Cancer Distress Coach Mobile App Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 569
- 试验地点
- 2
- 主要终点
- Change in PTSD symptoms as measured by the PTSD Checklist (PCL-5)
研究概览
简要总结
The Cancer Distress Coach (CDC) mobile app is a symptom management tool for posttraumatic stress disorder (PTSD) in cancer patients and caregivers. Based largely on "PTSD Coach" from the National Center for PTSD, the CDC app was redesigned for both iOS and Android platforms and is tailored specifically to individuals impacted by cancer.
This study aims to evaluate whether CDC app usage influences symptoms of PTSD through a randomized controlled trial (RCT) where subjects are placed into either the intervention group or the wait-listed control group for a period of 8 weeks. The CDC app is available as a free download on the App Store® and on Google Play™.
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
- •Have been diagnosed with cancer or are/were a caregiver to someone with cancer
- •Resident of the United States of America
- •Able to read and write English
- •Age ≥ 18 years
排除标准
- 未提供
结局指标
主要结局
Change in PTSD symptoms as measured by the PTSD Checklist (PCL-5)
时间窗: Baseline, Week 4, Week 8
The PCL-5 is a 20-item self-report symptom checklist that closely mirrors DSM-5 diagnoses criteria. The instructions will be modified so that symptoms are keyed to the particular traumatic stressor of interest; specifically, subjects will be asked to rate each PTSD symptom in the past 4 weeks with respect to their cancer diagnosis and treatment.
次要结局
- Change in stress management self-efficacy as measured by the Self-efficacy questionnaire(Baseline, Week 4, Week 8)
- Change in distress level as measured by the Distress Thermometer(Baseline, Week 4, Week 8)