Effectiveness of a Mindfulness Smartphone App to Reduce Emotional Distress in People With Cancer Waiting for Surgery
Condition: Cancer
Study type: Interventional

Summary: 
      Lung cancer and colorectal cancer accounted for the highest number of cancer deceases in
      2016. Incidence is around 3.500 cases per year and patients are more commonly men (56%) aged
      around 69. This study focuses on people with a recent diagnosis of cancer who have been
      scheduled for surgery.

      Evidence suggests that around 11% of people with cancer suffer from anxiety or adjustment
      disorders and 6,5% hold a diagnosis of major depressive disorder. Moreover, the perioperative
      period is the most distressing phase of the illness. However, a high number of patients do
      not have access to mental health services due to either limited resources and geographical
      limitations or the fear of being stigmatized. The aim is to explore the effectiveness of a
      mindfulness-based intervention for smartphones designed to reduce pre-surgical distress. It
      was conceived as a medical tool of prevention), with the purpose of diminishing emotional
      suffering and clinical complications after surgery. In 2020 Internet will be the most
      developed technology and almost everyone will have a smartphone; hence, an app for stress
      reduction will fit in this growing field.

      Mindfulness is defined as the ability to pay attention to the present moment with a curious,
      non-judgmental attitude. Its training consists of both formal meditation practices and
      informal daily exercises. Mindfulness-based interventions are growing in our National Health
      System and rigorous researches are being conducted exhibiting good results regarding its
      effectiveness. However, the fact that Mindfulness instructors must be highly qualified makes
      these kinds of interventions exceedingly costly to implement. This team is experienced with
      mindfulness and has developed the app "En Calma en el Quirófano" ("Staying Calm in the OR")
      to reduce distress before surgery. It consists of a free, accessible, on-demand, short
      training through a series of guided meditation practices.

      In this randomized controlled trial, participants are assigned either to the experimental
      ("Staying Calm in the OR") or the control arm (treatment as usual). The investigators expect
      anxiety and depression to be lower in the experimental arm; in addition, the researchers
      expect that "Staying Calm in the OR" participants will show higher levels of post-surgery
      recovery.
    

Detailed description: 
      Lung cancer and colorectal cancer accounted for the highest number of cancer deceases in
      2016. Incidence is around 3.500 cases per year and patients are more commonly men (56%) aged
      around 69. This study focuses on people with a recent diagnosis of cancer who have been
      scheduled for surgery.

      Evidence suggests that around 11% of people with cancer suffer from anxiety or adjustment
      disorders and 6,5% hold a diagnosis of major depressive disorder. Moreover, the perioperative
      period is the most distressing phase of the illness. However, a high number of patients do
      not have access to mental health services due to either limited resources and geographical
      limitations or the fear of being stigmatized. The aim is to explore the effectiveness of a
      mindfulness-based intervention for smartphones designed to reduce pre-surgical distress. It
      was conceived as a medical tool of prevention), with the purpose of diminishing emotional
      suffering and clinical complications after surgery. In 2020 Internet will be the most
      developed technology and almost everyone will have a smartphone; hence, an app for stress
      reduction will fit in this growing field.

      Mindfulness is defined as the ability to pay attention to the present moment with a curious,
      non-judgmental attitude. Its training consists of both formal meditation practices and
      informal daily exercises. Mindfulness-based interventions are growing in our National Health
      System and rigorous researches are being conducted exhibiting good results regarding its
      effectiveness. However, the fact that Mindfulness instructors must be highly qualified makes
      these kinds of interventions exceedingly costly to implement. This team is experienced with
      mindfulness and has developed the app "En Calma en el Quirófano" ("Staying Calm in the OR")
      to reduce distress before surgery. It consists of a free, accessible, on-demand, short
      training through a series of guided meditation practices.

      In this randomized controlled trial, participants are assigned either to the experimental
      ("Staying Calm in the OR") or the control arm (treatment as usual). The investigators expect
      anxiety and depression to be lower in the experimental arm; in addition, the researchers
      expect that EnCalma participants will show higher levels of post-surgery recovery.

      Main hypothesis. Anxiety and depression symptoms will be significantly lower in the
      experimental arm after Staying Calm in the OR" training.

      Secondary hypotheses. Recovery after surgery will be higher amongst participants in the
      experimental arm, who will exhibit fewer post-surgical complications, lower rates of
      hospitalizations, lower levels of analgesia, shorter hospitalizations and a better quality of
      life.
    

Intervention name(s): Staying Calm in the OR
Intervention type(s): Behavioral
Intervention description(s): "Staying Calm in the OR" is a mindfulness-based stress-reduction smartphone tailored for people who are waiting for surgery. It consists of a free, accessible, on-demand, short training through a series of guided meditation practices. They are based on widely studied mindfulness-based programs, such as Mindfulness-Based Stress Reduction (MBSR) ir Mindfulness Self Compassion (MSC).
Other intervention name(s): En Calma en el Quirófano; EnCalma
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomly allocated to the intervention arm (app) or to the control arm (treatment as usual [TAU])
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: cancer; mindfulness; RCT; e-Health; En Calma en el Quirófano; Staying Calm in the OR