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Palliative CareSPAMLO 3 0NCT07070869

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

A study testing Serious game in people with Palliative Care and Serious Games, run by Centre Hospitalier de Saint-Brieuc at 8 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Palliative Care, Serious Games, Anxiety
What is being tested?
Serious game
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
8 sitesFrance
Study dates
Jul 2027to Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Fanny BEGUIER contact

0296018165 ext. +33

fanny.beguier@armorsante.bzh

8 sites in 1 country

France8 sites, 8 recruiting

  • Groupe Hospitalier Rance Emeraude, site René Plevin

    Dinan, 22100

    Angélique DIMITRU-MARIN

    Recruiting

  • Centre Hospitalier de Guingamp

    Guingamp, 22200

    Etienne BAUDRY, Dr

    Recruiting

  • Centre Hospitalier de Lannion - Trestel

    Lannion, 22300

    Johann COSTE, Dr

    Recruiting

  • Centre Hospitalier Centre Bretagne

    Noyal-Pontivy, 56920

    Radu-Ioan VANICA, Dr

    Recruiting

  • Centre Hopsitalier de Saint-Brieuc - Paimpol - Tréguier, site de Paimpol

    Paimpol, 22500

    Pierre KERGARAVAT, Dr

    Recruiting

  • Centre Hospitalier Universitaire de Rennes, site de la Tauvrais

    Rennes, 35000

    Vincent MOREL, Pr

    Recruiting

  • Centre Hospitalier de Saint-Brieuc - Paimpol - Tréguier, site de Saint-Brieuc

    Saint-Brieuc, 22000

    Gwenaëlle LE GARFF, 0296018048 ext. +33, gwenaelle.legarff@armorsante.bzh

    Marie-Pierre DUBAN, 0296018434 ext. +33, marie-pierre.duban@armorsante.bzh

    Recruiting

  • HAD du Pays Briochin - Fondation AUB Santé

    Saint-Brieuc, 22000

    Jimmy SOLO

    Recruiting

Other trials in France

About this study

Official title: SPAMLO-3.0 : Having Fun Shedding Light on Darkness

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.

Read more

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).

Read the 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.

Being tested
Serious game
Keywords
anxiety, serious game, palliative care
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Serious gameBehavioural

    Participation in the serious game "SPAMLO-3.0."

Study groups in NCT07070869
Study groupRoleWhat they receive
Intervention groupExperimentalStandard care by the healthcare team and participation in the serious game "SPAMLO-3.0."
Receives: Behavioral: Serious game
Control groupNo interventionStandard care provided by the mobile palliative care team, according to the usual practices of the healthcare team.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 0, Day 15 and Day 30

Secondary outcomes (7)

  1. Acceptability of the serious game through a Likert questionnaire

    Likert questionnaire completed by the participant

    Measured: Day 30

  2. Number of participants who completed the serious game.

    Data obtained by the coordinating investigator

    Measured: 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).

    Measured: 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.

    Measured: Day 0, Day 15 and Day 30

  5. Insomnia Severity Index

    Completed by the participant. The first item assesses the intensity of insomnia complaints separately for difficulty falling asleep, maintaining sleep, and early awakening. One item evaluates the subject's overall satisfaction with their sleep, and another item assesses concerns regarding insomnia. Finally, two items evaluate the impact on daily life activities. Each item is rated by the patient from 0 to 4.The total score ranges from 0 to 28.

    • between 0 and 7 indicates the absence of clinically significant insomnia complaints,
    • between 8 and 14 indicates subclinical (mild) insomnia complaints,
    • between 15 and 21 indicates clinically significant (moderate) insomnia complaints,
    • between 22 and 28 indicates severe insomnia complaints.

    Measured: Day 0 and Day 30

  6. Palliative Performance Scale

    Completed by investigators. This is an 11-point scale used to measure a patient's performance in 10% increments, with 100% representing health and 0% representing death. The scale is based on five observable parameters: mobility, activity level, independence in personal care, feeding, and level of consciousness.

    Measured: Day 0, Day 15 and Day 30

  7. Visual analog scale

    Evaluated by the participant.

    This scale measures pain intensity on a scale from 0 to 10. The correspondence between VAS (Visual Analog Scale) levels and pain intensity is as follows:

    • between 1 and 3: mild pain intensity
    • between 3 and 5: moderate pain intensity
    • between 5 and 7: severe pain intensity
    • above 7: very severe pain

    Measured: Day 0, Day 15 and Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2025
  2. Study startJul 2027 (estimated)
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07070869
Sponsor's protocol ID
2024_CHSB_SPAMLO-3.0
Other IDs
2024-A02381-46
Acronym
SPAMLO 3 0
Status last verified
Oct 2026
First submitted
30 Jun 2025
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Serious game in people with Palliative Care and Serious Games, run by Centre Hospitalier de Saint-Brieuc at 8 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fanny BEGUIER (0296018165 ext. +33, fanny.beguier@armorsante.bzh), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital Anxiety and Depresion Scale (time frame: Day 0, Day 15 and Day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07070869.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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