Implementation and Evaluation of Dignity Therapy in Denmark (DignityDK)

January 10, 2012 updated by: Mogens Groenvold, Bispebjerg Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Department of Palliative Medicine
      • Hellerup, Denmark, 2900
        • Sankt Lukas Hospice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Pre-post intervention (when the document was recieved by the patient), and again two weeks later.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Pre-post intervention (when the document was recieved by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.
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
Pre-post intervention (when the document was received by the patient), and again two weeks later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bispebjerg Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mogens Groenvold, MD PhD DSci, Bispebjerg Hospital/ Department of Public Health, Faculty of Health Sciences, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DignityTherapyDK 01
  • PP04011 (Other Grant/Funding Number: Danish Cancer Society)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Clinical Trials on Dignity Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings