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

NCT07070869 | Not Yet Recruiting

• 2 other identifiers: 2024_CHSB_SPAMLO-3.02024-A02381-46
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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).

Conditions

Palliative Care; Serious Games; Anxiety

Keywords

anxiety; serious game; palliative care

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depresion Scale

  Questionnaire completed by the participant. It consists of 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and the other seven to the depressive dimension (total D), thus allowing for the calculation of two scores (maximum score for each = 21). The scores for each of the Anxiety and Depression subscales are interpreted as follows: 0 to 7: no signs of anxiety and/or depressive disorders. 8 to 10: borderline or doubtful symptomatology. 11 to 21: confirmed anxiety and/or depressive disorders of varying severity.

  Day 0, Day 15 and Day 30

Secondary Outcomes (7)

• Acceptability of the serious game through a Likert questionnaire

  Day 30

• Number of participants who completed the serious game.

  Through study completion, an average of 20 months

• French System Usability Scale

  Through study completion, an average of 20 months

• McGill Quality of Life Questionnaire

  Day 0, Day 15 and Day 30

• Insomnia Severity Index

  Day 0 and Day 30

Study Arms (2)

Intervention group

EXPERIMENTAL

Standard care by the healthcare team and participation in the serious game "SPAMLO-3.0."

Behavioral: Serious game

Control group

NO INTERVENTION

Standard care provided by the mobile palliative care team, according to the usual practices of the healthcare team.

Interventions

Serious game BEHAVIORAL

Participation in the serious game "SPAMLO-3.0."

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Saint-Brieuc: lead

Study Sites (1)

Centre Hospitalier de Saint-Brieuc - Paimpol - Tréguier

Saint-Brieuc, 22000, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Stéphanie LOUICHE

  Centre Hospitalier de Saint-Brieuc - Paimpol - Tréguier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fanny BEGUIER

CONTACT

0296018165; fanny.beguier@armorsante.bzh

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 17, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

FR (1)