Promoting Dignity, Meaningfulness and Mental Well-Being

April 10, 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 Feasibility Study

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Department of Psychosomatics, University Hospital of Basel

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Dignity Therapy (DT) module
psychotherapeutic intervention asking patients about their most important achievements, roles and other important aspects of life; two structured sessions of 60 minutes conducted by a trained therapist
Procedure: Dignity Therapy (DT) module
psychotherapeutic intervention asking patients about their most important achievements, roles and other important aspects of life; two structured sessions of 60 minutes conducted by a trained therapist
Active Comparator: CALM Therapy module
supportive-expressive psychotherapy aiming to help (1) manage the disease, symptom and treatment, and communicate with healthcare providers, to (2) adjust to changes in self-concept, personal relationships, and support needs, to (3) find a sense of meaning and purpose in life, and to (4) prepare for the future, sustain hope, and face the end of life; two structured sessions of 60 minutes conducted by a trained therapist
Procedure: CALM Therapy module
supportive-expressive psychotherapy aiming to help (1) manage the disease, symptom and treatment, and communicate with healthcare providers, to (2) adjust to changes in self-concept, personal relationships, and support needs, to (3) find a sense of meaning and purpose in life, and to (4) prepare for the future, sustain hope, and face the end of life; two structured sessions of 60 minutes conducted by a trained therapist
Active Comparator: Mindfulness-based interventions module
Mind-body techniques reducing existential and spiritual distress and dealing with common experiences related to life-limiting diseases, including loss of control, uncertainty about the future; two structured sessions of 60 minutes conducted by a trained therapist
Procedure: Mindfulness-based interventions module
Mind-body techniques reducing existential and spiritual distress and dealing with common experiences related to life-limiting diseases, including loss of control, uncertainty about the future; two structured sessions of 60 minutes conducted by a trained therapist

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in acceptability of the personalized modular Intervention (motivation, satisfaction with Intervention, further recommendation)
Time Frame: baseline until 1-month follow- up
Motivation for participating in the study, Satisfaction with the intervention, and If intervention would be recommended to other patients, measured by a semi-structured interview; assessment at baseline (T0), after the completion of the intervention (T1 = 2 weeks after baseline) and at 1-month follow- up (T2)
baseline until 1-month follow- up
Rate of eligibility
Time Frame: at baseline (T0)
feasibility of the personalized modular Intervention measured by rate of eligibility
at baseline (T0)
Rate of consent
Time Frame: at baseline (T0)
feasibility of the personalized modular Intervention measured by rate of consent
at baseline (T0)
Final recruitment rate
Time Frame: at baseline (T0)
feasibility of the personalized modular Intervention measured by final recruitment rate
at baseline (T0)
Change in Patient adherence
Time Frame: baseline until 1-month follow- up
feasibility of the personalized modular Intervention measured by rate of drop- Outs; assessment at baseline (T0), after the completion of the intervention (T1 = 2 weeks after baseline) and at 1-month follow- up (T2)
baseline until 1-month follow- up
Change in Questionnaire completion rates
Time Frame: baseline until 1-month follow- up
feasibility of the personalized modular Intervention measured by rate of completion of questionnaire and expenditure of time for completing questionnaire (in minutes); assessment at baseline (T0), after the completion of the intervention (T1 = 2 weeks after baseline) and at 1-month follow- up (T2)
baseline until 1-month follow- up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Patient Health Questionnaire-9 (PHQ-9)
Time Frame: baseline until 1-month follow- up
PHQ-9 is a 9-question instrument given to patients to screen for the presence and severity of Depression. Scores Depression severity from 0 (=none) to 27 (severe); assessment at baseline (T0), after the completion of the intervention (T1 = 2 weeks after baseline) and at 1-month follow- up (T2)
baseline until 1-month follow- up
Change in Patient Dignity Inventory (PDI)
Time Frame: baseline until 1-month follow- up
25-item PDI measurement of various sources of dignity-related distress among patients nearing the end of life; each item rated on a five-point scale (1=not a problem; 2= a slight problem; 3=a problem; 4=a major problem; 5=an overwhelming problem); assessment at baseline (T0), after the completion of the intervention (T1 = 2 weeks after baseline) and at 1-month follow- up (T2)
baseline until 1-month follow- up
Change in Death and Dying Distress Scale (DADDS)
Time Frame: baseline until 1-month follow- up
15-item scale to assess concerns related to death and dying in patients with advanced cancer. Items are answered on a 6-point scale from 0 (no distress) to 5 (extreme distress). Total scores may range from 0 to 75 and scores ≥45 refer to the presence of at least moderate death anxiety. Assessment at baseline (T0), after the completion of the intervention (T1 = 2 weeks after baseline) and at 1-month follow- up (T2)
baseline until 1-month follow- up

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Stanley Thomas Johnson Stiftung

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sandra Eckstein, Dr. med, Department of Psychosomatic Medicine, University Hospital Basel

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-01998, va18Eckstein

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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