Pilot Test of an mHealth Intervention for Reducing Alcohol Use Among Adolescent and Young Adult Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percent of Eligible Participants Enrolling in the Study
研究概览
简要总结
The objective of this study is to adapt and test the feasibility of a 4-week motivational interviewing mHealth intervention, Tracking and Reducing Alcohol Consumption (TRAC), to reduce alcohol use among adolescent and young adult (AYA) cancer survivors during post-treatment survivorship.
At the end of this study, the feasibility data gathered will inform a definitive randomized controlled trial of TRAC-AYA to test the efficacy of the adapted intervention.
详细描述
For this study, the investigators will adapt and pilot an existing mHealth intervention (TRAC) to reduce alcohol use among AYAs as part of a randomized controlled trial. TRAC includes weekly phone sessions with an interventionist and incorporates smartphones for daily self-monitoring of alcohol use. Upon enrollment, participants will be randomized into either the intervention (TRAC) arm or control (education and daily self-monitoring) arm.
Researchers will conduct the study in Kentucky, which leads the nation in cancer incidence and mortality, has a higher incidence of AYA cancers compared to other states, is 40% rural, and encompasses over 100 medically underserved areas. Participants will be recruited from the University of Kentucky Markey Cancer Center and its affiliate institutions.
Preliminary data used for this study were collected from a study (PI: Lauckner, K01AA02530) testing the TRAC intervention with people living with HIV/AIDS, which has shown promising preliminary results, with high feasibility, acceptability, and encouraging preliminary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with cancer between age 15-39
- •Currently age 18-39
- •3 months-15 years post-treatment
- •Meets criteria for risky alcohol use
- •Reside in United States
排除标准
- •Severe psychopathology
研究组 & 干预措施
Control
Participants in the control group will receive educational materials regarding alcohol consumption and its link to cancer . They will also participate in smartphone monitoring of alcohol use on the same schedule as participants in the intervention group. This will allow us to compare daily alcohol use data between the two conditions and evaluate the added component of weekly counseling in TRAC.
干预措施: No intervention (Other)
TRAC: Tracking and Reducing Alcohol Consumption
The TRAC intervention focuses on increasing motivation and building skills to reduce alcohol use and involves 4, 30-minute sessions with an interventionist done via video chat or phone.
Participants will complete smartphone-based self-monitoring of alcohol use. Each morning, participants complete a mobile survey indicating if they drank the previous day and if so, how many drinks they had. Surveys will be programmed using REDcap and sent via a link in the reminder text message. Additionally, participants will be prompted each evening and asked to complete a breathalyzer reading using a mobile app to determine blood alcohol content (BAC). If safety concerns are identified (e.g., BAC ≥0.30; blackouts), the interventionist will refer the AYA to a licensed provider with expertise in substance use treatment.
干预措施: TRAC: Tracking and Reducing Alcohol Consumption (Behavioral)
结局指标
主要结局
Percent of Eligible Participants Enrolling in the Study
时间窗: 17 months
The primary feasibility outcome is enrollment, with a goal of 60% of eligible AYAs approached enrolling in the study. A higher percentage of individuals who enroll in the study indicate the intervention is accessible to the target population.
Percent of Eligible Participants Enrolling in the Study
时间窗: 17 months
The primary feasibility outcome is enrollment, with a goal of 60% of eligible AYAs approached enrolling in the study. A higher percentage of individuals who enroll in the study indicate the intervention is accessible to the target population.
次要结局
- Average Percent of Daily Monitoring Tasks Completed(6 weeks)
- Percent of Participants Completing Follow-up(10 weeks)
- Percent of Participants Completing Majority of Intervention Sessions(6 weeks)
- Percent of Participants Completing Follow-up(10 weeks)
- Percent of Participants Completing Majority of Intervention Sessions(6 weeks)
- Average Percent of Daily Monitoring Tasks Completed(6 weeks)
研究者
Carolyn Lauckner
Associate Professor
University of Kentucky