Implementation and Evaluation of Dignity Therapy in Denmark

Cancer Clinical Trial

— DignityDK  

Official title:

Implementation and Evaluation of Dignity Therapy in Denmark

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507571
• Other study ID #: DignityTherapyDK 01
• Secondary ID: PP04011
• Status: Completed
• Phase: Phase 2
• First received: November 11, 2011
• Last updated: January 10, 2012
• Start date: September 2005
• Est. completion date: September 2007

Study information

• Verified date: January 2012
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Dignity Therapy
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.

Locations

Country	Name	City	State
Denmark	Department of Palliative Medicine	Copenhagen
Denmark	Sankt Lukas Hospice	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Houmann LJ, Rydahl-Hansen S, Chochinov HM, Kristjanson LJ, Groenvold M. Testing the feasibility of the Dignity Therapy interview: adaptation for the Danish culture. BMC Palliat Care. 2010 Sep 22;9:21. doi: 10.1186/1472-684X-9-21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sense of dignity	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.	No
Secondary	Hopelessness	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.	No
Secondary	Anxiety	Measured on the Hospital anxiety and depression scale	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Depression	Measured on the Hospital Anxiety and Depression scale	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Not able to perform tasks of daily living	Measured on the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Suffering	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.	No
Secondary	performance status	Measured on the Palliative Performance Scale v2	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Communication	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.	No
Secondary	Social Contact	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.	No
Secondary	Depression	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.	No
Secondary	Not able to attend to bodily functions	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Physically distressing symptoms	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Feeling how I look has changed	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Feeling depressed	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Feeling anxious	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Feeling uncertain	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Worried about future	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Not able to think clearly	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Not able to continue usual routines	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Feeling no longer who I was	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Not feeling worthwhile or valued	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Not able to carry out important roles	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Feeling life no longer has meaning or purpose	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Feeling of not having made a meaningful contribution	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Feeling of unfinished business	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Concerns regarding spiritual life	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Feeling like a burden to others	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Feeling of not having control	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Feeling of reduced privacy	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Not feeling supported by friends or family	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Not feeling supported by health care providers	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Not feeling able to mentally fight illness	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Not being able to accept things as they are	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Not being treated with respect	Item from the Patient Dignity Inventory	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Physical function	Measured on the EORTC QLQ-C15-PAL	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Emotional function	Measured on the EORTC QLQ-C15-PAL	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Overall quality of life	Measured on the EORTC QLQ-C15-PAL	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Fatigue	Measured on the EORTC QLQ-C15-PAL	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Nausea / Vomiting	Measured on the EORTC QLQ-C15-PAL	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Pain	Measured on the EORTC QLQ-C15-PAL	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Dyspnoea	Measured on the EORTC QLQ-C15-PAL	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Insomnia	Measured on the EORTC QLQ-C15-PAL	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Appetite loss	Measured on the EORTC QLQ-C15-PAL	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No
Secondary	Constipation	Measured on the EORTC QLQ-C15-PAL	Pre-post intervention (when the document was received by the patient), and again two weeks later.	No