跳至主要内容
临床试验/NCT03597737
NCT03597737已完成不适用

Utility of an APP for the Monitoring of Irruptive Oncological Pain

Universitat Jaume I2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2018年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
2
主要终点
Change in side effects of pain medication

研究概览

简要总结

The present investigation aims at exploring the effect of including a pain app called Pain Monitor irruptive oncological pain for chronic pain patients' daily monitoring. Two conditions will be set:

  1. usual treatment (waiting list)
  2. usual treatment + APP

详细描述

Irruptive oncological pain (IOP) is defined as an exacerbation of pain in cancer patients whose base pain is stable (e.g., less than 4 on a scale of 0 to 10 for more than 12 hours a day) and is well controlled with opioids. This pain increase can appear both spontaneously and associated to a specific determining factor, be it predictable or unpredictable. The IOP tends to appear quickly (3-5 minutes) and usually have a short duration (average 30 minutes, although pain may last more than 60 minutes) and moderate intensity to elevated . The median episodes of breakthrough pain per day is of 3.

The prevalence of IOP is alarmingly high. A review study of 19 works scientists places the number of cancer patients with IOP in approximately 60%. In addition, the IOP is associated with a significant decrease in the quality of life of the patients. For example, a study conducted in different countries in Europe with 1000 cancer patients revealed that in more than 80% of the participants, the appearance of breakthrough pain completely interrupted their activities. Only 11% of the patients interviewed expressed that the IOP did not interfere in their activities. For the rest of the patients, the most affected areas were sleep and emotional well-being. In addition to these costs in the quality of life of patients with IOP, recent studies have warned of the consequences of this type of pain. Thus, an investigation carried out in the United States evidenced that three quarters of the patients interviewed had experienced important economic losses as a result of the pain, being the average direct costs associated with the IOP of $ 891 per person per month.

Aiming to choose the most appropriate study methodology for this type of pain (often unpredictable and of short duration), the investigators have reviewed the works carried out up to the moment on characteristics and treatment of the IOP. Descriptive studies on IOP tend to use a most retrospective observational methodology, which can lead to biases and inaccuracies. For example, in the most ambitious study carried out so far, 1000 patients with IOP were urged to remember the characteristics of pain episodes, such as the average intensity, the approximate average duration and the average number of events per day.

Regarding the investigations on the effectiveness of the treatment of the IOP, the studies comparing different drugs tend to perform clinical trials, while to study the response to a particular drug, seems more adequate continuous assessment of each patient during an IOP episode. This last methodology with repeated measures seems the most adequate in IOP, since the use of clinical trials with few measures (baseline, post-treatment and follow-up) has the limitation of not allowing daily monitoring of patient's pain episodes.

Although daily assessments seems to be the most suitable design for the monitoring of patients with IOP, the implementation of this type of methodology could be very expensive because requires continuous evaluation. To facilitate this, several studies have already shown that mobile applications (APP) can effectively monitor the evolution of a wide range of pathologies in the context of health. In fact, a controlled clinical study recently made found that the records eco-friendly through mobile APPs were more reliable than registers with pencil and paper.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

盲法说明

Patients will be informed of the condition they have been assigned to.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patient is over 18 years of age
  • Irruptive oncological pain
  • The patient has a mobile phone with Android operating system
  • The patient has the physical ability to use the application
  • The patient does not present psychological and / or cognitive alterations or problems with language that make their participation difficult- The patient voluntarily wants to participate and signs the informed consent

排除标准

  • The patient is under 18 years
  • The patient does not have a mobile phone or has a mobile phone in which Android is not the operating system (the app is currently only available for Android for economic reasons)
  • The patient does not have the physical capacity to use the application
  • The patient does not have the capacity to participate due to psychological and / or cognitive alterations or problems with language
  • The patient does not want to participate

结局指标

主要结局

Change in side effects of pain medication

时间窗: Twice (first day of study and 30 days after, at the end of study)

A list of the most frequent side effects of pain medication has been created. Responses are dichotomous (0=did not experience the side effect; 1=experienced the side effect)

Change in average pain intensity in the past week assessed by a Numerical Rating Scale in the Brief Pain Inventory-Short Form

时间窗: Twice (first day of study and 30 days after, at the end of study)

The Brief Pain Inventory-Short Form (BPI-SF) will be used to measure average pain intensity. The item has a response range from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores represent higher pain intensity levels

次要结局

  • Change in the amount of rescue medication used in the past week(Twice (first day of study and 30 days after, at the end of study))
  • Change in physical health status measured with the Physical Composite Score in the SF12(Twice (first day of study and 30 days after, at the end of study))
  • Change in mental health status measured with the Mental Composite Score in the SF12(Twice (first day of study and 30 days after, at the end of study))
  • Change in anxiety measured by the Tension scale in the POMS(Twice (first day of study and 30 days after, at the end of study))
  • Change in average interference of pain in functioning in the past week measured by a Numerical Rating Scale in the Brief Pain Inventory-Short Form(Twice (first day of study and 30 days after, at the end of study))
  • Change in depression measured by the Sadness scale in the POMS(Twice (first day of study and 30 days after, at the end of study))
  • Change in neuropathic symptoms(Twice (first day of study and 30 days after, at the end of study))

研究者

发起方
Universitat Jaume I
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验