Effectiveness of a Mindfulness Smartphone App ("Staying Calm in the OR") to Reduce Distress in People With Cancer Waiting for Surgery: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 102
- Locations
- 2
- Primary Endpoint
- Change in anxiety and depression
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Principal investigator randomize the participants. Two psychologists who do not know the allocation perform the assessments, mostly through self-reported instruments. Another investigator analyze the outcomes.
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 - 100 years old
- •Diagnosis of cancer
- •Being in waitlist for surgery for less than 14 days
- •Signed informed consent
Exclusion Criteria
- •Acute severe mental disorder according to DSM-5 diagnostic criteria
- •Not having a smartphone
- •Not being able to download and use the smartphone app "Calm before Surgery"
Arms & Interventions
App "Staying Calm in the OR"
"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) or Mindfulness Self Compassion (MSC).
Intervention: Staying Calm in the OR (Behavioral)
Treatment as Usual (TAU)
Participants assigned to Treatment As Usual (TAU) arm will not download the app until the study is completed.
Outcomes
Primary Outcomes
Change in anxiety and depression
Time Frame: From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery)
Change in Hospital Anxiety and Depression Scale (HADS). Anxiety and depressive symptoms are measured with this self-reported instrument. The scores of the 15 items range from 0 to 4. The final score is the summatory of these items and range from 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Secondary Outcomes
- Change in oxygen saturation(From surgery to hospital discharge (around 7 days after surgery))
- Change in pain experience(From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery))
- Change in temperature(From surgery to hospital discharge (around 7 days after surgery))
- Change in quality of life(From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery))
- Change in analgesia(From surgery to hospital discharge (around 7 days after surgery))
- Presence of post-surgery complications(Clavien-Dindo Scale score at hospital discharge (around 7 days after surgery))
- Change in blood pressure(From surgery to hospital discharge (around 7 days after surgery))