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Implementation and Evaluation of Dignity Therapy in Denmark


Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

Implementation and Evaluation of Dignity Therapy in Denmark


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Sense of dignity

Outcome Description:

Measured with the Structured Interview for Symptoms and Concerns (SISC)

Outcome Time Frame:

Pre-post intervention (when the document was recieved by the patient), and again two weeks later.

Safety Issue:

No

Principal Investigator

Mogens Groenvold, MD PhD DSci

Investigator Role:

Principal Investigator

Investigator Affiliation:

Bispebjerg Hospital/ Department of Public Health, Faculty of Health Sciences, University of Copenhagen

Authority:

Denmark: The Regional Committee on Biomedical Research Ethics

Study ID:

DignityTherapyDK 01

NCT ID:

NCT01507571

Start Date:

September 2005

Completion Date:

September 2007

Related Keywords:

  • Cancer
  • 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

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