Evaluating a Mobile Application to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 313
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire-8
研究概览
简要总结
The overarching goals of this project are to provide the first rigorous test of a scalable and publicly accessible mobile health intervention (IntelliCare) to address emotional distress in women with breast cancer, and to test the impact of human coaching as a way to increase engagement with digital health interventions to improve outcomes. To achieve these goals, an innovative experimental study design, known as a Sequential, Multiple Assignment, Randomized Trial (SMART), will be used to test the effects of the IntelliCare apps on symptoms of depression and anxiety, as well as the added value of human support to improve participant engagement. 313 breast cancer survivors diagnosed within the past 5 years and who screen positive for elevated symptoms of depression and/or anxiety will be recruited. Participants will initially be randomized to receive the IntelliCare apps or app-delivered patient education (control) for 8 weeks, and the impact of the IntelliCare apps on reducing symptoms of depression and anxiety in breast cancer survivors relative to control will be tested (Aim 1). We will monitor the app usage data of participants who receive the IntelliCare apps. Those who are high-engagers will continue to use the apps with no change. Those who are low-to-moderate engagers will be rerandomized after 1 week to either receive added coaching vs. not (i.e., no change) in addition to the apps. The hypothesis is that added coaching to address barriers to app usage will lead to greater engagement with the apps (Aim 2), for low-to-moderate engagers. Finally, semi-structured exit interviews will be conducted with participants that receive the IntelliCare apps and coaching. Interviews will capture survivors' perceptions about the extent to which, and how, tailoring the apps and coaching specifically for breast cancer survivors may improve intervention outcomes and engagement (Aim 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years (age 19 if in Nebraska, given age of consent);
- •0-5 years post-diagnosis of Stage I, II, or III female breast cancer;
- •elevated symptoms of depression as measured by the Patient Health Questionnaire-8 (PHQ-8) score ≥ 10 and/or symptoms of anxiety as measured by the Generalized Anxiety Disorder-7 (GAD-7) score ≥ 8.
排除标准
- •Taking antidepressant medication and have had an appointment to adjust the dosage over the past 2 weeks;
- •mental health condition deemed to interfere with study procedures or put the participant at undue risk based on self-reported history of psychosis or bipolar disorder, or active suicidal ideation that necessitates more intense care;
- •do not have an app-compatible phone (i.e., iOS 10.3 or later or Android 4.0.3 or later);
- •cannot read and speak English (current intervention only available in English).
结局指标
主要结局
Patient Health Questionnaire-8
时间窗: 12 month follow up
8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.
Generalized Anxiety Disorder-7
时间窗: 12 month follow up
7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.
次要结局
- Multidimensional Fatigue Symptom Inventory-Short Form(12 months)
- Pittsburgh Sleep Quality Index(12 months)
- Alcohol Use Disorders Identification Test(12 months)
- PROMIS Satisfaction With Sex Life(12 months)
- UAMS Health Literacy Measure(12 months)
- Penn State Worry Questionnaire(12 months)
- App Engagement From App Sessions(Frequency of unique app sessions from Baseline through 8 weeks)
- TWente Engagement With Ehealth Technologies Scale (TWEETS)(12 months)
- App Engagement From App Sessions(Frequency of unique app sessions from Baseline through 8 weeks)
- App Engagement From App Session Duration(Duration in seconds of app sessions from Baseline through 8 weeks)
- App Engagement From App Downloads(Number of apps downloaded from Baseline through 8 weeks)
- 36-Item Short Form Survey - Physical Health(12 months)
- 36-Item Short Form Survey - Mental Health(12 months)
- Multidimensional Fatigue Symptom Inventory-Short Form(12 months)
- Pittsburgh Sleep Quality Index(12 months)
- Alcohol Use Disorders Identification Test(12 months)
- PROMIS Global Mental Health v1.2(12 months)
- PROMIS Satisfaction With Sex Life(12 months)
- UAMS Health Literacy Measure(12 months)
- Penn State Worry Questionnaire(12 months)
- Ten Item Personality Inventory- Extraversion(Baseline)
- Ten Item Personality Inventory - Extraversion(12 months)
- Ten Item Personality Inventory - Agreeableness(12 months)
- Ten Item Personality Inventory - Conscientiousness(12 months)
- Ten Item Personality Inventory - Neuroticism(12 months)
- Ten Item Personality Inventory - Openness(12 months)
- TWente Engagement With Ehealth Technologies Scale (TWEETS)(12 months)
研究者
Philip Chow, Ph.D.
Assistant Professor
University of Virginia