Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions
ConditionMelanoma (Skin Cancer)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Factorial
Treatments tested in this trial
UV Real-Time Alerts
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralThis displays a participant's location's UVR index and notifies them of ultraviolet radiation forecasts for different times throughout the day.
Health Coaching
BehavioralBi-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
BehavioralParticipants 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
BehavioralAll 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.
Treatment groups
150 Participants
are divided into 32 treatment groups32
Treatment groupsSee each treatment group below.
Group A: Experimental Condition 1Experimental treatment 6 interventions
Group B: Experimental Condition 2Experimental treatment 5 interventions
Group C: Experimental Condition 3Experimental treatment 5 interventions
Group D: Experimental Condition 4Experimental treatment 4 interventions
Group E: Experimental Condition 5Experimental treatment 5 interventions
Group F: Experimental Condition 6Experimental treatment 4 interventions
Group G: Experimental Condition 7Experimental treatment 4 interventions
Group H: Experimental Condition 8Experimental treatment 3 interventions
Group I: Experimental Condition 9Experimental treatment 5 interventions
Group J: Experimental Condition 10Experimental treatment 4 interventions
Group K: Experimental Condition 11Experimental treatment 4 interventions
Group L: Experimental Condition 12Experimental treatment 3 interventions
Group M: Experimental Condition 13Experimental treatment 4 interventions
Group N: Experimental Condition 14Experimental treatment 3 interventions
Group O: Experimental Condition 15Experimental treatment 3 interventions
Group P: Experimental Condition 16Experimental treatment 2 interventions
Group Q: Experimental Condition 17Experimental treatment 5 interventions
Group R: Experimental Condition 18Experimental treatment 4 interventions
Group S: Experimental Condition 19Experimental treatment 4 interventions
Group T: Experimental Condition 20Experimental treatment 3 interventions
Group U: Experimental Condition 21Experimental treatment 4 interventions
Group V: Experimental Condition 22Experimental treatment 3 interventions
Group W: Experimental Condition 23Experimental treatment 3 interventions
Group X: Experimental Condition 24Experimental treatment 2 interventions
Group Y: Experimental Condition 25Experimental treatment 4 interventions
Group Z: Experimental Condition 26Experimental treatment 3 interventions
Group [: Experimental Condition 27Experimental treatment 3 interventions
Group \: Experimental Condition 28Experimental treatment 2 interventions
Group ]: Experimental Condition 29Experimental treatment 3 interventions
Group ^: Experimental Condition 30Experimental treatment 2 interventions
Group _: Experimental Condition 31Experimental treatment 2 interventions
Group `: Experimental Condition 32Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
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.
Time frame
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.
Time frame
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.
Time frame
1-week bursts at baseline, post-intervention (2 months later) and 12 months post baseline.Secondary outcomes
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.
Time frame
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.
Time frame
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.
Time frame
Post-assessment week 2 (2.5 months later)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Northwestern University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Huntsman Cancer Institute/ University of Utah
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov