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Trial registered on ANZCTR


Registration number
ACTRN12615001333505
Ethics application status
Approved
Date submitted
2/12/2015
Date registered
7/12/2015
Date last updated
9/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the acceptability and feasibility of a program to assist people diagnosed with cancer to talk about and plan for future medical care
Scientific title
A pilot randomised controlled trial testing the acceptability and feasibility of an intervention to assist people diagnosed with with cancer to discuss and document wishes for future medical care
Secondary ID [1] 287821 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 296699 0
Condition category
Condition code
Cancer 296936 296936 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Advance care planning (ACP) involves a person discussing with their treatment team and family the medical care they would prefer in case they became too ill in the future to express their wishes, documenting their wishes in a written statement and/or appointing a substitute-decision maker. Patients randomised to the intervention will receive the following three strategies at study recruitment designed to increase engagement in ACP:
(1) Provision of a prescriptive letter. Participants will receive a letter at the appointment informing them of the importance of undertaking ACP, The letter will emphasise that the oncologist provides advice to all their patients to plan for their future medical care, regardless of diagnosis or prognosis. The letter will include: (i) an explanation of the purpose and importance of future planning; (ii) state-specific information about enduring guardianship and advance directives, including their purpose and benefits.
(2) Use of Start2Talk and/or DVD. Participants will be encouraged to access the Start2Talk website to facilitate documentation of an advance care plan (http://www.start2talk.org.au/); and/or watch the DVD of a practicing clinician explaining advance care planning to a simulated patient. Patients will be encouraged to complete the provided worksheets to document an advance care plan. In particular they will be encouraged to complete Worksheets 1.4 and 1.5, which involve completing a statement of values and wishes and a more specific directive.
(3) SMS prompts. Participants will receive an SMS prompt from the research team 2 weeks and 4 weeks after recruitment reminding them to access the Start2Talk website and/or watch the DVD. The SMS message will include a toll free telephone number to enable contact with a research team member to answer any questions they may have.
Participants will self-report use of the website and/or DVD, and receipt of reminders and letter.
Intervention code [1] 293211 0
Behaviour
Comparator / control treatment
Standard care
ACP occur relatively rarely and often very close to death. Patients with cancer under the care of medical oncologists in Australia rarely complete advance care directives.
Control group
Active

Outcomes
Primary outcome [1] 296548 0
Feasibility: number of times each of the intervention components was accessed (i.e. Start2Talk website, DVD, SMS prompts) as assessed using a self-report survey with patients. The survey was designed specifically for this study. Consent rates, attrition rates will also be assessed as a measure of feasibility.
Timepoint [1] 296548 0
2 months post-recruitment
Primary outcome [2] 296549 0
Participants will self-report in the survey designed for the study about acceptability of the intervention components including: whether the letters and SMS prompts were useful; and whether the Start2Talk website and/or DVD was easy to understand.
Timepoint [2] 296549 0
2 months post-recruitment
Secondary outcome [1] 318729 0
Uptake of advance care planning:
1) Proportion of patients who have appointed an enduring guardian (or equivalent) and/or completed an advance directive. Participants will be asked to respond yes/no/unsure. If the participants indicates yes, they will be asked to provide a time estimate of when this was done (last week/fortnight/month).
2) Proportion of patients who intend to appoint an enduring guardian (or equivalent) and/or completed an advance directive. Participants will be asked to respond yes/no/unsure.
Timepoint [1] 318729 0
2 months post-recruitment
Secondary outcome [2] 318730 0
Barriers to ACP: 12 items on patient knowledge, attitudes and behaviour in relation to advance care planning will be assessed using a self-report survey designed specifically for this study.
Timepoint [2] 318730 0
2 months post-recruitment

Eligibility
Key inclusion criteria
People diagnosed with cancer, receiving care from participating oncology outpatient clinics; able to read and write English at a level that allows completion of surveys; able to provide informed consent; judged by service staff to be cognitively, emotionally and physically able to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People whose primary language is other than English (LOTE); Children and/or young people (ie. <18 years); People with an intellectual or mental impairment. Participants under the age of 18 have been excluded as they are unable to give informed consent. While it would be of interest to include non-English speaking participants, they have been
excluded due to anticipated difficulties in responding to the written survey and using the intervention which will be produced in English only. Given informed consent is required as well as completing surveys and accessing web-based and audio-visual information (for the intervention group), people with an intellectual or mental impairment have also been excluded.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation schedule will be delivered via secure web-based interface.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur as a consequence of a computer-generated random list overseen by an independent statistical unit.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Comparison of the secondary outcome (uptake ACP) between treatment arms will be achieved using a chi-square test and 95%CIs for the difference in proportions between each arm and usual care will be estimated. Assuming a 75% consent rate, 110 patients will be approached to give completed data for 80 patients. This will allow detection of a 30% difference between treatment arms and usual care with 80% power and 5 % significance for the preliminary effectiveness aim. Analysis will be done using the intention to treat framework.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/01/2016
Actual
7/03/2016
Date of last participant enrolment
Anticipated
4/04/2016
Actual
18/04/2016
Date of last data collection
Anticipated
Actual
19/09/2016
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4586 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 12191 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 292343 0
Other Collaborative groups
Name [1] 292343 0
Hunter Cancer Research Alliance (HCRA)
Country [1] 292343 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University of Newcastle
University Drive Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 291022 0
Government body
Name [1] 291022 0
Hunter New England Local Health District
Address [1] 291022 0
Hunter New England Local Health District
Locked Bag 1 New Lambton NSW 2305
Country [1] 291022 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293810 0
Hunter New England Local Health District HREC
Ethics committee address [1] 293810 0
Ethics committee country [1] 293810 0
Australia
Date submitted for ethics approval [1] 293810 0
31/08/2015
Approval date [1] 293810 0
02/11/2015
Ethics approval number [1] 293810 0
HNEHREC Reference No: 15/09/16/4.06 NSW HREC Reference No: HREC/15/HNE/351 NSW SSA Reference No: SSA/15/HNE/428

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61402 0
Dr Amy Waller
Address 61402 0
Health Behaviour Research Group (HBRG)
Level 4 West Wing
HMRI Building
University Drive
University of Newcastle
Callaghan NSW 2308
Country 61402 0
Australia
Phone 61402 0
+61 2 40420708
Fax 61402 0
Email 61402 0
amy.waller@newcastle.edu.au
Contact person for public queries
Name 61403 0
Amy Waller
Address 61403 0
Health Behaviour Research Group (HBRG)
Level 4 West Wing
HMRI Building
University Drive
University of Newcastle
Callaghan NSW 2308
Country 61403 0
Australia
Phone 61403 0
+61 2 40420708
Fax 61403 0
Email 61403 0
amy.waller@newcastle.edu.au
Contact person for scientific queries
Name 61404 0
Amy Waller
Address 61404 0
Health Behaviour Research Group (HBRG)
Level 4 West Wing
HMRI Building
University Drive
University of Newcastle
Callaghan NSW 2308
Country 61404 0
Australia
Phone 61404 0
+61 2 40420708
Fax 61404 0
Email 61404 0
amy.waller@newcastle.edu.au

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.