NCT06549075

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
29 days until next milestone

Study Start

First participant enrolled

September 10, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

August 8, 2024

Last Update Submit

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

EXPERIMENTAL
Other: Therapeutic supportOther: Standard Specialized Palliative Consultation Service

Standard Specialized Palliative Consultation Service

ACTIVE COMPARATOR
Other: Standard Specialized Palliative Consultation Service

Interventions

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.

Also known as: personnalized modular therapeutic support
Personnalized modular therapeutic support

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.

Personnalized modular therapeutic supportStandard Specialized Palliative Consultation Service

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Self-Help Groups

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

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