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Trial registered on ANZCTR


Registration number
ACTRN12618000057280
Ethics application status
Approved
Date submitted
27/11/2017
Date registered
17/01/2018
Date last updated
23/01/2019
Date data sharing statement initially provided
23/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Dignity Therapy for people receiving palliative care.
Scientific title
Effect of Dignity Therapy as a psychotherapeutic intervention on distress in palliative care patients with cancer: A pilot randomised control trial
Secondary ID [1] 293454 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 305631 0
palliative care 305632 0
distress 305633 0
Condition category
Condition code
Cancer 304853 304853 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dignity therapy psychotherapeutic intervention. A clinician trained in dignity therapy will undertake a therapy session with participants.Iin this session the participant and therapist will sit down and engage in a discussion of the participants life guided by a standardised set of nine questions. The therapy will consist of two-to-three sessions, depending upon of the need for further discussion and editing of the document. The first session will be approximately 45 minutes - 1 hour long. The second session in which the therapist and participant actively and collaboratively edit the document will be approximately 20-30 minutes, and the third if needed will take no more than 15 minutes. Each session will be separate by approximately one week. Each will be conducted face-to-face. The therapist is a senior Cancer Care Coordinator who has trained with the founder of Dignity therapy, Dr Harvey Max Chochinov. The legacy document will be provided to participants approximately one to two weeks after completion of the intervention.
Intervention code [1] 299695 0
Treatment: Other
Comparator / control treatment
Standard palliative care provided by the service, including individualised, holistic care provided by the palliative care service, psychology, occupational therapy, social work, music therapy, scrapbooking, biography, and pastoral care.
Control group
Active

Outcomes
Primary outcome [1] 304053 0
Distress, measured with distress thermometer, patient dignity inventory
Timepoint [1] 304053 0
4 weeks post intervention.
Secondary outcome [1] 340805 0
Recruitment rate,
Timepoint [1] 340805 0
At provision of final document to participant which occurs one-two weeks after the final session
Secondary outcome [2] 341242 0
Withdrawal rate
Timepoint [2] 341242 0
Concluded on a case by case basis, and closed as each case is completed. For example if one participant withdraws before the completion of the therapy, that will be a withdrawal. If they complete the therapy and the document can be completed, that will be a completion.
Secondary outcome [3] 341243 0
Total time for intervention for each participant
Timepoint [3] 341243 0
Total time will include time spent in therapy sessions and time pent transcribing and preparing the document by the therapist.
Secondary outcome [4] 341244 0
Cost of intervention per participant calculated by the time spent on each case multiplied by the therapists hourly rate.
Timepoint [4] 341244 0
Calculated at the completion of each case

Eligibility
Key inclusion criteria
Cancer patients that have a palliative diagnosis and have been referred to the palliative care team will be eligible for inclusion.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants under 18 years of age, those not able to comprehend spoken and written English, patients with a cognitive impairment that would impact their ability to engage in the therapy, previous engagement in DT in another setting.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random computer sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As it is a pilot sample size is based upon funding availability. A data safety and monitoring committee will monitor data produced to assess effect size and sample size calculation as the trial proceeds.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2018
Actual
26/02/2018
Date of last participant enrolment
Anticipated
2/12/2019
Actual
Date of last data collection
Anticipated
2/01/2020
Actual
Sample size
Target
15
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9445 0
Mater Adult Hospital - South Brisbane
Recruitment postcode(s) [1] 18159 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 298079 0
Charities/Societies/Foundations
Name [1] 298079 0
Mater Foundation
Country [1] 298079 0
Australia
Primary sponsor type
Hospital
Name
Evidence in Practice Unit, Mater Misericordiae Limited.
Address
Level 2 Aubigny Place
Raymond Terrace
South Brisbane
QLD 4101
Country
Australia
Secondary sponsor category [1] 297158 0
None
Name [1] 297158 0
Address [1] 297158 0
Country [1] 297158 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299101 0
Mater Misericordiae Limitied Human Research Ethics Committee
Ethics committee address [1] 299101 0
Room 294, Level 2 Aubigny Place
Raymond Terrace
South Brisbane
QLD 4101
Ethics committee country [1] 299101 0
Australia
Date submitted for ethics approval [1] 299101 0
03/10/2017
Approval date [1] 299101 0
23/11/2017
Ethics approval number [1] 299101 0
HREC/17/MHS/110

Summary
Brief summary
This pilot study will determine the effects of dignity therapy for palliative care patients with cancer.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and are a cancer patient with a palliative diagnosis.

Study details
All participants in this trial will be randomly allocated (by chance) to receive either dignity therapy with a cancer care coordinator who is trained in dignity therapy or standard palliative care.

Participants will be followed-up at 4 weeks post intervention commencement with questionnaires to determine effect of treatment on levels of distress

We hope to provide evidence that may allow us to introduce Dignity Therapy into the routine care of our patients in Mater Cancer Care Centre.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79290 0
Mr Luke Burgess
Address 79290 0
Evidence in Practice Unit
Mater Misericordiae Limited
Level 2 Aubigny Place
Raymond Terrace
South Brisbane
QLD 4101
Country 79290 0
Australia
Phone 79290 0
+61 0731638782
Fax 79290 0
Email 79290 0
luke.burgess@mater.org.au
Contact person for public queries
Name 79291 0
Mr Luke Burgess
Address 79291 0
Evidence in Practice Unit
Mater Misericordiae Limited
Level 2 Aubigny Place
Raymond Terrace
South Brisbane
QLD 4101
Country 79291 0
Australia
Phone 79291 0
+61 7 31638782
Fax 79291 0
Email 79291 0
luke.burgess@mater.org.au
Contact person for scientific queries
Name 79292 0
Mr Luke Burgess
Address 79292 0
Evidence in Practice Unit
Mater Misericordiae Limited
Level 2 Aubigny Place
Raymond Terrace
South Brisbane
QLD 4101
Country 79292 0
Australia
Phone 79292 0
+61 7 3163 8782
Fax 79292 0
Email 79292 0
luke.burgess@mater.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.