Creation of an Infrastructure to Support Delivery of mHealth Interventions for Cancer Patients Throughout Florida
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 3
- 主要终点
- Feasibility: Screening
研究概览
简要总结
Despite the deleterious impact of smoking upon cancer treatment outcomes, smoking prevalence remains alarmingly high among cancer patients. Thus, reducing smoking by cancer patients is a public health priority, but treatments to date have demonstrated limited efficacy. Mobile health (mHealth) interventions have the potential to improve treatment efficacy while also greatly extending reach. The goal of this infrastructure proposal is to build a resource to facilitate the creation of mHealth tools that address the tobacco treatment needs of cancer patients. This resource, which will be available to researchers throughout Florida, would fill a critical gap in mHealth capacity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •≥18 years of age.
- •≥100 lifetime cigarettes.
- •English-speaking.
- •Report smoking ≥ 1 cigarette in past 30 days.
- •Working smartphone.
排除标准
- •Failure to electronically confirm participation within 14 days of randomization via electronic link sent to participant's smartphone.
- •Currently pregnant or breastfeeding.
研究组 & 干预措施
Demonstration Project 2
Pilot RCT of Quitline vs. Mobile-Delivered Smoking Cessation Intervention for Cancer Patients. The goal of this pilot feasibility study is two-fold: to evaluate the performance of the platform itself and to provide preliminary data for a future efficacy trial.
干预措施: Quitline Treatment (QT) (Other)
Demonstration Project 1
Screening and recruitment of cancer patients for connection to evidence-based smoking cessation treatment. The goal of the first demonstration project is to develop a feasible and effective method for screening cancer patients for smoking, determining treatment eligibility, and offering treatment.
Demonstration Project 2
Pilot RCT of Quitline vs. Mobile-Delivered Smoking Cessation Intervention for Cancer Patients. The goal of this pilot feasibility study is two-fold: to evaluate the performance of the platform itself and to provide preliminary data for a future efficacy trial.
干预措施: App-based Treatment (mHealth) (Other)
Demonstration Project 3
Utilizing machine learning to process data obtained from demonstration projects 1 and 2. In Demonstration Project 3, we will utilize all data collected in Demonstration Projects 1 and 2 to conduct machine and deep learning methods.
结局指标
主要结局
Feasibility: Screening
时间窗: At Baseline
Our screening process will be deemed feasible if: 1) ≥ 90% of patients complete the screener, 2) the proportion of patients identified as smokers meets or exceeds the historical self-reported proportions at each institution, 3) the program correctly identifies eligible participants and subsequently presents automated advice to quit, 4) it offers an opportunity to enroll in smoking cessation treatment, and 5) ≥ 30% of eligible patients enroll in treatment.
Usability: mHealth
时间窗: Up to 6 Months
Usability will be measured 2 ways: I) ≥ 80% will score ≥ 70 on the Systems Usability Scale (SUS), 10-item measure, (scores 0-100) assessing learnability and usability. II) ≥ 80% rate app as easy to use (dichotomous Y/N).
Acceptability/Satisfaction: mHealth
时间窗: Up to 6 Months
Acceptability/Satisfaction will be measured 4 ways: I) ≥ 80 will score mean ≥ 3.0 Client Satisfaction Questionnaire (CSQ), 8-item measure, (1-4 scale). II) ≥ 80% mostly or extremely satisfied with app. III) ≥ 80% would recommend this app to a friend to quit smoking (dichotomous Y/N). IV) ≥ 80% rate quality of intervention as good or excellent.
次要结局
未报告次要终点