The Pain Squad+ Smartphone App To Support Real-Time Pain Management for Adolescents With Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 18
- 主要终点
- Brief Pain Inventory (BPI)
研究概览
简要总结
Pain negatively affects the quality of life of adolescents with cancer (AWC). It can also represent a high cost to the healthcare system and families. In response, our team has built a smartphone-based app, called Pain Squad+, which can give AWC real-time advice to manage their pain. The app uses pain diaries and personalized pain advice plus support from a registered nurse to give real-time pain management in all settings. This study will look at the impact of Pain Squad+, with or without the nurse support, on AWC health quality and healthcare costs over time.
详细描述
Pain negatively affects the quality of life (QOL) of adolescents with cancer (AWC), slows cancer recovery, and results in negative long-term health effects. Pain is also significant cost to the healthcare system and families. To address this problem, the study investigators have developed and used a phased-approach to test a smartphone-based app, called Pain Squad+. Using this app AWC report the pain they have and the app provides AWC with advice on how to treat this pain based on an algorithm our team developed. An email is also sent to a nurse if an AWC reports severe pain 3 times in a row. The nurse then contacts the AWC to assist in treating pain. This project will test the effect of the Pain Squad+ app, with and without nurse help, on treating pain and other pain-related health issues and managing costs associated with pain care, when compared to AWC not using the app. Investigators will enroll 222 AWC recruited from 9 Canadian pediatric oncology care centres into a 3-group randomized controlled trial. AWC in the experimental groups will be asked to use Pain Squad+ for 8 weeks (with or without nurse involvement) and all groups will complete pain-related outcome measures at baseline, 2-, 4-, 8-, and 16-weeks. The primary study outcome will be pain intensity. The secondary study outcomes will be (a) pain interference; (b) QOL; (c) pain self-efficacy; and (d) cost effectiveness and utility. Investigators will use established statistical methods to analyze the health and cost data collected over the course of this study. A real-time and cost effective way to address the problem of pain in AWC is needed. Pain Squad+ can improve pain treatment and QOL for AWC as well as decrease costs incurred by families and the healthcare system. If effective, the Pain Squad+ as a model of technology-assisted care may represent a way to improve the QOL for a range of Canadian patients by treating a variety of physical and psychological symptoms the moment they occur.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 12-18 years,
- •are able to speak and read English,
- •are diagnosed with cancer (all disease types),
- •are on active therapy,
- •have an average self-reported pain score of ≥3/10 measured using an 11-point numerical rating scale (NRS) over the preceding week, and
- •have an English-speaking and reading caregiver who is willing and able to complete outcome measures related to healthcare encounters
排除标准
- •with significant cognitive impairments or co-morbid illnesses (as determined by their medical team) that would limit interaction with Pain Squad+ or outcome measure assessment,
- •who are currently participating in other pain management studies, and
- •who are not expected to survive past 16 weeks as determined by their oncologist
结局指标
主要结局
Brief Pain Inventory (BPI)
时间窗: Change from baseline Brief Pain Inventory measure at 4 time points: 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline
The BPI assesses current pain and 'worst', 'least', and 'average' pain in the preceding week using an 11-point numerical rating scale (NRS) with verbal anchors 'no pain' at 0 and 'pain as bad as you can imagine' at 10. Item scores are averaged to give a Pain Intensity Summary Score.
次要结局
- Pediatric Quality of Life Inventory (PedsQL) 4.0(Baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline)
- Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference Short-form Scale(Baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline)
- Health Utility Index Mark 2/3 (HUI2/3)(Baseline, 8 weeks after baseline, 16 weeks after baseline)
- Porter's scale(Baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 16 weeks after baseline)
- Health Services Use(Baseline, 8 weeks after baseline, 16 weeks after baseline)
研究者
Jennifer Stinson
Senior Scientist
The Hospital for Sick Children