Dignity Therapy+: A Brief Psychological and Existential Intervention for Dying Patients and Their Families.

Palliative Care Clinical Trial

— DT-plus  

Official title:

Dignity Therapy+: a Brief Psychological and Existential Intervention for Dying Patients and Their Families. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02646527
• Other study ID #: KEK-ZH-2015-0416
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: May 2022

Study information

• Verified date: November 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Palliative Care

Intervention

Behavioral:
• Dignity Therapy
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'.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Swiss Cancer League

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS).	questionnaire score	10 days
Secondary	Health related quality of life (HRQol)	questionnaire score	10 days