Clinical trial NCT02646527: Dignity Therapy+: A Brief Psychological and Existential Intervention for Dying Patients and Their Families.
Official title: Dignity Therapy+: a Brief Psychological and Existential Intervention for Dying Patients and Their Families. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Keywords: dignity, end of life, existential, treatment
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss Cancer League
First posted: 2016-01-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: There has been significant progress in symptom management, pain relief and improvement of quality of life in patients nearing death by implementing palliative care programs. Existential and dignity related issues, such as loss of autonomy and sense of meaning or feeling a burden to others are frequent reasons for psychological distress and desire for hastened death. Dignity Therapy (DT), developed by Chochinov et al., is a brief, individualized psychotherapy for the purpose of relieving distress by directly addressing dignity conserving factors.

Aims: To test whether the inclusion of a patient's partner or designated family member into Dignity Therapy (DT+) could mitigate psychological distress (anxiety and depression) in both, the patient nearing the end of his life experiencing increased psychological distress and the patient's partner/family member compared to the control groups receiving Dignity Therapy in the single setting (DT) or standard palliative care (SPC).

Methods and design: In this randomized controlled trial a total of 159 patients with a diagnosis of an advanced disease and poor prognosis (life expectancy \< 6 months) who receive palliative care either in the Palliative Care Centre of the University Hospital Zurich (USZ) or the Clinic Susenberg, Zurich, or in the "Lighthouse" Hospice Zurich, will be randomly assigned to either DT+, DT, or SPC in a 1:1:1 ratio. Patients will be pre-screened and included if they report increased psychological distress (anxiety, depression using the Hospital Anxiety and Depression Scale=HADS). The therapy is guided by trained therapists and consists of 3 audiotaped sessions. The main focus of the intervention is to invite patients to reflect on their most important achievements, roles or other things in their lives or things that they would most want remembered. On completion, the audiorecording is transcribed and edited to provide a clear and readable narrative, the generativity document, which can be passed to a person of the patient's choice. DT+, in contrast to the original intervention developed by Chochinov et al., is a systemic approach in which patient's partners or designated family members are included.


Eligibility criteria: Inclusion Criteria:

* Informed Consent
* Diagnosis of advanced cancer and life expectancy \< 6 months
* Receiving palliative care at the Palliative Care Centre or oncological wards at the University Hospital Zurich, the Susenberg Clinic, or Zurich 'Lighthouse' Hospice
* ≥ 18 years of age
* HADS score ≥ 8

Exclusion Criteria:

* Delirious (ICD-10: F05.9)
* Cognitively impaired
* Too ill to complete the requirements of the protocol
* Unable to speak and read German

Primary outcomes:
measure: The primary outcome will be psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS).
timeFrame: 10 days
Secondary outcomes:
measure: Health related quality of life (HRQol)
timeFrame: 10 days
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Josef Jenewein, MD
role: PRINCIPAL_INVESTIGATOR
References: