Implementation and Evaluation of Dignity Therapy in Denmark

NCT ID: NCT01507571

Last Updated: 2012-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2007-09-30

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.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Dignity Therapy

Group Type: EXPERIMENTAL

Dignity Therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Psychotherapeutic intervention; Psychosocial intervention; End of life care

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mogens Groenvold

MD, PhD, D.M.Sci.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mogens Groenvold, MD PhD DSci

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital/ Department of Public Health, Faculty of Health Sciences, University of Copenhagen

Locations

Department of Palliative Medicine

Copenhagen, , Denmark

Sankt Lukas Hospice

Hellerup, , Denmark

Countries

Denmark

References

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.

Reference Type: RESULT

PMID: 20860786 (View on PubMed)

Houmann LJ, Chochinov HM, Kristjanson LJ, Petersen MA, Groenvold M. A prospective evaluation of Dignity Therapy in advanced cancer patients admitted to palliative care. Palliat Med. 2014 May;28(5):448-58. doi: 10.1177/0269216313514883. Epub 2013 Dec 5.

Reference Type: DERIVED

PMID: 24311296 (View on PubMed)

Other Identifiers

PP04011

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

DignityTherapyDK 01

Identifier Type: -

Identifier Source: org_study_id