Therapeutic Support to Strengthen Dignity, Mental Well-being and Quality of Life in Acute Palliative Care Patients.
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 Randomized Controlled Trial
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
The goal of this clinical trial is to test the benefit of a newly designed personalized therapeutic intervention compared to the standard specialized palliative care service at the swiss acute palliative hospital care.The main questions it aims to answer are: Does an additional therapeutic support that fits the individual needs of a palliative care patient increases dignity and mental well-being as measures by a questionnaire (Patient Dignity Inventory) to a larger extent than standard palliative care alone? Is the additional therapeutic support perceived as helpful? Researchers will compare the additional therapeutic support with standard palliative care to standard palliative care alone. Participants will: Receive additional therapeutic support in two structured sessions a 60 minutes and/or standard palliative care Fill out questionnaires before and after therapeutic interventions and standard palliative care Provide a semi-structured interview following the therapeutic support
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2024
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2024
CompletedFirst Posted
Study publicly available on registry
August 12, 2024
CompletedStudy Start
First participant enrolled
September 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedAugust 12, 2024
August 1, 2024
6 months
August 8, 2024
August 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Patient Dignity Inventory
Questionnaire (Self-reported outcome)
Baseline, after intervention, 4 week follow-up
Study Arms (2)
Personnalized modular therapeutic support
EXPERIMENTALStandard Specialized Palliative Consultation Service
ACTIVE COMPARATORInterventions
The modular intervention consists of three modules, including Dignity Therapy, CALM Therapy and Mindfulness-based training. According to the patient's preferences, the patient will be allocated to one of the three interventions, which will be conducted by trained therapists within two sessions.
According to needs standard specialized palliative care will include support of symptom control, shared decision making/ advance care planning, network planning and support of relatives.
Eligibility Criteria
You may qualify if:
- Informed Consent
- Patients seen by the palliative consultation-liaison service at the University Hospital Basel as an in- or outpatient
- Suffering from a life-limiting serious illness (≤ 18 months)
- ≥ 18 years of age
- Willingness and capacity to commit to three study visits
You may not qualify if:
- Delirious (ICD-10: F05.9)
- Inability to give consent (lack of decisional capacity to consent)
- Inability to follow the procedures of the study due to psychological disorders, dementia, or other cognitively impairment of the participant,
- Too ill to complete the requirements of the protocol
- Unable to understand, speak and read German
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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
August 8, 2024
First Posted
August 12, 2024
Study Start
September 10, 2024
Primary Completion
February 28, 2025
Study Completion
April 30, 2025
Last Updated
August 12, 2024
Record last verified: 2024-08