SESAME: Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Feasibility: Retention Rates
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental Condition 2
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Health Coaching
干预措施: Track Your Sun Protection (Behavioral)
Experimental Condition 2
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Health Coaching
干预措施: Current Conditions (Behavioral)
Experimental Condition 2
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Health Coaching
干预措施: Health Coaching (Behavioral)
Experimental Condition 2
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Health Coaching
干预措施: Core Components (Behavioral)
Experimental Condition 3
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Action Planning
干预措施: Current Conditions (Behavioral)
Experimental Condition 3
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Action Planning
干预措施: UV Real-Time Alerts (Behavioral)
Experimental Condition 3
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Action Planning
干预措施: Track Your Sun Protection (Behavioral)
Experimental Condition 4
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions
干预措施: Core Components (Behavioral)
Experimental Condition 5
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Health Coaching + Action Planning
干预措施: UV Real-Time Alerts (Behavioral)
Experimental Condition 5
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Health Coaching + Action Planning
干预措施: Track Your Sun Protection (Behavioral)
Experimental Condition 6
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Health Coaching
干预措施: UV Real-Time Alerts (Behavioral)
Experimental Condition 5
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Health Coaching + Action Planning
干预措施: Health Coaching (Behavioral)
Experimental Condition 5
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Health Coaching + Action Planning
干预措施: Action Planning (Behavioral)
Experimental Condition 6
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Health Coaching
干预措施: Track Your Sun Protection (Behavioral)
Experimental Condition 6
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Health Coaching
干预措施: Health Coaching (Behavioral)
Experimental Condition 7
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Action Planning
干预措施: Track Your Sun Protection (Behavioral)
Experimental Condition 6
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Health Coaching
干预措施: Core Components (Behavioral)
Experimental Condition 7
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Action Planning
干预措施: Action Planning (Behavioral)
Experimental Condition 9
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Health Coaching + Action Planning
干预措施: Core Components (Behavioral)
Experimental Condition 10
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Health Coaching
干预措施: Current Conditions (Behavioral)
Experimental Condition 11
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Action Planning
干预措施: UV Real-Time Alerts (Behavioral)
Experimental Condition 10
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Health Coaching
干预措施: Core Components (Behavioral)
Experimental Condition 11
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Action Planning
干预措施: Current Conditions (Behavioral)
Experimental Condition 11
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Action Planning
干预措施: Action Planning (Behavioral)
Experimental Condition 12
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions
干预措施: Current Conditions (Behavioral)
Experimental Condition 13
Research participant receives the Core Components + UV Real-Time Alerts + Health Coaching + Action Planning
干预措施: Core Components (Behavioral)
Experimental Condition 14
Research participant receives the Core Components + UV Real-Time Alerts + Health Coaching
干预措施: UV Real-Time Alerts (Behavioral)
Experimental Condition 16
Research participant receives the Core Components + UV Real-Time Alerts
干预措施: UV Real-Time Alerts (Behavioral)
Experimental Condition 18
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Health Coaching
干预措施: Track Your Sun Protection (Behavioral)
Experimental Condition 17
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Health Coaching + Action Planning
干预措施: Health Coaching (Behavioral)
Experimental Condition 17
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Health Coaching + Action Planning
干预措施: Action Planning (Behavioral)
Experimental Condition 17
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Health Coaching + Action Planning
干预措施: Core Components (Behavioral)
Experimental Condition 19
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Action Planning
干预措施: Action Planning (Behavioral)
Experimental Condition 21
Research participant receives the Core Components + Track Your Sun Protection + Health Coaching + Action Planning
干预措施: Action Planning (Behavioral)
Experimental Condition 19
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Action Planning
干预措施: Core Components (Behavioral)
Experimental Condition 20
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions
干预措施: Track Your Sun Protection (Behavioral)
Experimental Condition 23
Research participant receives the Core Components + Track Your Sun Protection + Action Planning
干预措施: Action Planning (Behavioral)
Experimental Condition 24
Research participant receives the Core Components + Track Your Sun Protection
干预措施: Track Your Sun Protection (Behavioral)
Experimental Condition 25
Research participant receives the Core Components + Current Conditions + Health Coaching + Action Planning
