Condition category
Mental and Behavioural Disorders
Date applied
06/09/2011
Date assigned
19/09/2011
Last edited
25/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Terminally-ill patients are confronted with different types of feelings. Psychological and existential suffering (for example, depression, anxiety, feeling of hopelessness and helplessness) are one of the most debilitating conditions in dying patients, although they tend to be under-recognised and they are difficult to take care of. They cause suffering in terminally-ill patients and their families, reducing quality of life, increasing pain and other symptoms. Dignity is one of the basic requirements that must be provided when caring for terminally-ill patients. The dignity model developed by Chochinov is a brief individualised intervention designed to address psychosocial and existential distress among terminally-ill patients. Some studies have taken place in Canada, USA and Australia. Europe is lacking the evidence to show that this model works well and there is no data in Portugal.
In our trial we proposed to perform a long term follow-up (30 days) to study the possible maintenance of the psychotherapeutic effect on various measures of psychosocial and existential distress. The main aim of this study is to assess how well dignity therapy works for people with a life-threatening disease who have been referred to an in-patient palliative medicine unit. The study will include a long term follow-up (30 days). The expected usefulness of dignity therapy as part of regular palliative care programs will be measured in terms of health benefits (reduced psychological suffering and improved quality of life).

Who can participate?
Patients who are admitted to our palliative medicine unit and have the following criteria:
• age ≥ 18 years old
• life-threatening disease
• able to read and speak Portuguese
• able to provide written informed consent
• no evidence or diagnosis of dementia or delirium
• available for 4 to 5 research meetings, over a period of one month

What does the study involve?
By accepting to participate in this study, patients will randomly be allocated to one of two groups:
• Intervention group, consisting of dignity therapy and standard palliative care or
• Control group, consisting only of standard palliative care
Both groups will receive medical treatment as usual (standard palliative care).
Patients allocated to dignity therapy are asked to tape-record aspects of their lives they would most want their loved ones to remember. To decrease suffering, enhance quality of life, sense of meaning, purpose and dignity, patients are offered the opportunity to talk in a very flexible way about issues that matter the most to them, that they feel were the most important and meaningful moments of their lives, to speak to things they would like to be remembered after their death or even dispense advice to their family and friends. The tape-recorded psychotherapy sessions generate an edited transcript (generativity document) that is returned to the patient for them to share with the individuals of their choosing.
Standard palliative care consists of a multi-professional palliative medicine team assessment, including nurses, a psychologist, a psychosocial worker and clinical care delivered by the doctor. Clinical care consists of clinical interview, physical examination, symptom assessment and management, addressing patients’ and families’ questions, understanding of illness and treatment, existential and psychosocial support.

What are the possible benefits and risks of participating?
There are no known risks to participants.
All participants, including controls, will receive state-of-the-art palliative care and will see improvements in their quality of life and comfort, as their physical and psychological symptoms are managed.

Where is the study run from?
The study takes place at a ten bed specialized palliative medicine in the surroundings of Lisbon, Portugal.

When is study starting and how long is it expected to run for?
The study will run from May 2010 until May 2013.

Who is funding the study?
This is an investigator funded study.

Who is the main contact?
Dr. Miguel Julião
migueljuliao@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Miguel Julião

ORCID ID

Contact details

Rua Pedro Hispano
19
7º esq
Carnaxide
2790-250
Portugal
migueljuliao@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Efficacy of dignity therapy in psychological and existential distress of terminally-ill patients: randomized controlled trial

Acronym

Study hypothesis

The aim of our study was to assess the long term efficacy of dignity therapy (DT) in reducing psychological and existential distress in people with a life-threatening disease who have been referred to an in-patient palliative care unit. We also performed a brief feasibility analysis of DT including a qualitative analysis of the content of the generativity documents.

Ethics approval

1. Instituto das Irmãs Hospitaleiras do Sagrado Coração de Jesus Ethics Committee - Casa de Saúde da Idanha, 26 May 2010
2. Faculty of Medicine, University of Lisbon Ethics Committee, 07 May 2010

Study design

Phase II open-label randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Psychological and existential distress of terminally-ill patients

Intervention

Standard palliative care:
Standard palliative care (SPC) consisted of a multi-professional palliative care team assessment, including nurses, a psychologist, a psychosocial worker and clinical care delivered by the main investigator. Clinical care (median=20 minutes; range 10-30) consisted of clinical interview, physical examination, symptom assessment and management, addressing patients and families questions as well as family and patients coping, illness and treatment understanding, existential and psychosocial support.

SPC during the RCT protocol was always performed by the main investigator and by neither of the other two doctors in the palliative care team.

