Clinical trial NCT01507571: Implementation and Evaluation of Dignity Therapy in Denmark
Official title: Implementation and Evaluation of Dignity Therapy in Denmark
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
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
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2012-01-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sense of dignity
timeFrame: Pre-post intervention (when the document was recieved by the patient), and again two weeks later.
Secondary outcomes:
measure: Hopelessness
timeFrame: Pre-post intervention (when the document was recieved by the patient), and again two weeks later.
measure: Anxiety
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Depression
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Not able to perform tasks of daily living
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Suffering
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: performance status
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Communication
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Social Contact
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Depression
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Not able to attend to bodily functions
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Physically distressing symptoms
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Feeling how I look has changed
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Feeling depressed
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Feeling anxious
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Feeling uncertain
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Worried about future
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Not able to think clearly
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Not able to continue usual routines
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Feeling no longer who I was
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Not feeling worthwhile or valued
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Not able to carry out important roles
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Feeling life no longer has meaning or purpose
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Feeling of not having made a meaningful contribution
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Feeling of unfinished business
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Concerns regarding spiritual life
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Feeling like a burden to others
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Feeling of not having control
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Feeling of reduced privacy
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Not feeling supported by friends or family
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Not feeling supported by health care providers
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Not feeling able to mentally fight illness
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Not being able to accept things as they are
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Not being treated with respect
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Physical function
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Emotional function
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Overall quality of life
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Fatigue
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Nausea / Vomiting
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Pain
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Dyspnoea
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Insomnia
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Appetite loss
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
measure: Constipation
timeFrame: Pre-post intervention (when the document was received by the patient), and again two weeks later.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Palliative Medicine
city: Hellerup
country: Denmark
facility: Sankt Lukas Hospice
Study officials:
affiliation: Bispebjerg Hospital/ Department of Public Health, Faculty of Health Sciences, University of Copenhagen
name: Mogens Groenvold, MD PhD DSci
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.