Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions

Официальное название

SESAME: Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое Current Conditions
  This displays a participant's location's UVR index and notifies them of ultraviolet radiation forecasts for different times throughout the day.
• Поведенческое 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.
• Поведенческое 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.
• Поведенческое Core 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.

Первичные конечные точки

• Feasibility: Retention Rates [Срок оценки: Intervention period (weeks 2-9)]
• Feasibility: Completion of Daily Assessment Week Surveys [Срок оценки: 1-week bursts at baseline, post-intervention (2 months later) and 12 months post baseline.]
• Feasibility: Completion of Pre-Assessment Week Surveys [Срок оценки: 1-week bursts at baseline, post-intervention (2 months later) and 12 months post baseline.]
• Feasibility: Weekly Device Wear [Срок оценки: 1-week bursts at baseline, post-intervention (2 months later) and 12 months post baseline.]
• Unprotected Sun Exposure [Срок оценки: 1-week bursts at baseline, post-intervention (2 months later), and 12 months post baseline.]

Вторичные конечные точки (3)

• Feasibility: Response Rates to Intervention Components [Срок оценки: Intervention period (weeks 2-9)]
• Sunburns [Срок оценки: 1-week bursts at baseline, post-intervention (2 months later), and 12 months post baseline.]
• Usability, Burden, and Acceptability Self-Reports [Срок оценки: Post-assessment week 2 (2.5 months later)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 2 центра

• Northwestern University — Chicago
• Huntsman Cancer Institute at The University of Utah — Salt Lake City

Идентификаторы

NCT: NCT07556380 · IRB_00174538 · 1R34CA283480-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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