Life-limiting Serious IllnessNCT03744442
Promoting Dignity, Meaningfulness and Mental Well-Being
A study testing Dignity Therapy (DT) module, CALM Therapy module and Mindfulness-based interventions module in people with Life-limiting Serious Illness, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Life-limiting Serious Illness
- What is being tested?
- Dignity Therapy (DT) module, CALM Therapy module and Mindfulness-based interventions module
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Mar 2020to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Psychosomatics, University Hospital of Basel
Basel, 4031
About this study
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
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
Read the 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.
- Conditions
- Life-limiting Serious Illness
- Being tested
- Dignity Therapy (DT) module, CALM Therapy module, Mindfulness-based interventions module
- Keywords
- CALM Therapy, Dignity Therapy, Mindfulness-based intervention, Personalized Modular Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dignity Therapy (DT) moduleProcedure or surgery
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
CALM Therapy moduleProcedure or surgery
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
Mindfulness-based interventions moduleProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Dignity Therapy (DT) module | Active comparator | 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 Receives: Procedure: Dignity Therapy (DT) module |
| CALM Therapy module | Active comparator | 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 Receives: Procedure: CALM Therapy module |
| Mindfulness-based interventions module | Active comparator | 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 Receives: Procedure: Mindfulness-based interventions module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in acceptability of the personalized modular Intervention (motivation, satisfaction with Intervention, further recommendation)
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)
Measured: baseline until 1-month follow- up
Rate of eligibility
feasibility of the personalized modular Intervention measured by rate of eligibility
Measured: at baseline (T0)
Rate of consent
feasibility of the personalized modular Intervention measured by rate of consent
Measured: at baseline (T0)
Final recruitment rate
feasibility of the personalized modular Intervention measured by final recruitment rate
Measured: at baseline (T0)
Change in Patient adherence
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)
Measured: baseline until 1-month follow- up
Change in Questionnaire completion rates
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)
Measured: baseline until 1-month follow- up
Secondary outcomes (3)
Change in Patient Health Questionnaire-9 (PHQ-9)
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)
Measured: baseline until 1-month follow- up
Change in Patient Dignity Inventory (PDI)
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)
Measured: baseline until 1-month follow- up
Change in Death and Dying Distress Scale (DADDS)
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)
Measured: baseline until 1-month follow- up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start5 Mar 2020
- Primary completion30 Sep 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Life-limiting Serious IllnessStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Thomas Johnson Stiftung
- Responsible party
- Sponsor
- Investigators
- Sandra Eckstein, Dr. med, Principal investigator, Department of Psychosomatic Medicine, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744442
- Sponsor's protocol ID
- 2018-01998, va18Eckstein
- Other IDs
- 2018
- Status last verified
- Apr 2024
- First submitted
- 7 Nov 2018
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03744442
- Acronym / sponsor ID
- 2018-01998, va18Eckstein
- Conditions
- Life-limiting Serious Illness
- Keywords
- CALM Therapy, Dignity Therapy, Mindfulness-based intervention, Personalized Modular Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Stanley Thomas Johnson Stiftung
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dignity Therapy (DT) module | Active comparator | Procedure: Dignity Therapy (DT) modulepsychotherapeutic 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 |
| CALM Therapy module | Active comparator | Procedure: CALM Therapy modulesupportive-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 |
| Mindfulness-based interventions module | Active comparator | Procedure: Mindfulness-based interventions moduleMind-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dignity Therapy (DT) modulepsychotherapeutic 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 or surgery | Dignity Therapy (DT) module |
| CALM Therapy modulesupportive-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 or surgery | CALM Therapy module |
| Mindfulness-based interventions moduleMind-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 or surgery | Mindfulness-based interventions module |
Primary outcome
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)
Rate of eligibility
Time frame: at baseline (T0)
feasibility of the personalized modular Intervention measured by rate of eligibility
Rate of consent
Time frame: at baseline (T0)
feasibility of the personalized modular Intervention measured by rate of consent
Final recruitment rate
Time frame: at baseline (T0)
feasibility of the personalized modular Intervention measured by final recruitment rate
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)
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)
3 secondary outcomes
Change in Patient Health Questionnaire-9 (PHQ-9)
Time frame: baseline until 1-month follow- up
Change in Patient Dignity Inventory (PDI)
Time frame: baseline until 1-month follow- up
Change in Death and Dying Distress Scale (DADDS)
Time frame: baseline until 1-month follow- up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
Related trials for Life-limiting Serious Illness
Enrolling by invitation
Group Meaning-Centered Psychotherapy for the Improvement of Wellbeing in Caregivers of Patients With Serious Illness
Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Eckstein, Dr. med principal investigator
Department of Psychosomatic Medicine, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dignity Therapy (DT) module, CALM Therapy module and Mindfulness-based interventions module in people with Life-limiting Serious Illness, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in acceptability of the personalized modular Intervention (motivation, satisfaction with Intervention, further recommendation) (time frame: baseline until 1-month follow- up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.