Evaluation of the Effect of Training in the Situation Background Assessment Recommendation (SBAR) Tool on the Feeling of Self-efficacy of Carers of Patients With Lung Cancer in the Face of a Situation of Simulated Respiratory Distress. (SAECURE)

Evaluation of the Effect of Training in the SBAR (Situation Background Assessment Recommendation) Tool on the Feeling of Self-efficacy of Carers of Patients With Lung Cancer in the Face of a Situation of Simulated Respiratory Distress.

Dyspnea is defined as a subjective feeling of discomfort in breathing. In respiratory pathologies, dyspnea can be indicative of lung cancer or its aggravation, or even be the most important symptom of the end of life. The prevalence of dyspnea is high in patients with lung cancer, ranging from 50 to 87%. Dyspnea can exacerbate at any time in the course of care for the patient with lung cancer, causing respiratory distress or Acute Respiratory Failure (ARF) and putting the prognosis at stake. ARF justifies urgent and effective care, and in pre-hospital, it is based on the call to the Emergency Medical Aid Service (SAMU). The communication of information on the patient's condition in ARF to the SAMU must be as clear and precise as possible in order to avoid medical errors, inappropriate decisions and therefore a loss of opportunity for the patient. In Oncology, caregivers often assume the role of "decision maker" and provide monitoring and assessment of symptoms, including dyspnea.

A qualitative study on the experience of caregivers during dyspnea occurring in patients with lung cancer or obstructive bronchopneumopathy revealed an altered emotional state of caregivers, such as anxiety, stress and feeling of helplessness, especially when respiratory deterioration occurs suddenly at night. The unmet need for information could compromise the sense of self-efficacy among caregivers.

In this context of monitoring symptoms in lung cancer at home, caregivers are the first witnesses of respiratory distress in their loved ones. However, faced with the sudden deterioration of breathing, they risk forgetting to communicate essential information when calling the SAMU. Since 2014, the High Authority for Health (HAS) has been recommending the use of the SBAR tool (Situation, Background, Assessment Recommendation) to facilitate communication between professionals. Its effectiveness has been proven both in improving knowledge and in the quality of communication. This is why training in the use of the SBAR (Situation, Background, Assessment Recommendation) tool could be extrapolated to caregivers with regard to the responsibilities they must assume in the management of home care, including lung cancer to deal with respiratory distress.The Serious Game (SG) is an innovative educational tool adapted to training in the field of health.It is an interactive web-based software allowing the repetitive training of medical procedures in a virtual environment, in the form of video games for active, experiential and problem-based learning, without the need to involve patients and therefore without risk.The aim of the research is to provide training in the SBAR (Situation, Background, Assessment Recommendation) tool in the form of a Serious Game for carers of patients with lung cancer in order to improve the feeling of self-efficacy in the management of respiratory distress at home.

Study Overview

• Status: Not yet recruiting
• Conditions: Caregivers
• Intervention / Treatment: Other: SBAR training by serious game

• Study Type: Observational
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucie AUZANNEAU; Phone Number: +262 0262359949; Email: lucie.auzanneau@chu-reunion.fr

Study Locations

• France
  • Saint-Pierre, France, 97448
    • Reunion Island University Hospital
    • Principal Investigator: Danielle REYNAUD
    • Contact: Lucie AUZANNEAU; Phone Number: +262 0262359949; Email: lucie.auzanneau@chu-reunion.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Designated as a resource person by a patient newly diagnosed with lung cancer

Description

Inclusion Criteria:

• Over 18 years old
• Designated as a resource person by a patient newly diagnosed with lung cancer and receiving their first course of anti-cancer treatment (chemotherapy, hormone therapy or targeted therapy)
• Providing daily unpaid technical, psychological and social assistance
• Having given free, informed, express oral consent

Exclusion Criteria:

• Person deprived of liberty by judicial or administrative decision, and person subject to legal protection (guardianship or curators)
• Having a cancerous pathology
• Illiterate
• Do not have access to computer equipment (computer, tablet or smart phone)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
simulated training by Serious Game (SG); Simulated training (by SG) for the use of the SBAR tool associated with the usual instructions issued in routine care, on the management of dyspnea	Other: SBAR training by serious game; SBAR training by serious game
usual instructions issued in routine care; Usual instructions issued in routine care, on the management of dyspnea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of training in the SBAR tool by serious game on the feeling of self-efficacy of carers of patients with lung cancer in the face of a situation of simulated respiratory distress.	Generalized Self-Efficacy (GSE) scale _ 10 question / minimum value = 10 ; maximum value = 40 / Higher scores mean a better outcome (high sense of self-efficacy)	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of training in the SBAR tool by serious game on anxiety	Hospital Anxiety and Depression Scale (HADS) _ 14 question / minimum value = 7 or mean ; maximum value > 11 / Higher scores mean a worse outcome (high anxiety and depression)	28 and 90 days
Effect of training in the SBAR tool by serious game on stress	Perceived Stress Scale-10 (PSS 10) _ 10 question / minimum value = 0 ; maximum value = 40 / Higher scores mean a worse outcome (high stress)	28 and 90 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion
• Investigators: Principal Investigator: Danielle REYNAUD, CHU Reunion Island

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: April 20, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2023/CHU/20; 2023-A00914-41 (Other Identifier: id-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No