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Trial registered on ANZCTR


Registration number
ACTRN12613001288718
Ethics application status
Approved
Date submitted
15/10/2013
Date registered
21/11/2013
Date last updated
21/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Advance care planning (ACP) in incurable cancer patients with disease progression on first line chemotherapy: a randomised trial
Scientific title
A randomised control trial to evaluate the effect of a formal advance care planning (ACP) intervention compared to standard practice on the documentation of patient wishes, compliance with known end of life (EOL) wishes and the quality of death of patients with progressive incurable cancer on first line chemotherapy.
Secondary ID [1] 283218 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 290088 0
end of life decision making 290090 0
Condition category
Condition code
Cancer 290464 290464 0 0
Any cancer
Public Health 290967 290967 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Advance Care Planning (ACP) refers to the process by which patients, families and health professionals (HPs) discuss and establish future goals of care in accordance with the patient’s values and preferences.
ACP provides a formal means of informing health professionals and family of the patient’s wishes. If patients become too ill to make decisions, documentation of their preferences regarding End of Life (EOL) care will enable patients to receive the care they would have chosen. Moreover, ACP can relieve the burden of decision-making for family members. ACP is patient-centred in that it promotes shared-decision-making, supports substitute decision-making where appropriate and aims to achieve good EOL care. For this trial ACP will be administered in a face to face meeting by a specially trained nurse. The session will take between half an hour to 3 hours over 1 to 3 visits to complete, depending on patient preferences.
Intervention code [1] 287946 0
Other interventions
Comparator / control treatment
Standard care.
EOL discussions occur relatively rarely and often very close to death. Patients with metastatic incurable cancer under the care of medical oncologists in Australia rarely complete advance care directives.
Control group
Active

Outcomes
Primary outcome [1] 290491 0
Documentation of patients end of life wishes and compliance with known end of life wishes measured by medical record review and standardized study developed scoring system.
Timepoint [1] 290491 0
Within 3 weeks of the patients death
Secondary outcome [1] 304628 0
Quality of death measured using the 'Quality of End of Life and Satisfaction with Care questionnaire', a study developed questionnaire (comprising 26 questions) measuring nominated family or friends-assessed satisfaction with the quality of a patient’s death, from their own and perceived perspective of the deceased patient.
Timepoint [1] 304628 0
3 months after bereavement
Secondary outcome [2] 304629 0
Patient and nominated family or friend satisfaction with care measured using a 5 question survey utilised in our previous trial. This survey focuses on satisfaction with information provision and communication with medical staff.
Timepoint [2] 304629 0
At 6 weeks, every 3 months until the patients death
Secondary outcome [3] 304630 0
Patient/family and Patient/healthcare provider communication about end of life care: measured using a study developed questionnaire adapted from 3 items from Wright et al (Wright 2008)
Timepoint [3] 304630 0
Baseline and 6 weeks only
Secondary outcome [4] 304634 0
Patient understanding of life expectancy/survival time measured using an instrument developed by our group in previous studies of cancer patients.
Timepoint [4] 304634 0
At baseline and at 6 weeks
Secondary outcome [5] 304635 0
Impact of the death on the nominated family or friend measured by the impact of events scale (IES), a validated 15 item tool that identifies the risk of developing post-traumatic stress disorder, and the14 item hospital anxiety and depression scale (HADS).
Timepoint [5] 304635 0
At baseline, 6 weeks, every 3 months until; bereavement and 3 months after bereavement
Secondary outcome [6] 304636 0
Quality of life for both patients and nominated family or friends. This will be assessed using a standard multi-attribute utility instrument EQ-5DL for patients and SF-12 for nominated family or friends.
Timepoint [6] 304636 0
At baseline, 6 weeks, every 3months until death or bereavement. Also at 3 months after bereavement for nominated family or friends.
Secondary outcome [7] 304637 0
Valuing quality of life measured using a short survey – the discrete choice experiment (DCE). Patients and nominated family or friends are presented with a short description of a health state, then asked to compare 2 descriptions and select which represents the better or more desired situation. Each respondent will answer 8-10 comparisons.
Timepoint [7] 304637 0
At 6 weeks
Secondary outcome [8] 304638 0
Costing and health care use both patient and nominated family or friend. We will collect detailed resource use data on study participants consisting of of Commonwealth Medicare and PBS records which provide detailed accounts of medical service use and pharmaceutical consumption. We will seek consent to access state based records on hospital admissions and emergency department visits, for example through the Centre for Health Record Linkage (CHeReL) in NSW, and similar in other States. In addition, we will directly ask patients about their health care use of services and products that are beyond the scope of the administrative datasets such as their use of (and expenditure on) over-the-counter medication, alternative therapies, community and allied health services. This will be collected by a short series of questions on health service use as part of the telephone interview. Costs will be obtained by using a standard schedule of prices, including MBS fees, PBS costs, hospital activity funding prices (to be introduced in 2012) and self-reported out-of-pockets checked against common prices. The cost of advanced care planning will be estimated based on a time-and-motion study from a sample of patients in the study. We observe the length of time taken to undertake advanced care planning as well as recording associated activities (including training) of the health professional involved.
Timepoint [8] 304638 0
Throughout the length of the trial

