Palliative CareDT-plusNCT02646527
Dignity Therapy+: A Brief Psychological and Existential Intervention for Dying Patients and Their Families.
A study testing Dignity Therapy in people with Palliative Care, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care
- What is being tested?
- Dignity Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2016to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Delirious (ICD-10: F05.9)
- Cognitively impaired
- Too ill to complete the requirements of the protocol
- Unable to speak and read German
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dignity Therapy+: a Brief Psychological and Existential Intervention for Dying Patients and Their Families. A Randomized Controlled Trial
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.
- Conditions
- Palliative Care
- Being tested
- Dignity Therapy
- Keywords
- dignity, end of life, existential, treatment
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dignity TherapyBehavioural
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'.
| Study group | Role | What they receive |
|---|---|---|
| DT+ | Experimental | Dignity Therapy is conducted with patients and partners Receives: Behavioral: Dignity Therapy |
| DT | Experimental | Dignity Therapy is conducted only with patients Receives: Behavioral: Dignity Therapy |
| SPC | No intervention | standard palliative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS).
questionnaire score
Measured: 10 days
Secondary outcomes (1)
Health related quality of life (HRQol)
questionnaire score
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2021
- Study completionMay 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Cancer League
- Responsible party
- Sponsor
- Investigators
- Josef Jenewein, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646527
- Sponsor's protocol ID
- KEK-ZH-2015-0416
- Acronym
- DT-plus
- Status last verified
- Nov 2022
- First submitted
- 4 Jan 2016
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 41131554Seiler 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.
PubMed 38486192
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dignity Therapy+: a Brief Psychological and Existential Intervention for Dying Patients and Their Families. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02646527
- Acronym / sponsor ID
- DT-plus / KEK-ZH-2015-0416
- Conditions
- Palliative Care
- Keywords
- dignity, end of life, existential, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss Cancer League
- Study start
- Apr 2016
- Primary completion
- Dec 2021 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 5 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DT+ | Experimental | Behavioral: Dignity TherapyDignity Therapy is conducted with patients and partners |
| DT | Experimental | Behavioral: Dignity TherapyDignity Therapy is conducted only with patients |
| SPC | No intervention | –standard palliative care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Delirious (ICD-10: F05.9)
- Cognitively impaired
- Too ill to complete the requirements of the protocol
- Unable to speak and read German
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dignity TherapyDignity 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'. | Behavioural | DT, DT+ |
Primary outcome
The primary outcome will be psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS).
Time frame: 10 days
questionnaire score
1 secondary outcome
Health related quality of life (HRQol)
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 41131554Devuyst 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.
- Derived from this study: PubMed 38486192Seiler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josef Jenewein, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dignity Therapy in people with Palliative Care, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS). (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02646527, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.