Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT07070869
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-17
First Post:
2025-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SPAMLO-3.0 : Having Fun Shedding Light on Darkness, a Playful Approach to Reduce Anxiety in Palliative Care
Sponsor:
Centre Hospitalier de Saint-Brieuc
Organization:
Study Overview
Official Title:
SPAMLO-3.0 : Having Fun Shedding Light on Darkness
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPAMLO 3 0
Brief Summary:
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).
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-A02381-46 | OTHER | ID RCB | View |