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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier de Saint-Brieuc

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Serious game

    Behavioral

    Participation in the serious game "SPAMLO-3.0."

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

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.

Time frame
Day 0, Day 15 and Day 30

Secondary outcomes

1

Acceptability of the serious game through a Likert questionnaire

Likert questionnaire completed by the participant

Time frame
Day 30
2

Number of participants who completed the serious game.

Data obtained by the coordinating investigator

Time frame
Through study completion, an average of 20 months
3

French System Usability Scale

Healthcare team's perception of the use of the serious game. The questionnaire includes ten items, each formulated as a statement. For each statement, the user is asked to indicate their level of agreement or disagreement using a 5-point Likert scale (1 = Strongly disagree; 5 = Strongly agree). If the user is unsure how to respond to an item, they are encouraged to answer anyway by selecting the middle point of the scale (score 3).

Time frame
Through study completion, an average of 20 months
4

McGill Quality of Life Questionnaire

Completed by the participant. It is a 17-item multidimensional tool designed to measure physical well-being, physical symptoms, psychological symptoms, existential well-being and support, as well as overall quality of life. The scores for each domain are calculated separately.

Time frame
Day 0, Day 15 and Day 30

Other outcomes

Sponsors and contacts

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