Effectiveness of a Mindfulness Smartphone App to Reduce Emotional Distress in People With Cancer Waiting for Surgery

NCT04184557 | Completed

• 1 other identifier: EC-CS
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer

Keywords

cancer; mindfulness; RCT; e-Health; En Calma en el Quirófano; Staying Calm in the OR

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery)

Secondary Outcomes (7)

• Change in quality of life

  From baseline (15 days before 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)

• 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)

• Change in oxygen saturation

  From surgery to hospital discharge (around 7 days after surgery)

Other Outcomes (1)

• Level of satisfaction with "Calm Before Surgery"

  Hospital discharge (around 7 days after surgery)

Study Arms (2)

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).

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.

Interventions

Staying Calm in the OR BEHAVIORAL

"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).

Also known as: En Calma en el Quirófano, EnCalma

App "Staying Calm in the OR"

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Diagnosis of cancer
• Being in waitlist for surgery for less than 14 days
• Signed informed consent

You may not qualify if:

• 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"

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (2)

12 Octubre University Hospital

Madrid, 28041, Spain

Location

La Paz University Hospital

Madrid, 28045, Spain

Location

Related Links

• Download "En Calma en el Quirófano" for iOS
• Download "En Calma en el Quirófano" for Android

MeSH Terms

Conditions

Neoplasms

Study Officials

• Beatriz Rodríguez-Vega, PhD

  La Paz University Hospital; Madrid Autonomous University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly allocated to the intervention arm (app) or to the control arm (treatment as usual \[TAU\])

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: December 3, 2019
• Study Start: February 15, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available one year after publishing the final results for at least 5 years
• Access Criteria: Please contact PI Beatriz Rodríguez-Vega (beatrizrvega@gmail.com)

Locations

ES (2)