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Trial registered on ANZCTR


Registration number
ACTRN12611000584932
Ethics application status
Approved
Date submitted
26/05/2011
Date registered
7/06/2011
Date last updated
22/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Dignity Therapy and Life Review for Inpatients and Outpatients with Advanced Cancer
Scientific title
The effect of dignity therapy versus life review and waitlist control on sense of dignity, distress and quality of life in advanced cancer and palliative patients
Secondary ID [1] 262237 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 267932 0
Condition category
Condition code
Cancer 268078 268078 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dignity Therapy

Dignity Therapy is a brief individualized psychological therapy specifically intended for terminally ill patients (Chochinov et al., 2004). It provides patients with an opportunity to create a legacy document that includes aspects of their life that they see as important or meaningful, personal history that they would want others to know, words of wisdom, personal values, hopes and dreams for their loved ones and things that need to be said to their loved ones. Patients are guided through protocol questions, and the legacy document is created when a clinician records, transcribes, edits, and presents back the transcription of the session/s back to the patient who can then choose who they would give the legacy document to. It is a relatively brief intervention in that it typically takes one to three 45-minute sessions face-to-face with patient and additional time to transcribe the sessions, make edits and present the legacy document.
Intervention code [1] 266626 0
Treatment: Other
Comparator / control treatment
1. Waitlist Control
2. Life Review

Participants in the Waitlist Control Group will be offered Dignity Therapy after a waiting period of one week. This waiting period is population-specific in that it will allow for better control of potential inflated benefits of intervention groups that could occur due to patient deterioration. They will complete assessment measures at three times: (1) at beginning of waiting period, (2) prior to Dignity Therapy, and (3) after Dignity Therapy.

Life Review also involves face-to-face discussion about past life experiences, important achievements, personal values and hopes and dreams for loved ones. This process is expected to take one to three 45-minute sessions. Key difference between Life Review and Dignity Therapy is that Life Review does not involve creation of a legacy document.
Control group
Active

Outcomes
Primary outcome [1] 266826 0
Sense of Dignity. This is measured by the Patient Dignity Inventory, which is a reliable and valid 25-item measure of dignity-related distress that is based on the Dignity Model (Chochinov et al., 2008)
Timepoint [1] 266826 0
Pre-test
Pre-test 2 (Waitlist Control group - seven days after pre-test)
Post-test (three days after Dignity Therapy or Life Review)
Primary outcome [2] 266827 0
Sense of Generativity and Ego Integrity. This is measured by the Generativity and Ego-Integrity Questionnaire that was purpose-developed and piloted specifically for this study. This measure has 11 items.

Based on Erikson's theory of psychosocial development, Generativity refers to a person's concern for the next generation, for passing skills and knowledge to others, for being productive, and for leaving a lasting legacy. Ego Integrity refers to looking back on one's life with a sense of meaning, acceptance of past life events, and the absence of death anxiety.
Timepoint [2] 266827 0
Pre-test
Pre-test 2 (Waitlist Control group - seven days after pre-test)
Post-test (three days after Dignity Therapy or Life Review)
Primary outcome [3] 266828 0
Perceived Quality of Life. This is measured by the Functional Assessment of Cancer Therapy-General, version 4 (FACT-G)

The FACT-G is a core questionnaire in the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. FACIT is a collection of quality of life questionnaires targeted to the management of chronic illness and it also includes supplemental measures targeted towards specific diseases, conditions or treatments. The FACT-G contains 27 items divided into four primary quality of life domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The FACT-G has established psychometric properties with good reliability and validity and it is appropriate for use with patients with all forms of cancer and other chronic illness conditions (Overcash et al., 2001; Webster, Cella & Yost, 2003; Webster et al., 1999).
Timepoint [3] 266828 0
Pre-test
Pre-test 2 (Waitlist Control group - seven days after pre-test)
Post-test (three days after Dignity Therapy or Life Review)
Secondary outcome [1] 276463 0
Clinician-rated functional ability and phase of illness as measured by the Palliative Care Phase Instrument (PCPI).

PCPI categorises a patient into one of five phases of illness (1 = stable, 2 = unstable, 3 = deteriorating, 4 = terminal, 5 = bereaved).
Timepoint [1] 276463 0
Pre-test
Pre-test 2 (Waitlist Control group - seven days after pre-test)
Post-test (three days after Dignity Therapy or Life Review)
Secondary outcome [2] 276464 0
Clinician-rated functional ability and phase of illness as measured Karnofsky Performance Scale (KPS).

KPS is a measure of patients' overall function or ability to perform activities of daily living on a scale from 0 to 100 (100 = Normal, no complaints, no evidence of disease, 0 = Dead).
Timepoint [2] 276464 0
Pre-test
Pre-test 2 (Waitlist Control group - seven days after pre-test)
Post-test (three days after Dignity Therapy or Life Review)
Secondary outcome [3] 276465 0
Clinician-rated functional ability and phase of illness as measured by Resource Utilization Groups - Activities of Daily Living (RUG-ADL).

