Implementation and Evaluation of Dignity Therapy in Denmark
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Bispebjerg Hospital
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Sense of dignity
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Dignity Therapy
Intervention: Dignity Therapy (Other)
Outcomes
Primary Outcomes
Sense of dignity
Time Frame: Pre-post intervention (when the document was recieved by the patient), and again two weeks later.
Measured with the Structured Interview for Symptoms and Concerns (SISC)
Secondary Outcomes
- Depression(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Hopelessness(Pre-post intervention (when the document was recieved by the patient), and again two weeks later.)
- Anxiety(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Not able to perform tasks of daily living(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Suffering(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- performance status(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Communication(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Social Contact(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Not able to attend to bodily functions(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Physically distressing symptoms(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Feeling how I look has changed(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Feeling depressed(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Feeling anxious(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Feeling uncertain(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Worried about future(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Not able to think clearly(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Not able to continue usual routines(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Feeling no longer who I was(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Not feeling worthwhile or valued(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Not able to carry out important roles(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Feeling life no longer has meaning or purpose(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Feeling of not having made a meaningful contribution(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Feeling of unfinished business(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Concerns regarding spiritual life(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Feeling like a burden to others(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Feeling of not having control(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Feeling of reduced privacy(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Not feeling supported by friends or family(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Not feeling supported by health care providers(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Not feeling able to mentally fight illness(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(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Not being treated with respect(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Physical function(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Emotional function(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Overall quality of life(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Fatigue(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Nausea / Vomiting(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Pain(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Dyspnoea(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Insomnia(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Appetite loss(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
- Constipation(Pre-post intervention (when the document was received by the patient), and again two weeks later.)
Investigators
Mogens Groenvold
MD, PhD, D.M.Sci.
Bispebjerg Hospital