Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000010695
Ethics application status
Approved
Date submitted
30/11/2022
Date registered
9/01/2023
Date last updated
21/01/2024
Date data sharing statement initially provided
9/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Integrating Palliative Care in Liver Cancer Care Pathways
Scientific title
Implementing palliative care in hepatocellular carcinoma ambulatory clinics: A phase III cluster based non-randomised controlled trial of symptom assessment supported by a clinical care pathway on the incidence of palliative care symptoms in adult patients attending ambulatory hepatocellular carcinoma clinics
Secondary ID [1] 308524 0
None
Universal Trial Number (UTN)
Trial acronym
APriCa-PC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular carcinoma 328349 0
Palliative care 328350 0
Condition category
Condition code
Cancer 325389 325389 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention sites will implement the model as standard practice within their ambulatory care clinic model. As this is a cluster based trial with patient allocation at level of hospital, patients will be allocated to intervention or control based upon attendance at their regular clinic. This model will require patients to perform Liver-specific Edmonton Symptom Assessment scale, and European Organisation for Research and Treatment of Cancer Quality of Life questionnaire, and their carers to perform a Carer-Support Needs Assessment Tool (CSNAT) questionnaire at their ambulatory care appointments for liver cancer every 3 months as part of their regular scheduled follow up. These questionnaires take around 10-15 minutes to complete. Based on the agreed framework, if a patient’s symptom reaches a certain threshold, this will trigger referral to palliative care services. Palliative care services will review these patients and carers, and institute standard management and treatment, as required. These questionnaires will be entered electronically into REDCap on iPads at each of the clinic sites. Automatic generation of notification of moderate-severe symptoms (liver specific ESAS >4) at intervention sites will be emailed to study co-ordinator and HCC clinical nurse consultants, who will notify the relevant specialist to trigger referral to palliative care. Palliative care services will entail a comprehensive clinical review and tailored symptom management, with additional supportive management and interdisciplinary referral as per the standard palliative care clinical guidelines. Completed liver specific ESAS forms will be monitored, as well as palliative care referral rates from intervention sites will be utilised to review adherence to the study protocol.
Intervention code [1] 324964 0
Behaviour
Intervention code [2] 324965 0
Treatment: Other
Comparator / control treatment
Participating centres will be provided with an electronic system for screening patients using the liver-specific Edmonton Symptom Assessment scale, and quality of life (European Organisation for Research and Treatment of Cancer Quality of Life QLQ-30 questionnaire). Patients will be screened at each ambulatory liver cancer clinic appointment. Screening tools and patient-held resources will be translated to support communication by non-English speaking patients, who are at special risk for poor outcomes. These will be submitted for ethics approval once the translations are completed, however in the interim the validated English versions will be utilised for patients who have appropriate level of English to complete the form. Staff at these centres will be at liberty to use this screening data in any way they wish. Referral to palliative care services should continue as usual care for palliative/supportive care referral in liver cancer. Currently the standard of care is referral to palliative/supportive care services if the patient has Barcelona Clinic Liver Cancer class D (very advanced disease). Patients will be allocated to intervention or control sites based upon the hospital that they attend for their regular liver cancer treatment.
Control group
Active

