Melanoma (Skin Cancer)
Conditions
Keywords
Wearable, Smartphone, Device, Melanoma, Physical activity, Cancer, Actigraph, Sun protection, Sunscreen, Goals, Health, Ultraviolet radiation
Brief 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 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
BEHAVIORALUV 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.
BEHAVIORALTrack 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.
BEHAVIORALCurrent Conditions
This displays a participant's location's UVR index and notifies them of ultraviolet radiation forecasts for different times throughout the day.
BEHAVIORALHealth 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.
BEHAVIORALAction 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.
BEHAVIORALCore 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.
Sponsors
Northwestern University
National Institutes of Health (NIH)
Huntsman Cancer Institute/ University of Utah
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Retention Rates | 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Response Rates to Intervention Components | 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. |
| Sunburns | 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. |
| Usability, Burden, and Acceptability Self-Reports | 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. |
Countries
United States
Contacts
CONTACTNabil Alshurafa, PhD
CONTACTBonnie Nolan
PRINCIPAL_INVESTIGATORNabil Alshurafa, PhD
Northwestern University
PRINCIPAL_INVESTIGATORTammy Stump, PhD
Huntsman Cancer Institute at The University of Utah
Outcome results
None listed