Coaching
Behavioral: Track Your Sun Protection
Behavioral: Core Components
Behavioral: Action Planning
Behavioral: Current Conditions
Experimental Condition 18
Experimental group
Description:
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Health Coaching
Treatment:
Behavioral: Health Coaching
Behavioral: Track Your Sun Protection
Behavioral: Core Components
Behavioral: Current Conditions
Experimental Condition 19
Experimental group
Description:
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Action Planning
Treatment:
Behavioral: Track Your Sun Protection
Behavioral: Core Components
Behavioral: Action Planning
Behavioral: Current Conditions
Experimental Condition 20
Experimental group
Description:
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions
Treatment:
Behavioral: Track Your Sun Protection
Behavioral: Core Components
Behavioral: Current Conditions
Experimental Condition 21
Experimental group
Description:
Research participant receives the Core Components + Track Your Sun Protection + Health Coaching + Action Planning
Treatment:
Behavioral: Health Coaching
Behavioral: Track Your Sun Protection
Behavioral: Core Components
Behavioral: Action Planning
Experimental Condition 22
Experimental group
Description:
Research participant receives the Core Components + Track Your Sun Protection + Health Coaching
Treatment:
Behavioral: Health Coaching
Behavioral: Track Your Sun Protection
Behavioral: Core Components
Experimental Condition 23
Experimental group
Description:
Research participant receives the Core Components + Track Your Sun Protection + Action Planning
Treatment:
Behavioral: Track Your Sun Protection
Behavioral: Core Components
Behavioral: Action Planning
Experimental Condition 24
Experimental group
Description:
Research participant receives the Core Components + Track Your Sun Protection
Treatment:
Behavioral: Track Your Sun Protection
Behavioral: Core Components
Experimental Condition 25
Experimental group
Description:
Research participant receives the Core Components + Current Conditions + Health Coaching + Action Planning
Treatment:
Behavioral: Health Coaching
Behavioral: Core Components
Behavioral: Action Planning
Behavioral: Current Conditions
Experimental Condition 26
Experimental group
Description:
Research participant receives the Core Components + Current Conditions + Health Coaching
Treatment:
Behavioral: Health Coaching
Behavioral: Core Components
Behavioral: Current Conditions
Experimental Condition 27
Experimental group
Description:
Research participant receives the Core Components + Current Conditions + Action Planning
Treatment:
Behavioral: Core Components
Behavioral: Action Planning
Behavioral: Current Conditions
Experimental Condition 28
Experimental group
Description:
Research participant receives the Core Components + Current Conditions
Treatment:
Behavioral: Core Components
Behavioral: Current Conditions
Experimental Condition 29
Experimental group
Description:
Research participant receives the Core Components + Health Coaching + Action Planning
Treatment:
Behavioral: Health Coaching
Behavioral: Core Components
Behavioral: Action Planning
Experimental Condition 30
Experimental group
Description:
Research participant receives the Core Components + Health Coaching
Treatment:
Behavioral: Health Coaching
Behavioral: Core Components
Experimental Condition 31
Experimental group
Description:
Research participant receives the Core Components + Action Planning
Treatment:
Behavioral: Core Components
Behavioral: Action Planning
Experimental Condition 32
Experimental group
Description:
Research participant receives the Core Components only
Treatment:
Behavioral: Core Components
Trial contacts and locations
2
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Central trial contact
Nabil Alshurafa, PhD; Bonnie Nolan
Data sourced from clinicaltrials.gov
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