Promoting Dignity, Meaningfulness and Mental Well-Being

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Life-limiting Serious Illness

Intervention / Treatment
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* Procedure: Dignity Therapy (DT) module
* Procedure: CALM Therapy module
* Procedure: Mindfulness-based interventions module


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dignity Therapy (DT) module<br>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<br>* 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<br>|
| Active Comparator: CALM Therapy module<br>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<br>* 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<br>|
| Active Comparator: Mindfulness-based interventions module<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | baseline until 1-month follow- up | 
| Rate of eligibility | feasibility of the personalized modular Intervention measured by rate of eligibility | at baseline (T0) | 
| Rate of consent | feasibility of the personalized modular Intervention measured by rate of consent | at baseline (T0) | 
| Final recruitment rate | feasibility of the personalized modular Intervention measured by final recruitment rate | 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) | 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) | baseline until 1-month follow- up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | baseline until 1-month follow- up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CALM Therapy, Dignity Therapy, Mindfulness-based intervention, Personalized Modular Intervention