NCT02646527

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

5.7 years

First QC Date

January 4, 2016

Last Update Submit

November 2, 2022

Conditions

Keywords

dignity, end of life, existential, treatment

Outcome Measures

Primary Outcomes (1)

  • The primary outcome will be psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS).

    questionnaire score

    10 days

Secondary Outcomes (1)

  • Health related quality of life (HRQol)

    10 days

Study Arms (3)

DT+

EXPERIMENTAL

Dignity Therapy is conducted with patients and partners

Behavioral: Dignity Therapy

DT

EXPERIMENTAL

Dignity Therapy is conducted only with patients

Behavioral: Dignity Therapy

SPC

NO INTERVENTION

standard palliative care

Interventions

Dignity TherapyBEHAVIORAL

Dignity Therapy (DT) is a brief psychotherapeutic intervention developed by Chochinov (2012) which has been shown to enhance the end of life experience in people with life-limiting conditions. DT focuses on helping patients with terminal illnesses to go over things that are most meaningful to them and document their legacy. Dignity Therapy+ (DT+) involves patient and partner/family asking questions about their most important achievements, roles and other important aspects of life. DT+ encourages patients saying things to loved ones that have remained unsaid. DT+ consists of 3 sessions (1. introduction (30'); 2. main session (60'), 3. final session (30')) and will be conducted by a trained therapist. All therapy session will be audio-taped, transcribed verbatim by the study coordinator, edited by the therapist and returned to the patient or the patient and partner/family as a 'generativity document'.

DTDT+

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (2)

  • Devuyst P, Leiter RE, Milliken A, Jenewein J, Blum D, Seiler A. Narrative identity at the end of life: a qualitative analysis of dignity therapy interviews from an existential perspective. BMC Palliat Care. 2025 Oct 23;24(1):269. doi: 10.1186/s12904-025-01876-2.

  • Seiler A, Amann M, Hertler C, Christ SM, Schettle M, Kaeppeli BM, Jung-Amstutz J, Nigg C, Pestalozzi BC, Imesch P, Dummer R, Blum D, Jenewein J. Effects of dignity therapy on psychological distress and wellbeing of palliative care patients and family caregivers - a randomized controlled study. BMC Palliat Care. 2024 Mar 14;23(1):73. doi: 10.1186/s12904-024-01408-4.

MeSH Terms

Conditions

Death

Interventions

Dignity Therapy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Josef Jenewein, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 5, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2021

Study Completion

May 1, 2022

Last Updated

November 3, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations