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Completed

NCT Number: NCT01507571

Implementation and Evaluation of Dignity Therapy in Denmark

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Palliative Medicine, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dignity Therapy

Other

Dignity Therapy is a brief psychotherapeutic intervention consisting of:

  • a tape-recorded session with the patient using the DT question protocol
  • Transcription of the interview, which is then edited
  • 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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Acronym: DignityDK

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jan 11, 2012
Registry last updated
Jan 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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