干预措施: Current Conditions (Behavioral)
Experimental Condition 25
Research participant receives the Core Components + Current Conditions + Health Coaching + Action Planning
干预措施: Health Coaching (Behavioral)
Experimental Condition 26
Research participant receives the Core Components + Current Conditions + Health Coaching
干预措施: Current Conditions (Behavioral)
Experimental Condition 26
Research participant receives the Core Components + Current Conditions + Health Coaching
干预措施: Health Coaching (Behavioral)
Experimental Condition 29
Research participant receives the Core Components + Health Coaching + Action Planning
干预措施: Health Coaching (Behavioral)
Experimental Condition 29
Research participant receives the Core Components + Health Coaching + Action Planning
干预措施: Action Planning (Behavioral)
Experimental Condition 30
Research participant receives the Core Components + Health Coaching
干预措施: Health Coaching (Behavioral)
Experimental Condition 32
Research participant receives the Core Components only
干预措施: Core Components (Behavioral)
Experimental Condition 1
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Health Coaching + Action Planning
干预措施: UV Real-Time Alerts (Behavioral)
Experimental Condition 1
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Health Coaching + Action Planning
干预措施: Action Planning (Behavioral)
Experimental Condition 4
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions
干预措施: Track Your Sun Protection (Behavioral)
Experimental Condition 8
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection
干预措施: Core Components (Behavioral)
Experimental Condition 9
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Health Coaching + Action Planning
干预措施: Current Conditions (Behavioral)
Experimental Condition 14
Research participant receives the Core Components + UV Real-Time Alerts + Health Coaching
干预措施: Health Coaching (Behavioral)
Experimental Condition 19
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Action Planning
干预措施: Track Your Sun Protection (Behavioral)
Experimental Condition 25
Research participant receives the Core Components + Current Conditions + Health Coaching + Action Planning
干预措施: Core Components (Behavioral)
Experimental Condition 1
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Health Coaching + Action Planning
干预措施: Track Your Sun Protection (Behavioral)
Experimental Condition 1
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Health Coaching + Action Planning
干预措施: Current Conditions (Behavioral)
Experimental Condition 1
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Health Coaching + Action Planning
干预措施: Health Coaching (Behavioral)
Experimental Condition 1
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Health Coaching + Action Planning
干预措施: Core Components (Behavioral)
Experimental Condition 2
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Health Coaching
干预措施: UV Real-Time Alerts (Behavioral)
Experimental Condition 3
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Action Planning
干预措施: Action Planning (Behavioral)
Experimental Condition 3
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions + Action Planning
干预措施: Core Components (Behavioral)
Experimental Condition 4
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions
干预措施: UV Real-Time Alerts (Behavioral)
Experimental Condition 4
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Current Conditions
干预措施: Current Conditions (Behavioral)
Experimental Condition 5
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Health Coaching + Action Planning
干预措施: Core Components (Behavioral)
Experimental Condition 7
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Action Planning
干预措施: UV Real-Time Alerts (Behavioral)
Experimental Condition 7
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection + Action Planning
干预措施: Core Components (Behavioral)
Experimental Condition 8
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection
干预措施: UV Real-Time Alerts (Behavioral)
Experimental Condition 8
Research participant receives the Core Components + UV Real-Time Alerts + Track Your Sun Protection
干预措施: Track Your Sun Protection (Behavioral)
Experimental Condition 9
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Health Coaching + Action Planning
干预措施: UV Real-Time Alerts (Behavioral)
Experimental Condition 9
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Health Coaching + Action Planning
干预措施: Health Coaching (Behavioral)
Experimental Condition 9
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Health Coaching + Action Planning
干预措施: Action Planning (Behavioral)
Experimental Condition 10
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Health Coaching
干预措施: UV Real-Time Alerts (Behavioral)
Experimental Condition 10
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Health Coaching
干预措施: Health Coaching (Behavioral)
Experimental Condition 11
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions + Action Planning
干预措施: Core Components (Behavioral)
Experimental Condition 12
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions
干预措施: UV Real-Time Alerts (Behavioral)
Experimental Condition 12
Research participant receives the Core Components + UV Real-Time Alerts + Current Conditions
干预措施: Core Components (Behavioral)
Experimental Condition 13
Research participant receives the Core Components + UV Real-Time Alerts + Health Coaching + Action Planning
干预措施: UV Real-Time Alerts (Behavioral)
Experimental Condition 13
Research participant receives the Core Components + UV Real-Time Alerts + Health Coaching + Action Planning
