Utility of an APP for the Monitoring of Irruptive Oncological Pain
Condition: Oncology; Pain, Acute; Pain, Chronic
MeSH terms: Acute Pain; Chronic Pain; Cancer Pain
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): Pain APP
Intervention type(s): Device
Intervention description(s): pain app Pain Monitor app has been developed by a multidisciplinary pain expert panel, including physicians, psychologists, and nurses. Content has been validated in a previous study and usability has been shown to be excellent.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: One condition
Masking: None (Open Label)
Primary purpose: Device Feasibility