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Clinical Trial 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.


Clinical Trial 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 Design

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


Related Conditions & MeSH terms


NCT number NCT01507571
Study type Interventional
Source Bispebjerg Hospital
Contact
Status Completed
Phase Phase 2
Start date September 2005
Completion date September 2007

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