干预措施: Health Coaching (Behavioral)
Experimental Condition 13
Research participant receives the Core Components + UV Real-Time Alerts + Health Coaching + Action Planning
干预措施: Action Planning (Behavioral)
Experimental Condition 14
Research participant receives the Core Components + UV Real-Time Alerts + Health Coaching
干预措施: Core Components (Behavioral)
Experimental Condition 15
Research participant receives the Core Components + UV Real-Time Alerts + Action Planning
干预措施: UV Real-Time Alerts (Behavioral)
Experimental Condition 15
Research participant receives the Core Components + UV Real-Time Alerts + Action Planning
干预措施: Action Planning (Behavioral)
Experimental Condition 15
Research participant receives the Core Components + UV Real-Time Alerts + Action Planning
干预措施: Core Components (Behavioral)
Experimental Condition 16
Research participant receives the Core Components + UV Real-Time Alerts
干预措施: Core Components (Behavioral)
Experimental Condition 17
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Health Coaching + Action Planning
干预措施: Track Your Sun Protection (Behavioral)
Experimental Condition 17
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Health Coaching + Action Planning
干预措施: Current Conditions (Behavioral)
Experimental Condition 18
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Health Coaching
干预措施: Current Conditions (Behavioral)
Experimental Condition 18
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Health Coaching
干预措施: Health Coaching (Behavioral)
Experimental Condition 18
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Health Coaching
干预措施: Core Components (Behavioral)
Experimental Condition 19
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions + Action Planning
干预措施: Current Conditions (Behavioral)
Experimental Condition 20
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions
干预措施: Current Conditions (Behavioral)
Experimental Condition 20
Research participant receives the Core Components + Track Your Sun Protection + Current Conditions
干预措施: Core Components (Behavioral)
Experimental Condition 21
Research participant receives the Core Components + Track Your Sun Protection + Health Coaching + Action Planning
干预措施: Track Your Sun Protection (Behavioral)
Experimental Condition 21
Research participant receives the Core Components + Track Your Sun Protection + Health Coaching + Action Planning
干预措施: Health Coaching (Behavioral)
Experimental Condition 21
Research participant receives the Core Components + Track Your Sun Protection + Health Coaching + Action Planning
干预措施: Core Components (Behavioral)
Experimental Condition 22
Research participant receives the Core Components + Track Your Sun Protection + Health Coaching
干预措施: Track Your Sun Protection (Behavioral)
Experimental Condition 22
Research participant receives the Core Components + Track Your Sun Protection + Health Coaching
干预措施: Health Coaching (Behavioral)
Experimental Condition 22
Research participant receives the Core Components + Track Your Sun Protection + Health Coaching
干预措施: Core Components (Behavioral)
Experimental Condition 23
Research participant receives the Core Components + Track Your Sun Protection + Action Planning
干预措施: Track Your Sun Protection (Behavioral)
Experimental Condition 23
Research participant receives the Core Components + Track Your Sun Protection + Action Planning
干预措施: Core Components (Behavioral)
Experimental Condition 24
Research participant receives the Core Components + Track Your Sun Protection
干预措施: Core Components (Behavioral)
Experimental Condition 25
Research participant receives the Core Components + Current Conditions + Health Coaching + Action Planning
干预措施: Action Planning (Behavioral)
Experimental Condition 26
Research participant receives the Core Components + Current Conditions + Health Coaching
干预措施: Core Components (Behavioral)
Experimental Condition 27
Research participant receives the Core Components + Current Conditions + Action Planning
干预措施: Current Conditions (Behavioral)
Experimental Condition 27
Research participant receives the Core Components + Current Conditions + Action Planning
干预措施: Action Planning (Behavioral)
Experimental Condition 27
Research participant receives the Core Components + Current Conditions + Action Planning
干预措施: Core Components (Behavioral)
Experimental Condition 28
Research participant receives the Core Components + Current Conditions
干预措施: Current Conditions (Behavioral)
Experimental Condition 28
Research participant receives the Core Components + Current Conditions
干预措施: Core Components (Behavioral)
Experimental Condition 29
Research participant receives the Core Components + Health Coaching + Action Planning
干预措施: Core Components (Behavioral)
Experimental Condition 30
Research participant receives the Core Components + Health Coaching
干预措施: Core Components (Behavioral)
Experimental Condition 31
Research participant receives the Core Components + Action Planning
干预措施: Action Planning (Behavioral)
Experimental Condition 31
Research participant receives the Core Components + Action Planning
干预措施: Core Components (Behavioral)
结局指标
主要结局
Feasibility: Retention Rates
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Feasibility: Response Rates to Intervention Components(Intervention period (weeks 2-9))
- Sunburns(1-week bursts at baseline, post-intervention (2 months later), and 12 months post baseline.)
- Usability, Burden, and Acceptability Self-Reports(Post-assessment week 2 (2.5 months later))
研究者
Nabil Alshurafa
Principal Investigator
Northwestern University