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CaregiversSAECURENCT05839353

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.

An observational study of Caregivers, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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%. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Caregivers
What is being tested?
SBAR training by serious game
How many people
32 participants
Where
1 siteFrance
Study dates
1 Jul 2023to 1 Aug 2025
Phase
Observational
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

France1 site
  • Reunion Island University Hospital

    Saint-Pierre, 97448

    Lucie AUZANNEAU, 0262359949 ext. +262, lucie.auzanneau@chu-reunion.fr

    Danielle REYNAUD

Other trials in France

About this study

Official title: 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.

Conditions
Caregivers
Being tested
SBAR training by serious game

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBAR training by serious gameOther

    SBAR training by serious game

Study groups in NCT05839353
Study groupRoleWhat they receive
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
Receives: Other: SBAR training by serious game
usual instructions issued in routine careUsual instructions issued in routine care, on the management of dyspnea

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 28 days

Secondary outcomes (2)
  1. 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)

    Measured: 28 and 90 days

  2. 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)

    Measured: 28 and 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2023
  2. Study start1 Jul 2023 (estimated)
  3. Primary completion1 Apr 2025 (estimated)
  4. Study completion1 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05839353
Sponsor's protocol ID
2023/CHU/20
Other IDs
2023-A00914-41
Acronym
SAECURE
Status last verified
Jun 2023
First submitted
20 Apr 2023
Last updated
29 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Caregivers, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.

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 4 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: status not confirmed, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lucie AUZANNEAU (0262359949 ext. +262, lucie.auzanneau@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 28 days). 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 29 Jun 2023.

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