NCT01507571

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2 cancer

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 11, 2012

Completed
Last Updated

January 11, 2012

Status Verified

January 1, 2012

Enrollment Period

2 years

First QC Date

November 11, 2011

Last Update Submit

January 10, 2012

Conditions

Cancer

Keywords

Incurable cancerPalliative careDignity TherapyLoss of dignityPatient Dignity IntventoryEortc QLQ-C15-PALStructured Interview for Symptoms and ConcernsHospital Anxiety and Depression Scale

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (43)

  • Hopelessness

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

  • Anxiety

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

  • Depression

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

  • Not able to perform tasks of daily living

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

  • Suffering

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

  • +38 more secondary outcomes

Study Arms (1)

Dignity Therapy

EXPERIMENTAL
Other: Dignity Therapy

Interventions

Dignity TherapyOTHER

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.

Also known as: Psychotherapeutic intervention, Psychosocial intervention, End of life care
Dignity Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of incurable cancer,
  • years or older,
  • informed of diagnosis and the incurable prognosis.

You may not qualify if:

  • dementia and other cognitive impairment,
  • physical limitations,
  • sufficient to preclude participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Palliative Medicine

Copenhagen, 2400, Denmark

Location

Sankt Lukas Hospice

Hellerup, 2900, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 20860786RESULT

  • 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.

    PMID: 24311296DERIVED

MeSH Terms

Conditions

NeoplasmsDepression

Interventions

Dignity TherapyPsychosocial InterventionTerminal Care

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mogens Groenvold, MD PhD DSci

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, D.M.Sci.

Study Record Dates

First Submitted

November 11, 2011

First Posted

January 11, 2012

Study Start

September 1, 2005

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

January 11, 2012

Record last verified: 2012-01

Locations

DK(2)