SPAMLO-3.0 : Having Fun Shedding Light on Darkness, a Playful Approach to Reduce Anxiety in Palliative Care

Официальное название

SPAMLO-3.0 : Having Fun Shedding Light on Darkness

Обзор

End-of-life care is often accompanied by anxiety-not only for patients in palliative care, but also for their loved ones and the healthcare professionals supporting them. This anxiety may stem from a fear of death, loss of functional abilities, or a worsening of symptoms as the illness progresses. It contributes to emotional, psychological, and physical suffering, ultimately diminishing patients' quality of life. Most data on palliative care focus on cancer patients, among whom anxiety prevalence varies greatly, but may affect more than 70% of individuals. Currently, anxiety in palliative care patients is managed through non-pharmacological approaches (such as environmental modifications and relaxation techniques) and/or pharmacological treatments (including antidepressants, neuroleptics, and anxiolytics). The investigators recently developed the serious game SPAMLO with the aim to present and raise awareness about palliative care. The educational scenario was built around three settings: the hospital, the home, and the nursing home (EHPAD). The participant will follow Vito, a virtual character, whose sister is receiving palliative care. Vito will explore the different types of support available, starting at the hospital. He will learn about what a collegial discussion is, the Clayes-Léonetti law, advance directives, the trusted person, as well as the specificities of pediatrics. Through home hospitalization, Vito will discover palliative care outside the hospital setting, including home adaptations with appropriate equipment and the various available support services. Finally, Vito will visit the nursing home, where topics such as oral care, respecting the patient's choices, and the importance of preserving them will be addressed. Thanks to its playful approach and the knowledge gained, this game could help reduce anxiety in palliative care patients through non-pharmacological means. This research project has beeen co-designed with a JALMALV volunteer (Accompany life until death - french association).

Подробное описание

Participants will be randomly assigned to two groups (at a 1:1 ratio):

Control group: standard care provided by the mobile palliative care team, according to the usual practices of the healthcare team.

Intervention group: standard care by the healthcare team plus participation in the serious game "SPAMLO-3.0."

Participants will have 7 days to complete the game (multiple sessions allowed). Participant's anxiety and secondary outcomes will be measured on Day 15 to assess the primary endpoint.

A second evaluation is planned on day 30 for secondary endpoints. This second assessment will allow participants time to reflect following their participation in the serious game, potentially encouraging the designation of a trusted person and the drafting of advance directives.

Demographic, clinical, therapeutic characteristics, and questionnaires will be collected at inclusion, Day 15, and Day30. The study duration for each participant is 30 days.

Вмешательства

• Поведенческое Serious game
  Participation in the serious game "SPAMLO-3.0."

Первичные конечные точки

• Hospital Anxiety and Depresion Scale [Срок оценки: Day 0, Day 15 and Day 30]

Вторичные конечные точки (7)

• Acceptability of the serious game through a Likert questionnaire [Срок оценки: Day 30]
• Number of participants who completed the serious game. [Срок оценки: Through study completion, an average of 20 months]
• French System Usability Scale [Срок оценки: Through study completion, an average of 20 months]
• McGill Quality of Life Questionnaire [Срок оценки: Day 0, Day 15 and Day 30]
• Insomnia Severity Index [Срок оценки: Day 0 and Day 30]
• Palliative Performance Scale [Срок оценки: Day 0, Day 15 and Day 30]
• Visual analog scale [Срок оценки: Day 0, Day 15 and Day 30]

Критерии участия

Критерии включения

• Participant for whom no curative treatment is proposed, who is either discharged home or hospitalized in palliative care
• Life expectancy presumed to be greater than one month
• No cognitive impairments, according to the healthcare team's assessment
• Participantt has given free and informed consent
• Participant affiliated with a social security system
• The participant owns a computer, tablet, or smartphone with an internet connection and agrees to participate in the serious game SPAMLO-3.0.

Критерии исключения

• Participant who is demented, confused, or in a coma
• Fatigability, according to the healthcare team's assessment
• Visually or hearing impaired participant, according to the healthcare team's assessment
• No inclusion of persons targeted by Articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code (e.g., minors, legally protected adults, etc.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Centre Hospitalier de Saint-Brieuc - Paimpol - Tréguier — Saint-Brieuc

Идентификаторы

NCT: NCT07070869 · 2024_CHSB_SPAMLO-3.0 · 2024-A02381-46

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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