CancerNCT04184557
Effectiveness of a Mindfulness Smartphone App to Reduce Emotional Distress in People With Cancer Waiting for Surgery
A study testing Staying Calm in the OR in people with Cancer, run by Instituto de Investigación Hospital Universitario La Paz at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cancer
- What is being tested?
- Staying Calm in the OR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Feb 2019to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 100 years old
- Diagnosis of cancer
- Being in waitlist for surgery for less than 14 days
- Signed informed consent
Who cannot join
- 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"
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
12 Octubre University Hospital
Madrid, 28041
La Paz University Hospital
Madrid, 28045
About this study
Official title: 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
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.
Read more
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Staying Calm in the OR
- Keywords
- cancer, mindfulness, RCT, e-Health, En Calma en el Quirófano, Staying Calm in the OR
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staying Calm in the ORBehavioural
Also called En Calma en el Quirófano, EnCalma
"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).
| Study group | Role | What they receive |
|---|---|---|
| App "Staying Calm in the OR" | Experimental | "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). Receives: Behavioral: Staying Calm in the OR |
| Treatment as Usual (TAU) | No intervention | Participants assigned to Treatment As Usual (TAU) arm will not download the app until the study is completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety and depression
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.
Measured: From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery)
Secondary outcomes (7)
Change in quality of life
Change in World Health Organization Quality of Life Brief Scale (WHOQOL-BREF). This is a self-reported instrument that how much the person is satisfied with many aspects of his or her live, and general domains of the quality of life construct. There are 26 items and each one is scored from 0 to 5. Higher scores suggest better quality of life in direct items and poorer quality of life in reverse items. The final score range from 0 to 130, and the higher the score the better the perceived quality of life.
Measured: From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery)
Change in pain experience
Change in Visual Analog Scale (VAS) for pain. In this visual scale, the evaluator needs to rate how much pain is he or she experiencing in the present moment. Scores range from 0 (no pain at all) to 10 (extreme pain).
Measured: From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery)
Presence of post-surgery complications
Clavien-Dindo Scale score. This scale measures complications in surgery. They evaluator has to choose among the following categories:
Grade I. Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. This grade also includes wound infections opened at the bedside.
Grade II. Requiring pharmacological treatment with drugs other than such allowed for grade I complications.
Blood transfusions and total parenteral nutrition also included.
Grade III. Requiring surgical, endoscopic or radiological intervention
- IIIa. Intervention not under general anesthesia
- IIIb. Intervention under general anesthesia
Grade IV. Life-threatening complication (including CNS complications) requiring IC/ICU-management
- IVa. Single organ dysfunction (including dialysis)
- IVb. Multiple organ dysfunction
Grade V Death of a patient
Measured: Clavien-Dindo Scale score at hospital discharge (around 7 days after surgery)
Change in blood pressure
Change in blood pressure, as registered by nursers during the hospitalization period
Measured: From surgery to hospital discharge (around 7 days after surgery)
Change in oxygen saturation
Change in oxygen saturation, as registered by nursers during the hospitalization period
Measured: From surgery to hospital discharge (around 7 days after surgery)
Change in temperature
Change in temperature, as registered by nursers during the hospitalization period
Measured: From surgery to hospital discharge (around 7 days after surgery)
Change in analgesia
Change in analgesia, as registered by nursers during the hospitalization period
Measured: From surgery to hospital discharge (around 7 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start15 Feb 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly allocated to the intervention arm (app) or to the control arm (treatment as usual \[TAU\])
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beatriz Rodríguez-Vega, PhD, Principal investigator, La Paz University Hospital; Madrid Autonomous University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184557
- Sponsor's protocol ID
- EC-CS
- Status last verified
- Jul 2021
- First submitted
- 12 Feb 2019
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with other researchers on request
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04184557
- Acronym / sponsor ID
- EC-CS
- Conditions
- Cancer
- Keywords
- cancer, mindfulness, RCT, e-Health, En Calma en el Quirófano, Staying Calm in the OR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly allocated to the intervention arm (app) or to the control arm (treatment as usual [TAU])
| Arm | Type | Receives |
|---|---|---|
| App "Staying Calm in the OR" | Experimental | Behavioral: 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). |
| Treatment as Usual (TAU) | No intervention | –Participants assigned to Treatment As Usual (TAU) arm will not download the app until the study is completed. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 - 100 years old
- Diagnosis of cancer
- Being in waitlist for surgery for less than 14 days
- Signed informed consent
Key exclusion criteria (3 listed)
- 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"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Staying Calm in the ORAlso: En Calma en el Quirófano, EnCalma"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). | Behavioural | App "Staying Calm in the OR" |
Primary outcome
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.
7 secondary outcomes
Change in quality of life
Time frame: From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery)
Change in pain experience
Time frame: From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery)
Presence of post-surgery complications
Time frame: Clavien-Dindo Scale score at hospital discharge (around 7 days after surgery)
Change in blood pressure
Time frame: From surgery to hospital discharge (around 7 days after surgery)
Change in oxygen saturation
Time frame: From surgery to hospital discharge (around 7 days after surgery)
Change in temperature
Time frame: From surgery to hospital discharge (around 7 days after surgery)
Change in analgesia
Time frame: From surgery to hospital discharge (around 7 days after surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Download "En Calma en el Quirófano" for iOSLink provided by the sponsor.
- Download "En Calma en el Quirófano" for AndroidLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be shared with other researchers on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatriz Rodríguez-Vega, PhD principal investigator
La Paz University Hospital; Madrid Autonomous University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staying Calm in the OR in people with Cancer, run by Instituto de Investigación Hospital Universitario La Paz at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety and depression (time frame: From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.