Blood Cancer Symptom Management App Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Change in Edmonton Symptom Assessment Scale (ESAS)
研究概览
简要总结
The purpose of this study is to test the effectiveness of evidence-informed mobile apps, Myeloma Coach and CLL Coach. These apps have been developed to help manage the physical and emotional symptoms experienced by multiple myeloma and chronic lymphocytic leukemia survivors. This study hopes to determine if a mobile app is a useful tool to help people manage commonly reported symptoms related to Multiple Myeloma (MM) and chronic lymphocytic leukemia (CLL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Be at least 18 years of age;
- •Be a resident of the United States of America;
- •Be able to read and write English
- •Consistent access to the internet via a smartphone, tablet or computer
- •Have a diagnosis of multiple myeloma or chronic lymphocytic leukemia
排除标准
- 未提供
结局指标
主要结局
Change in Edmonton Symptom Assessment Scale (ESAS)
时间窗: Baseline, 4 weeks, 8 weeks
The ESAS is a validated 10 item survey index used to assessed symptoms. The total ranges from 0 to 60, with a higher score indicating higher physical symptom burden.
Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Short Form Global Health
时间窗: Baseline, 4 weeks, 8 weeks
This validated 10 item survey captures a person's self assessment of their global physical and global mental health. The possible score ranges from 0 to 20 points in each case. 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health.
Change in NCCN Distress Thermometer
时间窗: Baseline, 4 weeks, 8 weeks
The NCCN Distress Thermometer (DT) is a one-item, 11-point Likert scale represented on a visual graphic of a thermometer that ranges from 0 (no distress) to 10 (extreme distress), with which patients indicate their level of distress over the course of the week prior to assessment.
Change in severity of PTSD related symptoms as measured by PTSD Checklist (PCL5)
时间窗: Baseline, 4 weeks, 8 weeks
This validated 20 item measure has been used extensively in research. Scores consist of a total symptom severity score (from 0 to 80) from four subscales: Re-experiencing (items 1-5 - max score = 20), Avoidance (items 6-7 - max score = 8), Negative alterations in cognition and mood (items 8-14 - max score = 28), and Hyper-arousal (items 15-20 - max score = 24). Higher scores represent higher severity.
次要结局
未报告次要终点