Clinical trial NCT03744442: Promoting Dignity, Meaningfulness and Mental Well-Being
Official title: Efficacy of a Personalized Modular Intervention to Promote Dignity, Meaningfulness and Mindfulness by a Palliative Care Consultation-Liaison Service in Swiss Acute Hospital Care. A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Life-limiting Serious Illness
Keywords: CALM Therapy
Dignity Therapy
Mindfulness-based intervention
Personalized Modular Intervention
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Stanley Thomas Johnson Stiftung
First posted: 2018-11-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Feasibility study to test the feasibility and acceptability of a designed personalized modular Intervention consisting of three modules, including Cancer and Living Meaningfully (CALM) Therapy, Dignity Therapy (DT), and a mindfulness-based Intervention

Detailed description: Patient with a life-limiting serious illness commonly experience substantial emotional and spiritual distress, death anxieties, depressive symptoms and loss of dignity and purpose in life. Fostering dignity and meaning and relieving psychological distress have been identified as a core objective for end-of-life care. However, individual's needs for dignity and psychological support at the end of life may vary. Therefore, a personalized approach is needed. On the basis of theoretical frameworks and existing dignity- fostering and meaning- based interventions, as well as an one-day workshop with international experts in the field of palliative care, a personalized modular intervention, consisting of three modules, including CALM Therapy, Dignity Therapy, and a mindfulness-based Intervention, was developed.

Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature
* Patients in palliative situation (i.e. patients suffering from an advanced, incurable, life-limiting disease with multimodal support needs)
* Estimated life expectancy ≤ 18 months
* Patients seen by the palliative consultation-liaison service at the University Hospital Basel as an in- or outpatient
* Willingness and capacity to commit at least three contacts over about 7-10 days

Exclusion Criteria:

* Being delirious or otherwise substantially cognitively impaired (based on clinical consensus)
* Being too ill to complete the requirements of the study protocol
* Unable to understand and speak German

Primary outcomes:
measure: Change in acceptability of the personalized modular Intervention (motivation, satisfaction with Intervention, further recommendation)
timeFrame: baseline until 1-month follow- up
measure: Rate of eligibility
timeFrame: at baseline (T0)
measure: Rate of consent
timeFrame: at baseline (T0)
measure: Final recruitment rate
timeFrame: at baseline (T0)
measure: Change in Patient adherence
timeFrame: baseline until 1-month follow- up
measure: Change in Questionnaire completion rates
timeFrame: baseline until 1-month follow- up
Secondary outcomes:
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: baseline until 1-month follow- up
measure: Change in Patient Dignity Inventory (PDI)
timeFrame: baseline until 1-month follow- up
measure: Change in Death and Dying Distress Scale (DADDS)
timeFrame: baseline until 1-month follow- up
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Psychosomatics, University Hospital of Basel
Study officials:
affiliation: Department of Psychosomatic Medicine, University Hospital Basel
name: Sandra Eckstein, Dr. med
role: PRINCIPAL_INVESTIGATOR
References: