Therapeutic Support to Strengthen Dignity, Mental Well-being and Quality of Life in Acute Palliative Care Patients.

August 8, 2024 updated by: University Hospital, Basel, Switzerland

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 dignityfostering and meaning based interventions, and a workshop with international experts in the field of palliative care, we have developed a personalized modular intervention, consisting of three modules, including CALM Therapy, Dignity Therapy, and a mindfulness-based intervention.

The overall purpose of this study is to test the efficacy of the designed personalized modular intervention compared to the specialized palliative care service at the swiss acute palliative hospital care.

Patients are randomized to either receiving standard specialized palliative consultation (SSPC) and the modular intervention or standard palliative consultation services alone. Within the intervention group, participants can choose one of the three modules based on personal preference and the recommendation of the palliative care team (based on assessment). All three interventions consist of two structured sessions.

The control group will receive SSPC alone. 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.

SSPC is performed by specialized inter-professional palliative care service, including doctors and advanced nurse practitioners, certified by national standards for specialist palliative care. Other professions are involved depending on needs. Patients are seen as required at least twice a week.

Patients will be asked to fill in a set of questionnaires at baseline (T0), after the completion of the intervention (T1) and at 1-month follow-up (T2). A brief semi-structured qualitative interview will be conducted with the patients following completion of the intervention to assess perceived benefits and challenges of the intervention.

The primary objective is to evaluate if mental well-being tend to improve over the pre- versus post study design as measured by the Patient Dignity Inventory and if this effect is significantly larger in the modular intervention group as compared to the standard specialized palliative consultation (SSPC) group.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Personnalized modular therapeutic support
Other: Therapeutic support
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.
Other Names:
  • personnalized modular therapeutic support
Other: Standard Specialized Palliative Consultation Service
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.
Active Comparator: Standard Specialized Palliative Consultation Service
Other: Standard Specialized Palliative Consultation Service
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Dignity Inventory
Time Frame: Baseline, after intervention, 4 week follow-up
Questionnaire (Self-reported outcome)
Baseline, after intervention, 4 week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 10, 2024

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2024-01301 (Other Identifier: Ethics Committee North and Central Switzerland)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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