Eligibility
Key inclusion criteria
Diagnosis of an incurable cancer with disease progression on first line chemotherapy and an expected median survival of less than 12 months.
Able to nominate one (only) family member or friend who is willing to participate in the study
18 years of age or over
Able to read and write English
Able and well enough to read a booklet and complete some questionnaires (e.g. can’t be confused)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous formal advance care planning

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)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number tables will be used to generate randomisation blocks, to ensure equal numbers across the groups.
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
Assuming a baseline rate of EOL wishes at 30% based on a previous trial in non-cancer patients, and believing a doubling to 60% would influence clinical practice, two study groups with 63 patients will result in the study having 90% power to detect a between-group difference with 95% certainty. A conservative estimate of mortality at 12 months is 50%. To allow for 25% of patients not to complete ACP within 2 weeks of enrolment or the initial 6 week assessment and patient/carer loss to follow up of 10-20%, we propose a sample size of 334 patients-carer dyads (668 participants in total).

Statistical methods: The primary outcome is knowledge of and adherence to EOL wishes which will be assessed by using chi-squared tests for categorical outcomes and t-tests for continuous outcomes. Outcomes which are measured repeatedly will be analysed with mixed models, to assess patterns over time as well as differences between group at specific time points.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/02/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
668
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 1512 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 1513 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 1514 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [4] 1515 0
Concord Repatriation Hospital - Concord
Recruitment hospital [5] 1516 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [6] 1517 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 7352 0
2006 - The University Of Sydney
Recruitment postcode(s) [2] 7353 0
2065 - Royal North Shore Hospital
Recruitment postcode(s) [3] 7354 0
2560 - Campbelltown
Recruitment postcode(s) [4] 7355 0
2138 - Concord West
Recruitment postcode(s) [5] 7356 0
3084 - Heidelberg
Recruitment postcode(s) [6] 7357 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 287969 0
Government body
Name [1] 287969 0
The National Health and Medical Research Council
Country [1] 287969 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
Camperdown
Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 286687 0
University
Name [1] 286687 0
The University of Technology
Address [1] 286687 0
15 Broadway
Ultimo
NSW 2007
Country [1] 286687 0
Australia
Secondary sponsor category [2] 286688 0
Hospital
Name [2] 286688 0
Austin Health
Address [2] 286688 0
145 Studley Rd
Heidelberg
VIC 3084
Country [2] 286688 0
Australia
Secondary sponsor category [3] 286689 0
Hospital
Name [3] 286689 0
Ludwig Institute for Cancer Research
Address [3] 286689 0
Level 5, Olivia Newton-John Cancer & Wellness Centre, Austin Health, 145-163 Studley Road
Heidelberg, VIC, au, 3084
Country [3] 286689 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289894 0
Sydney Local Health District HREC
Ethics committee address [1] 289894 0
Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN
NSW 2050
Ethics committee country [1] 289894 0
Australia
Date submitted for ethics approval [1] 289894 0
20/02/2013
Approval date [1] 289894 0
18/03/2013
Ethics approval number [1] 289894 0
X13-0064

Summary
Brief summary
This project aims to evaluate the effect of a formal advance care planning intervention (ACP) on the documentation of patient wishes, compliance with known end of life (EOL) wishes and the quality of death of patients with progressive incurable cancer on first line chemotherapy. 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 an incurable cancer with disease progression on first line chemotherapy. Eligible patients must be able to nominate a family member or friend who is willing to participate in the study who is 18 years of age or over. Study details Patients and their family/friend/carer will be randomly (by chance) allocated to one of two groups. Participants in one group will receive standard end of life care. Participants in the other group will receive standard care plus a formal advance care planning intervention. All patients and family who request information on life expectancy will be provided with typical, best case and worst case scenarios for survival time. The intervention aims to promote discussion between patient and family and the health care team and to promote documentation of the patient’s preferences for continuing and EOL care. The intervention involves the patient plus a family member or friend meeting with a specially trained nurse to have conversations about their goals, wishes and needs for care now and in the future, as well as how these matters will be shared with their doctor and health care team. For those patients allocated to the group who receive the intervention, this program will take between half an hour to 3 hours over 1 to 3 visits to complete, depending on patient preference. Patients will be asked to complete some questionnaires at baseline, 6 weeks, and every 3 months thereafter to evaluate quality of life and satisfaction with care. The patient’s family/friend/carer will also be asked to complete some questionnaires at baseline, 6 weeks, every 3 months until the patient’s death, and then at 3 months after bereavement to evaluate their perceived quality of death and the impact of death on surviving family. The costs of care will also be assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42962 0
Prof Martin Tattersall
Address 42962 0
Cancer Medicine - CCS
Rm 391 Blackburn Building
University of Sydney
NSW 2006
Country 42962 0
Australia
Phone 42962 0
61 2 9351 3675
Fax 42962 0
Email 42962 0
[email protected]
Contact person for public queries
Name 42963 0
Stephanie Johnson
Address 42963 0
Cancer Medicine - CCS
Rm 391 Blackburn Building
University of Sydney
NSW 2006
Country 42963 0
Australia
Phone 42963 0
+61295134105
Fax 42963 0
Email 42963 0
[email protected]
Contact person for scientific queries
Name 42964 0
Martin Tattersall
Address 42964 0
Cancer Medicine - CCS
Rm 391 Blackburn Building
University of Sydney
NSW 2006
Country 42964 0
Australia
Phone 42964 0
61 2 9351 3675
Fax 42964 0
Email 42964 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

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