Utility of an APP for the Monitoring of Irruptive Oncological Pain
Utility of an APP for the Monitoring of Irruptive Oncological Pain
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
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.

 As for the existing APPs in pain, an exhaustive review of the available APPs revealed that
 there was little evidence to support the use of these technologies. Specifically, these
 authors showed that the most APPs did not specify whether their content was validated, APPs
 did not include psychological components and none had been applied in a clinical study. In
 the light of these results, the investigators contacted the Labpsitec research team of the
 University Jaume I, who have developed and validated a pain application called "Pain
 Monitor".

 The APP daily evaluates the variables recommended by the Initiative on Methods, Measurement
 and Evaluation of Pain (IMMPACT): intensity of the pain, use of rescue analgesics, pain
 interference in functioning, state of mood, general perception of health and evaluation of
 treatment effectiveness. In addition, "Pain Monitor" also assesses psychological factors and
 behavior that influence the experience of pain: catastrophism, acceptance, fear / avoidance
 and coping. The APP seems especially indicated for IOP monitoring since, following the
 recommendations of the guide "Comprehensive approach to the patient with irruptive
 oncological pain", allows patients access at any time to record the characteristics of pain
 (place, intensity, duration and characteristics of pain) and frequency of use of medication
 for the spikes of pain. Finally, the APP allows to create alarms so that, undesirable
 clinical events (e.g., severe or recurrent adverse effect, increased pain basal, no pain
 reduction after use of rescue medication, low adherence to treatment), are sent by email to
 the principal investigator of the study.

 Thus, the study objective is to test if the introduction of the Pain Monitor APP in the
 day-to-day work of the pain unit improves pain management of irruptive oncological pain
 patients. To do this, it is necessary to compare the evolution of patients who follow the
 usual treatment at the pain unit (without app) with a group of patients who do use the Pain
 Monitor APP.

 The investigators will perform a clinical trial comparing the 2 conditions mentioned above:

 1. usual treatment (waiting list)

 2. usual treatment + APP

 Therefore, this is a clinical trial without drugs. This is not an observational study since
 the physicians of patients in the app + alarms condition will be asked to react to an alarm
 (i.e., if the patient has nausea for 3 consecutive days) by calling the patient and changing
 the treatment telematically, if necessary, so that the patient can collect the prescription
 at his primary care center. If the condition APP results in a better treatment of irruptive
 oncological pain patients, participants of the waiting list will be offered the possibility
 to use the app at the end of the study.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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