Implementation and Evaluation of Dignity Therapy in Denmark (DignityDK)

The purpose of the study is to investigate whether Danish patients with incurable cancer have a need of, interest in and benefit from Dignity Therapy.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Dignity Therapy

Detailed Description

Research in palliative care has primarily focused on physical and psychological symptoms. Research in other psychosocial and existential problems has been sparse. Loss of dignity as a consequence of serious illness may be an important cause of suffering. The research team of the Canadian psychiatrist and professor, Harvey Chochinov has investigated the concept of dignity and developed the psychosocial intervention 'Dignity Therapy' (DT). The preliminary research results were promising.

Research questions: Do Danish cancer patients have a need of, interest in, and benefit from DT? Methods: DT consists of an interview revolving around the patient's life, values, and accomplishments and is also an opportunity to leave messages and words of hope and compassion for friends and family. The interview is audio taped, transcribed, and edited together with the patient, and made into a tangible document, which the patient can give to his/her relatives. The project consists of three parts: (1) a cross-sectional investigation of the prevalence of loss of dignity and related symptoms/problems among at least 200 incurable cancer patients. (2) A feasibility study, testing the intervention in terms of relevance and the need of any modifications in relation to Danish patients. (3) An evaluation study testing the effect of and satisfaction with DT.

At least 80 patients are planned for the feasibility and evaluation studies. Questionnaires are used for detection of loss of dignity and as measures of effect. These will be administered before the intervention and, along with a semi-structured evaluation questionnaire, right after the intervention, when the document is received and again approximately two weeks later.

The duration of the intervention (DT) varies markedly between patients. In some cases the process (interview, transcription, editing of document, and the final meeting where the document is given back to the patient) is completed urgently in a few days, whereas in other cases, the patient prefers a slower pace, and may want to sub-divide the interview into two or more parts. Also, when presented with the document, some patients want to have something changed or they want add material. This variation is seen as intentional, as it illustrates that the process is tailored to the patient's wishes.

As stated, the effect of the DT intervention is evaluated at completion of the intervention, i.e. when the final document is given back to the patient, and about two weeks later. Due to process described above, the time from the first measurement (before intervention) to the second measurement (which takes places at completion of the intervention) therefore varies considerably (median 36 days after baseline, range 7-121 days).

Perspective: If Danish patients have a need of, an interest in and benefit from DT, it can be offered to Danish patients admitted to palliative care.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Department of Palliative Medicine
  • Hellerup, Denmark, 2900
    • Sankt Lukas Hospice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnosis of incurable cancer,
• 18 years or older,
• informed of diagnosis and the incurable prognosis.

Exclusion Criteria:

• dementia and other cognitive impairment,
• physical limitations,
• sufficient to preclude participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Dignity Therapy

Other: Dignity Therapy; Dignity Therapy is a brief psychotherapeutic intervention consisting of: a tape-recorded session with the patient using the DT question protocol; Transcription of the interview, which is then edited; A session where the edited transcript is returned to the patient who can give it to family members or friends. If needed, one or more sessions are added. Dt allows the patient to give voice to the matters of importance concerning himself and his loved ones. Its purpose is to enhance sense of meaning, purpose and worth. It also gives the opportunity to leave something behind to be remembered by.; Other Names: Psychotherapeutic intervention; Psychosocial intervention; End of life care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sense of dignity	Measured with the Structured Interview for Symptoms and Concerns (SISC)	Pre-post intervention (when the document was recieved by the patient), and again two weeks later.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hopelessness	Measured with the Structured Interview for Symptoms and Concerns (SISC)	Pre-post intervention (when the document was recieved by the patient), and again two weeks later.
Anxiety	Measured on the Hospital anxiety and depression scale	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Depression	Measured on the Hospital Anxiety and Depression scale	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not able to perform tasks of daily living	Measured on the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Suffering	Measured with the Structured Interview for Symptoms and Concerns	Pre-post intervention (when the document was received by the patient), and again two weeks later.
performance status	Measured on the Palliative Performance Scale v2	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Communication	Measured on the Structured Interview for Symptoms and Concerns	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Social Contact	Measured on the Structured Interview for Symptoms and Concerns	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Depression	Measured with the Structured Interview for Symptoms and Concerns	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not able to attend to bodily functions	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Physically distressing symptoms	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling how I look has changed	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling depressed	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling anxious	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling uncertain	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Worried about future	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not able to think clearly	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not able to continue usual routines	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling no longer who I was	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not feeling worthwhile or valued	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not able to carry out important roles	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling life no longer has meaning or purpose	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling of not having made a meaningful contribution	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling of unfinished business	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Concerns regarding spiritual life	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling like a burden to others	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling of not having control	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Feeling of reduced privacy	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not feeling supported by friends or family	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not feeling supported by health care providers	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not feeling able to mentally fight illness	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not being able to accept things as they are	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Not being treated with respect	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Physical function	Measured on the EORTC QLQ-C15-PAL	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Emotional function	Measured on the EORTC QLQ-C15-PAL	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Overall quality of life	Measured on the EORTC QLQ-C15-PAL	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Fatigue	Measured on the EORTC QLQ-C15-PAL	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Nausea / Vomiting	Measured on the EORTC QLQ-C15-PAL	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Pain	Measured on the EORTC QLQ-C15-PAL	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Dyspnoea	Measured on the EORTC QLQ-C15-PAL	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Insomnia	Measured on the EORTC QLQ-C15-PAL	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Appetite loss	Measured on the EORTC QLQ-C15-PAL	Pre-post intervention (when the document was received by the patient), and again two weeks later.
Constipation	Measured on the EORTC QLQ-C15-PAL	Pre-post intervention (when the document was received by the patient), and again two weeks later.

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Investigators: Principal Investigator: Mogens Groenvold, MD PhD DSci, Bispebjerg Hospital/ Department of Public Health, Faculty of Health Sciences, University of Copenhagen

Publications and helpful links

General Publications

• Houmann LJ, Rydahl-Hansen S, Chochinov HM, Kristjanson LJ, Groenvold M. Testing the feasibility of the Dignity Therapy interview: adaptation for the Danish culture. BMC Palliat Care. 2010 Sep 22;9:21. doi: 10.1186/1472-684X-9-21.
• Houmann LJ, Chochinov HM, Kristjanson LJ, Petersen MA, Groenvold M. A prospective evaluation of Dignity Therapy in advanced cancer patients admitted to palliative care. Palliat Med. 2014 May;28(5):448-58. doi: 10.1177/0269216313514883. Epub 2013 Dec 5.

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: November 11, 2011
• First Submitted That Met QC Criteria: January 10, 2012
• First Posted (Estimate): January 11, 2012

Study Record Updates

• Last Update Posted (Estimate): January 11, 2012
• Last Update Submitted That Met QC Criteria: January 10, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Incurable cancer; Palliative care; Dignity Therapy; Loss of dignity; Patient Dignity Intventory; Eortc QLQ-C15-PAL; Structured Interview for Symptoms and Concerns; Hospital Anxiety and Depression Scale
• Additional Relevant MeSH Terms: Psychotropic Drugs
• Other Study ID Numbers: DignityTherapyDK 01; PP04011 (Other Grant/Funding Number: Danish Cancer Society)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No