Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000800527
Ethics application status
Approved
Date submitted
15/06/2015
Date registered
31/07/2015
Date last updated
2/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Delivery of dignity therapy to people with limited life expectancy using e-health: A feasibility study
Scientific title
Delivery of dignity therapy to people with limited life expectancy using e-health: A feasibility study
Secondary ID [1] 286914 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End-of-life 295335 0
Condition category
Condition code
Cancer 295602 295602 0 0
Any cancer
Mental Health 295797 295797 0 0
Anxiety
Alternative and Complementary Medicine 295798 295798 0 0
Spiritual care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dignity Therapy is a brief, individualized psychotherapeutic intervention typically comprising of 4 to 6 one hour sessions where people with terminal illness are offered the opportunity to create a legacy document, the Dignity Therapy transcript. The number of sessions, frequency of sessions, and total number of sessions is flexible depending on the needs and desires of the participants.

In this study, Dignity Therapy will be offered using e-health methods, such as videoconferencing, email or chat. The method chosen will depend on the preferences of participants. The therapy will be administered by a psychotherapist trained and experienced in dignity therapy. Adherence to the intervention protocol will be monitored by three co-investigators trained in dignity therapy, who will review 20-30% of randomly selected interview transcripts. In this research, we will examine the feasibility, acceptability and potential effectiveness of dignity therapy delivered through e-health for equitable and cost-effective service delivery.
Intervention code [1] 292100 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295314 0
Participant Feedback Questionnaire, a validated questionnaire used in previous dignity therapy research
Timepoint [1] 295314 0
One week post treatment
Secondary outcome [1] 315338 0
Anxiety and Depression, as measured by the HADS (Hospital Anxiety & Depression Scale)
Timepoint [1] 315338 0
One week post treatment
Secondary outcome [2] 315339 0
Quality of Life in persons at end-of-life, as measured by the FACIT-PAL
Timepoint [2] 315339 0
One week post treatment
Secondary outcome [3] 315707 0
Hopefulness, as measured by the Herth Hope Index
Timepoint [3] 315707 0
One week post treatment

Eligibility
Key inclusion criteria
Persons diagnosed with a life-limiting condition with a prognosis of six months or less, but who are expected to survive 4 weeks or more.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Persons unable to communicate in English and/or provide informed consent due to cognitive issues or illness severity.

Persons who do not have access to a computer.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2015
Actual
1/04/2016
Date of last participant enrolment
Anticipated
11/01/2016
Actual
20/08/2016
Date of last data collection
Anticipated
Actual
4/01/2018
Sample size
Target
10
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 291473 0
University
Name [1] 291473 0
Murdoch University Small Grant Scheme
Country [1] 291473 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
Murdoch University
90 South Street
Murdoch
Western Australia 6150
Country
Australia
Secondary sponsor category [1] 290151 0
None
Name [1] 290151 0
Address [1] 290151 0
Country [1] 290151 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293021 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 293021 0
Murdoch University
90 South Street
Murdoch
Western Australia 6150
Ethics committee country [1] 293021 0
Australia
Date submitted for ethics approval [1] 293021 0
10/06/2015
Approval date [1] 293021 0
28/09/2015
Ethics approval number [1] 293021 0
2015/148

Summary
Brief summary
This study will examine the feasibility, acceptability and potential effectiveness of dignity therapy delivered through e-health methods for people with terminal illnesses. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with a life-limiting condition with a prognosis of six months or less, but are expected to survive 4 weeks or more. Study details All participants in this study will receive dignity therapy. Dignity therapy is an individualised end-of-life psychotherapy that aims to reduce distress and enhance quality of life for people with terminal illnesses and their families. Participants will receive 4 to 6 one hour sessions with a psychotherapist via e-health methods, such as videoconferencing, email or chat (depending on personal preference). Participants will be asked to complete some questionnaires one week post treatment in order to provide feedback and evaluate levels of anxiety and depression, quality of life and hopefulness.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58042 0
Dr Brenda Bentley
Address 58042 0
School of Health Professions
Murdoch University
90 South Street
Murdoch
Western Australia 6150
Country 58042 0
Australia
Phone 58042 0
+61 8 9360 2201
Fax 58042 0
Email 58042 0
[email protected]
Contact person for public queries
Name 58043 0
Dr Brenda Bentley
Address 58043 0
School of Health Professions
Murdoch University
90 South Street
Murdoch
Western Australia 6150
Country 58043 0
Australia
Phone 58043 0
+61 8 9360 2201
Fax 58043 0
Email 58043 0
[email protected]
Contact person for scientific queries
Name 58044 0
Dr Brenda Bentley
Address 58044 0
School of Health Professions
Murdoch University
90 South Street
Murdoch
Western Australia 6150
Country 58044 0
Australia
Phone 58044 0
+61 8 9360 2201
Fax 58044 0
Email 58044 0
[email protected]

No information has been provided regarding IPD availability


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.