RUG-ADL is a measure of patients' assistance requirements for eating, bed mobility, toileting and transfer.
Timepoint [3] 276465 0
Pre-test
Pre-test 2 (Waitlist Control group - seven days after pre-test)
Post-test (three days after Dignity Therapy or Life Review)

Eligibility
Key inclusion criteria
1. Diagnosis of advanced cancer with life expectancy of less than 12 months (clinical consensus)
2. Minimum age of 18 years
3. English speaking
4. Commitment to up to four contacts over approximately 7 to 10 days
5. No cognitive impairment (clinical consensus)
6. Willingness to provide verbal and written consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. To reduce potential bias, patients previously followed by primary investigator who also works as a psychologist in cancer services and palliative care will be excluded from this study
2. Significant cognitive impairment (clinical consensus and/or scores on cognitive screening tools)

Patients with advanced non-cancer illnesses will not be excluded from the study but due to setting of this study it is highly unlikely that a significant number will be recruited.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly assigned to one of three groups: Dignity Therapy Group (DT), Life Review Group (LR) or Waitlist Control Group (WC). Group allocation will be performed by block randomization in order to ensure a balance in sample size across treatment groups over time. Allocation concealment will be facilitated by using sequentially numbered sealed envelopes for consecutive eligible participants. To reduce the risk of bias, envelopes will be opened to ascertain group allocation after pre-test measures have been administered.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Altman and Bland (1999) recommended use of block sizes that are a multiple of the number of groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 4047 0
4215

Funding & Sponsors
Funding source category [1] 267135 0
University
Name [1] 267135 0
Griffith University (School of Psychology, Gold Coast Campus)
Address [1] 267135 0
Parklands Drive
Southport, QLD
4215
Country [1] 267135 0
Australia
Primary sponsor type
Individual
Name
Dean Vuksanovic
Address
Allied Health Offices (D Block)
Gold Coast University Hospital
Southport, QLD, 4215
Country
Australia
Secondary sponsor category [1] 264211 0
Individual
Name [1] 264211 0
Prof Murray Dyck
Address [1] 264211 0
School of Psychology
Griffith University
Parklands Drive
Southport, QLD
4215
Country [1] 264211 0
Australia
Secondary sponsor category [2] 264212 0
Individual
Name [2] 264212 0
Dr Heather Green
Address [2] 264212 0
School of Psychology
Griffith University
Parklands Drive
Southport, QLD
4215
Country [2] 264212 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269130 0
Gold Coast Health Service District HREC
Ethics committee address [1] 269130 0
Gold Coast University Hospital
1 Hospital Boulevard
Southport, QLD, 4215
Ethics committee country [1] 269130 0
Date submitted for ethics approval [1] 269130 0
01/07/2011
Approval date [1] 269130 0
20/01/2012
Ethics approval number [1] 269130 0
HREC/11/QGC/83

Summary
Brief summary
This study aims to evaluate the effectiveness of a new intervention called Dignity Therapy in patients with advanced cancer and patients receiving palliative care. Effects on sense of dignity, distress and quality of life will be investigated.

Who is it for?
You can join this study if: (a) you have a diagnosis of advanced cancer with life expectancy of 12 months or less, (b) you have no significant cognitive impairment, (c) you are at least 18 years of age, and (d) have at least basic fluency in English language.

Trial Details:
Dignity Therapy aims to strengthen a person’s sense of worth, meaning and purpose by allowing people to create a lasting legacy document for their loved ones. A legacy document can include information about a person’s life that they see as important or meaningful, personal history that they would want others to know about, words of wisdom and life lessons, personal values, hopes and dreams for their loved ones, words of advice and things that need to be said or repeated to their loved ones. A legacy document is created when an audio recording of this discussion is transcribed and given back to participants to make any necessary changes. Additions to legacy documents can also be made at this time. A final legacy document is given back to participants in paper form and a digital copy is also included on an archival CD. Although initial evaluations of Dignity Therapy in Western Australia, Canada and the United Kingdom have yielded positive results for both participants and their families, further research is required before conclusions can be made about effectiveness of Dignity Therapy.

This study also aims to evaluate a similar intervention called Life Review. This intervention also involves discussion about past life experiences, important achievements, personal values and hopes and dreams for loved ones. However, Life Review is different to Dignity Therapy in that it does not involve creation of a legacy document. This discussion also needs to be recorded in order to make sure that the two interventions were delivered in an identical way. Direct comparison of these two interventions has never been done before. This will allow for specific conclusions to be made about their effectiveness in helping patients with advanced illnesses and their families.

Participants in this trial will be randomly (by chance) assigned to one of three groups. One group will receive Dignity Therapy, second group will undergo Life Review and third group will receive standard care for 1 week and then undergo Dignity Therapy. Participants will be asked to complete questionnaires before and after treatment to assess their sense of dignity, distress and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32648 0
Mr Dean Vuksanovic
Address 32648 0
Allied Health Offices (D Block)
Gold Coast University Hospital
1 Hospital Boulevard
Southport, QLD, 4215
Country 32648 0
Australia
Phone 32648 0
+61, 07, 56873134
Fax 32648 0
Email 32648 0
Dean.vuksanovic@health.qld.gov.au
Contact person for public queries
Name 15895 0
Mr Dean Vuksanovic
Address 15895 0
Allied Health Offices (D Block)
Gold Coast University Hospital
1 Hospital Boulevard
Southport, QLD, 4215
Country 15895 0
Australia
Phone 15895 0
+61, 07, 56873134
Fax 15895 0
Email 15895 0
Dean.vuksanovic@health.qld.gov.au
Contact person for scientific queries
Name 6823 0
Mr Dean Vuksanovic
Address 6823 0
Allied Health Offices (D Block)
Gold Coast University Hospital
1 Hospital Boulevard
Southport, QLD, 4215
Country 6823 0
Australia
Phone 6823 0
+61, 07, 56873134
Fax 6823 0
Email 6823 0
Dean.vuksanovic@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary