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Implementation and Evaluation of Dignity Therapy in Denmark

Phase 2
Completed
Conditions
Cancer
Interventions
Other: Dignity Therapy
Registration Number
NCT01507571
Lead Sponsor
Bispebjerg Hospital
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Dignity TherapyDignity Therapy-
Primary Outcome Measures
NameTimeMethod
Sense of dignityPre-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 Outcome Measures
NameTimeMethod
HopelessnessPre-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)

AnxietyPre-post intervention (when the document was received by the patient), and again two weeks later.

Measured on the Hospital anxiety and depression scale

DepressionPre-post intervention (when the document was received by the patient), and again two weeks later.

Measured with the Structured Interview for Symptoms and Concerns

Not able to perform tasks of daily livingPre-post intervention (when the document was received by the patient), and again two weeks later.

Measured on the Patient Dignity Inventory

SufferingPre-post intervention (when the document was received by the patient), and again two weeks later.

Measured with the Structured Interview for Symptoms and Concerns

performance statusPre-post intervention (when the document was received by the patient), and again two weeks later.

Measured on the Palliative Performance Scale v2

CommunicationPre-post intervention (when the document was received by the patient), and again two weeks later.

Measured on the Structured Interview for Symptoms and Concerns

Social ContactPre-post intervention (when the document was received by the patient), and again two weeks later.

Measured on the Structured Interview for Symptoms and Concerns

Not able to attend to bodily functionsPre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Physically distressing symptomsPre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Feeling how I look has changedPre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

PainPre-post intervention (when the document was received by the patient), and again two weeks later.

Measured on the EORTC QLQ-C15-PAL

Feeling depressedPre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Feeling anxiousPre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Feeling uncertainPre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Worried about futurePre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Not able to think clearlyPre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Not able to continue usual routinesPre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Feeling no longer who I wasPre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Not feeling worthwhile or valuedPre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Not able to carry out important rolesPre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Feeling life no longer has meaning or purposePre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Feeling of not having made a meaningful contributionPre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Feeling of unfinished businessPre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Concerns regarding spiritual lifePre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Feeling like a burden to othersPre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Feeling of not having controlPre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Feeling of reduced privacyPre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Not feeling supported by friends or familyPre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Not feeling supported by health care providersPre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Not feeling able to mentally fight illnessPre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Not being able to accept things as they arePre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Not being treated with respectPre-post intervention (when the document was received by the patient), and again two weeks later.

Item from the Patient Dignity Inventory

Physical functionPre-post intervention (when the document was received by the patient), and again two weeks later.

Measured on the EORTC QLQ-C15-PAL

Emotional functionPre-post intervention (when the document was received by the patient), and again two weeks later.

Measured on the EORTC QLQ-C15-PAL

Overall quality of lifePre-post intervention (when the document was received by the patient), and again two weeks later.

Measured on the EORTC QLQ-C15-PAL

FatiguePre-post intervention (when the document was received by the patient), and again two weeks later.

Measured on the EORTC QLQ-C15-PAL

Nausea / VomitingPre-post intervention (when the document was received by the patient), and again two weeks later.

Measured on the EORTC QLQ-C15-PAL

DyspnoeaPre-post intervention (when the document was received by the patient), and again two weeks later.

Measured on the EORTC QLQ-C15-PAL

InsomniaPre-post intervention (when the document was received by the patient), and again two weeks later.

Measured on the EORTC QLQ-C15-PAL

Appetite lossPre-post intervention (when the document was received by the patient), and again two weeks later.

Measured on the EORTC QLQ-C15-PAL

ConstipationPre-post intervention (when the document was received by the patient), and again two weeks later.

Measured on the EORTC QLQ-C15-PAL

Trial Locations

Locations (2)

Sankt Lukas Hospice

🇩🇰

Hellerup, Denmark

Department of Palliative Medicine

🇩🇰

Copenhagen, Denmark

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