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Implementation and Evaluation of Dignity Therapy in Denmark (DignityDK)

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ClinicalTrials.gov Identifier: NCT01507571
Recruitment Status : Completed
First Posted : January 11, 2012
Last Update Posted : January 11, 2012
Sponsor:
Information provided by (Responsible Party):
Mogens Groenvold, Bispebjerg Hospital

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.

Condition or disease Intervention/treatment Phase
Cancer Other: Dignity Therapy Phase 2

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  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Implementation and Evaluation of Dignity Therapy in Denmark
Study Start Date : September 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Arm Intervention/treatment
Experimental: Dignity Therapy Other: Dignity Therapy

Dignity Therapy is a brief psychotherapeutic intervention consisting of:

  1. a tape-recorded session with the patient using the DT question protocol
  2. Transcription of the interview, which is then edited
  3. 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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Hopelessness [ 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)

  2. Anxiety [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Measured on the Hospital anxiety and depression scale

  3. Depression [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Measured on the Hospital Anxiety and Depression scale

  4. Not able to perform tasks of daily living [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Measured on the Patient Dignity Inventory

  5. Suffering [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Measured with the Structured Interview for Symptoms and Concerns

  6. performance status [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Measured on the Palliative Performance Scale v2

  7. Communication [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Measured on the Structured Interview for Symptoms and Concerns

  8. Social Contact [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Measured on the Structured Interview for Symptoms and Concerns

  9. Depression [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Measured with the Structured Interview for Symptoms and Concerns

  10. Not able to attend to bodily functions [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  11. Physically distressing symptoms [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  12. Feeling how I look has changed [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  13. Feeling depressed [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  14. Feeling anxious [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  15. Feeling uncertain [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  16. Worried about future [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  17. Not able to think clearly [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  18. Not able to continue usual routines [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  19. Feeling no longer who I was [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  20. Not feeling worthwhile or valued [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  21. Not able to carry out important roles [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  22. Feeling life no longer has meaning or purpose [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  23. Feeling of not having made a meaningful contribution [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  24. Feeling of unfinished business [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  25. Concerns regarding spiritual life [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  26. Feeling like a burden to others [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  27. Feeling of not having control [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  28. Feeling of reduced privacy [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  29. Not feeling supported by friends or family [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  30. Not feeling supported by health care providers [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  31. Not feeling able to mentally fight illness [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  32. Not being able to accept things as they are [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  33. Not being treated with respect [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Item from the Patient Dignity Inventory

  34. Physical function [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Measured on the EORTC QLQ-C15-PAL

  35. Emotional function [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Measured on the EORTC QLQ-C15-PAL

  36. Overall quality of life [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Measured on the EORTC QLQ-C15-PAL

  37. Fatigue [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Measured on the EORTC QLQ-C15-PAL

  38. Nausea / Vomiting [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Measured on the EORTC QLQ-C15-PAL

  39. Pain [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Measured on the EORTC QLQ-C15-PAL

  40. Dyspnoea [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Measured on the EORTC QLQ-C15-PAL

  41. Insomnia [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Measured on the EORTC QLQ-C15-PAL

  42. Appetite loss [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Measured on the EORTC QLQ-C15-PAL

  43. Constipation [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ]
    Measured on the EORTC QLQ-C15-PAL



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507571


Locations
Denmark
Department of Palliative Medicine
Copenhagen, Denmark, 2400
Sankt Lukas Hospice
Hellerup, Denmark, 2900
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Principal Investigator: Mogens Groenvold, MD PhD DSci Bispebjerg Hospital/ Department of Public Health, Faculty of Health Sciences, University of Copenhagen

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mogens Groenvold, MD, PhD, D.M.Sci., Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01507571     History of Changes
Other Study ID Numbers: DignityTherapyDK 01
PP04011 ( Other Grant/Funding Number: Danish Cancer Society )
First Posted: January 11, 2012    Key Record Dates
Last Update Posted: January 11, 2012
Last Verified: January 2012

Keywords provided by Mogens Groenvold, Bispebjerg Hospital:
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