SPAMLO-3.0 : Having Fun Shedding Light on Darkness, a Playful Approach to Reduce Anxiety in Palliative Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Serious game.
- Who it may be relevant to
- Registry conditions: Palliative Care, Serious Games, Anxiety. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
SPAMLO-3.0 : Having Fun Shedding Light on Darkness
Overview
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).
Detailed description
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.
Interventions
- Behavioral Serious game
Participation in the serious game "SPAMLO-3.0."
Primary outcome measures
- Hospital Anxiety and Depresion Scale [Time frame: Day 0, Day 15 and Day 30]
Secondary outcome measures (7)
- Acceptability of the serious game through a Likert questionnaire [Time frame: Day 30]
- Number of participants who completed the serious game. [Time frame: Through study completion, an average of 20 months]
- French System Usability Scale [Time frame: Through study completion, an average of 20 months]
- McGill Quality of Life Questionnaire [Time frame: Day 0, Day 15 and Day 30]
- Insomnia Severity Index [Time frame: Day 0 and Day 30]
- Palliative Performance Scale [Time frame: Day 0, Day 15 and Day 30]
- Visual analog scale [Time frame: Day 0, Day 15 and Day 30]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 1 center
- Centre Hospitalier de Saint-Brieuc - Paimpol - Tréguier — Saint-Brieuc
Identifiers
NCT: NCT07070869 · 2024_CHSB_SPAMLO-3.0 · 2024-A02381-46