Dignity therapy:
DT is a brief psychotherapeutic approach with the aim of bolstering the patient´s sense of meaning and purpose, reinforcing a continued sense of worth within a framework that is supportive, nurturing and accessible for those proximate to death. Therapeutic sessions, running between 30 and 60 minutes,were offered at patients´ bedside. DT was tape-recorded after written informed consent was obtained. Every tape-recorded session was erased after the completion of the study protocol.

The standard framework of questions outlined in DT interview was based on the themes and sub-themes that arise from the dignity model 9. Once patients completed the baseline assessment (T1), they were provided with the standard framework of questions, thus giving them time to reflect and shape eventual responses.

The taped session of DT began with the question – “Tell me a little about your life history, particularly the parts that you either remember or think were most important?”. After this introductory question, the question framework provided a flexible guide to the therapist to shape the interview, based on the level of explicit interest of each answer. The therapist followed the patients’ cues, helping them to structure and organizes their thoughts (local and time sequences, p.e.). The therapist main task was to “connect the dots” facilitating the disclosure of feelings, thoughts and memories. Another metaphor used to enrich patients’ ability to describe their life details was asking – “Imagine that you and I are looking at a picture book or album of your life. Tell me in as much detail as you can about some of the
pictures we might see”.

Once the taped session was complete, over the course of the next 2 to 3 days, the patients´ recorded dialogue was transcribed verbatim and then reshaped into a written narrative, after an editing process. This editing process included elimination of nonstarters and colloquialisms, chronological corrections, tagging and editing any harmful or conflictive statement for the generativity document recipient. Once this editing process was complete, another session was arranged in a short time period for the therapist to read the document to the patient, allowing editorial corrections, including identifying possible errors.

During this RCT, DT was performed as previously described only by the main Investigator who received formal training in DT with Harvey Chochinov. The RCT protocol was only performed during the main Investigator´s working hours in the palliative care unit (2 days a week). During these two week periods, the main Investigator would perform DT and SPC on the same day (to patients on intervention group and control group).

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

To determine the efficacy of DT in reducing depression symptoms

Secondary outcome measures

1. The efficacy of DT on the following psychosocial and existential aspects: anxiety symptoms; demoralization; desire for death; sense of dignity; patients’ satisfaction, helpfulness, sense of meaning and purpose after performing dignity therapy; and physical symptoms.
1.1. Depression and anxiety: Hospital and Anxiety Depression Scale (HADS)
1.2. Demoralization: Demoralization Criteria
1.3. Desire for Death: Desire for Death Rating Scale (DDRS)
1.4. Sense of Dignity: Patient Dignity Inventory (PDI)
1.5. Satisfaction with dignity therapy: Patient Dignity Questionnaire (PDQ)
1.6. Physical Symptoms: Edmonton Symptom Assessment Scale (ESAS)
2. The prevalence of depression, anxiety, demoralization and desire for death
3. Brief feasibility analysis of DT and a qualitative analysis of the content of all generativity documents

Day 1: collection of demographic and clinical data (T0)
Day 2: baseline assessment using all the scales mentioned above (with the exception of PDQ), before dignity therapy or standard palliative care (T1)
Day 7, 8 or 9: post-intervention assessment using all scales mentioned above (T2)
Day 15: assessment using HADS and ESAS (T3)
Day 30: assessment using HADS and ESAS (T4)

Overall trial start date

01/05/2010

Overall trial end date

01/05/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age ≥ 18 years old
2. Patient with a life-threatening disease
3. Patient able to read and speak Portuguese
4. Patient able to provide written informed consent
5. Patient with no evidence or diagnosis of dementia or delirium, demonstrated by information on medical chart or by clinical consensus between the main investigator and another palliative care physician
6. Mini Mental State score ≥ 20
7. Availability to have 4 to 5 research encounters, over a period of one month

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100 (50+50)

Participant exclusion criteria

Patients enrolled on other palliative care programs

Recruitment start date

01/05/2010

Recruitment end date

01/05/2013

Locations

Countries of recruitment

Portugal

Trial participating centre

Rua Pedro Hispano
Carnaxide
2790-250
Portugal

Sponsor information

Organisation

University of Lisbon (Portugal)

Sponsor details

c/o Prof. Egas Moniz
Faculty of Medicine
Lisbon
1649-028
Portugal
fml@fm.ul.pt

Sponsor type

University/education

Website

http://www.ul.pt/portal/page?_pageid=173,1&_dad=portal&_schema=PORTAL

Funders

Funder type

Other

Funder name

Investigator initiated and funded (Portugal)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes