Implementation and Evaluation of Dignity Therapy in Denmark

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Implementation and Evaluation of Dignity Therapy in Denmark

Conditions
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Cancer

Intervention / Treatment
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* Other: Dignity Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dignity Therapy<br> | Other: Dignity Therapy<br>* 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.<br>* Other names: End of life care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| Feeling depressed | Item from the Patient Dignity Inventory | Pre-post intervention (when the document was received by the patient), and again two weeks later. | 
| Feeling anxious | Item from the Patient Dignity Inventory | Pre-post intervention (when the document was received by the patient), and again two weeks later. | 
| Feeling uncertain | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Item from the Patient Dignity Inventory | Pre-post intervention (when the document was received by the patient), and again two weeks later. | 
| 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. | 
| 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. | 
| 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. | 
| Fatigue | 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 | Measured on the EORTC QLQ-C15-PAL | Pre-post intervention (when the document was received by the patient), and again two weeks later. | 
| Pain | Measured on the EORTC QLQ-C15-PAL | Pre-post intervention (when the document was received by the patient), and again two weeks later. | 
| Dyspnoea | Measured on the EORTC QLQ-C15-PAL | Pre-post intervention (when the document was received by the patient), and again two weeks later. | 
| Insomnia | 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 | Measured on the EORTC QLQ-C15-PAL | Pre-post intervention (when the document was received by the patient), and again two weeks later. | 
| Constipation | Measured on the EORTC QLQ-C15-PAL | Pre-post intervention (when the document was received by the patient), and again two weeks later. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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