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Implementation and Evaluation of Dignity Therapy in Denmark (DignityDK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mogens Groenvold, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01507571
First received: November 11, 2011
Last updated: January 10, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Cancer
Other: Dignity Therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Implementation and Evaluation of Dignity Therapy in Denmark

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Sense of dignity [ Time Frame: Pre-post intervention (when the document was recieved by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Measured with the Structured Interview for Symptoms and Concerns (SISC)


Secondary Outcome Measures:
  • Hopelessness [ Time Frame: Pre-post intervention (when the document was recieved by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Measured with the Structured Interview for Symptoms and Concerns (SISC)

  • Anxiety [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Measured on the Hospital anxiety and depression scale

  • Depression [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Measured on the Hospital Anxiety and Depression scale

  • 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. ] [ Designated as safety issue: No ]
    Measured on the Patient Dignity Inventory

  • Suffering [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Measured with the Structured Interview for Symptoms and Concerns

  • performance status [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Measured on the Palliative Performance Scale v2

  • Communication [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Measured on the Structured Interview for Symptoms and Concerns

  • Social Contact [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Measured on the Structured Interview for Symptoms and Concerns

  • Depression [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Measured with the Structured Interview for Symptoms and Concerns

  • 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. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • Physically distressing symptoms [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • Feeling how I look has changed [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • Feeling depressed [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • Feeling anxious [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • Feeling uncertain [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • Worried about future [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • Not able to think clearly [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • Not able to continue usual routines [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

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

  • Not feeling worthwhile or valued [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • 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. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • 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. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • 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. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • Feeling of unfinished business [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • Concerns regarding spiritual life [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • Feeling like a burden to others [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • Feeling of not having control [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • Feeling of reduced privacy [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • 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. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • 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. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • 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. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • 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. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • Not being treated with respect [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Item from the Patient Dignity Inventory

  • Physical function [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Measured on the EORTC QLQ-C15-PAL

  • Emotional function [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Measured on the EORTC QLQ-C15-PAL

  • Overall quality of life [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Measured on the EORTC QLQ-C15-PAL

  • Fatigue [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Measured on the EORTC QLQ-C15-PAL

  • Nausea / Vomiting [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Measured on the EORTC QLQ-C15-PAL

  • Pain [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Measured on the EORTC QLQ-C15-PAL

  • Dyspnoea [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Measured on the EORTC QLQ-C15-PAL

  • Insomnia [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Measured on the EORTC QLQ-C15-PAL

  • Appetite loss [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Measured on the EORTC QLQ-C15-PAL

  • Constipation [ Time Frame: Pre-post intervention (when the document was received by the patient), and again two weeks later. ] [ Designated as safety issue: No ]
    Measured on the EORTC QLQ-C15-PAL


Enrollment: 80
Study Start Date: September 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
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
Study First Received: November 11, 2011
Last Updated: January 10, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by 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
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014