Promoting Dignity, Meaningfulness and Mental Well-Being

University Hospital, Basel, Switzerland10 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Life-limiting Serious Illness

Interventions

Dignity Therapy (DT) modulePROCEDURE

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

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Psychosomatics, University Hospital of Basel

Basel, Switzerland

Outcomes

Primary Outcomes

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)

Time frame: baseline until 1-month follow- up

Rate of eligibility

feasibility of the personalized modular Intervention measured by rate of eligibility

Time frame: at baseline (T0)

Rate of consent

feasibility of the personalized modular Intervention measured by rate of consent

Time frame: at baseline (T0)

Final recruitment rate

feasibility of the personalized modular Intervention measured by final recruitment rate

Time frame: 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)

Time frame: 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)

Time frame: baseline until 1-month follow- up

Secondary Outcomes

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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)

Time frame: 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)

Time frame: 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)

Time frame: baseline until 1-month follow- up