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Completed

NCT Number: NCT03744442

Promoting Dignity, Meaningfulness and Mental Well-Being

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

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Key information

Conditions

Life-limiting Serious Illness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychosomatics, University Hospital of Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dignity Therapy (DT) module

Procedure

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 module

Procedure

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 module

Procedure

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

Primary outcomes

  1. 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)

  2. Rate of eligibility

    Time frame: at baseline (T0)

    feasibility of the personalized modular Intervention measured by rate of eligibility

  3. Rate of consent

    Time frame: at baseline (T0)

    feasibility of the personalized modular Intervention measured by rate of consent

  4. Final recruitment rate

    Time frame: at baseline (T0)

    feasibility of the personalized modular Intervention measured by final recruitment rate

  5. 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)

  6. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Stanley Thomas Johnson Stiftung

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 16, 2018
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.