Outcomes
Primary outcome [1] 333244 0
Change in mean symptom score of liver specific ESAS palliative care symptoms with moderate-severe symptoms
Timepoint [1] 333244 0
3 months post identification of moderate-severe symptoms on liver specific ESAS which is performed every 3 months as part of normal liver clinic appointments
Primary outcome [2] 333310 0
Change in individual scores of liver specific ESAS palliative care symptoms with moderate-severe baseline
Timepoint [2] 333310 0
3 months post identification of moderate-severe symptoms on liver specific ESAS which is performed every 3 months as part of normal liver clinic appointments
Secondary outcome [1] 416312 0
Change in mortality
Timepoint [1] 416312 0
Baseline, 12 months post enrolment, 24 months post enrolment, 36 months post enrolment, 48 months post enrolment, end of trial
Secondary outcome [2] 416581 0
Change in quality of life assessing using the European Organisation for Research and Treatment of Cancer Quality of Life QLQ-30 questionnaire
Timepoint [2] 416581 0
Baseline, 12 months post enrolment, 24 months post enrolment, 36 months post enrolment, 48 months post enrolment, end of trial
Secondary outcome [3] 416582 0
Change in palliative care referral rates assessed by audit of electronic medical records
Timepoint [3] 416582 0
Baseline, 12 months post enrolment, 24 months post enrolment, 36 months post enrolment, 48 months post enrolment, end of trial
Secondary outcome [4] 416583 0
Change in patient empowerment using the Health Education Impact Questionnaire
Timepoint [4] 416583 0
Baseline, 12 months post enrolment, 24 months post enrolment, 36 months post enrolment, 48 months post enrolment, end of trial
Secondary outcome [5] 416584 0
Change in carer experience assessed using Carer-Support Needs Assessment Tool for carers of advanced cancer
Timepoint [5] 416584 0
Baseline, 12 months post enrolment, 24 months post enrolment, 36 months post enrolment, 48 months post enrolment, end of trial
Secondary outcome [6] 416585 0
Change in liver-specific hospital admission rates assessed using electronic medical records
Timepoint [6] 416585 0
Baseline, 12 months post enrolment, 24 months post enrolment, 36 months post enrolment, 48 months post enrolment, end of trial
Secondary outcome [7] 416586 0
Change in non-liver specific hospital admission rate assessed using electronic medical records
Timepoint [7] 416586 0
Baseline, 12 months post enrolment, 24 months post enrolment, 36 months post enrolment, 48 months post enrolment, end of trial

Eligibility
Key inclusion criteria
Sites will be ambulatory liver cancer clinics at participating hospitals.
Participants will include patients, carers and centre staff at each site.

Inclusion criteria: Liver cancer patients
1. Attend a participating liver cancer and palliative care centre as an outpatient during the study period
2. Have a diagnosis of current active liver cancer
3. Be able to self-complete a 0-10 liver-specific Edmonton Symptom Assessment scale (ESAS)

Inclusion criteria for carers will be:
1. Identified by a patient who has completed the symptom and needs assessment as providing them with substantial emotional and practical support in an unpaid capacity
2. Have spoken and written English proficiency sufficient to complete the Carer-Support Needs Assessment Tool (CSNAT).

Inclusion criteria for centre staff :
1. Employed full- or part-time at a participating cancer or palliative care centre in a role that provides clinical care to patients with liver cancer
2. Provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for liver cancer patients:
1. Patients with Barcelona Clinic Liver Cancer (BCLC) stage A disease and no underlying liver disease
2. Patients with advanced disease (BCLC D) where inpatient care or direct referral to palliative care has been performed prior to ambulatory liver cancer clinic appointment.
3. Those who opt-out of completing the ESAS and needs assessment as part of their clinic assessment.
4. Participation at another centre taking part in the trial;
5. Documented as having cognitive impairment that would preclude capacity to give informed consent.

Exclusion criteria for carers:
1. Those who opt-out of completing the needs assessment as part of the assessment of the person for whom they are providing care.

Study design
Purpose of the study
Educational / counselling / training
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/07/2022
Date of last participant enrolment
Anticipated
28/07/2027
Actual
Date of last data collection
Anticipated
28/07/2031
Actual
Sample size
Target
500
Accrual to date
89
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23654 0
Westmead Hospital - Westmead
Recruitment hospital [2] 23655 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 23656 0
St George Hospital - Kogarah
Recruitment hospital [4] 23657 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 39076 0
2050 - Camperdown
Recruitment postcode(s) [2] 39075 0
2145 - Westmead
Recruitment postcode(s) [3] 39078 0
2170 - Liverpool
Recruitment postcode(s) [4] 39077 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 312763 0
Government body
Name [1] 312763 0
Cancer Institute NSW
Country [1] 312763 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 314393 0
None
Name [1] 314393 0
Address [1] 314393 0
Country [1] 314393 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312063 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 312063 0
South Western Sydney Local Health District Executive Office
Liverpool Hospital Eastern Campus
Scrivener Street
LIVERPOOL NSW 2170
Ethics committee country [1] 312063 0
Australia
Date submitted for ethics approval [1] 312063 0
21/11/2021
Approval date [1] 312063 0
25/05/2022
Ethics approval number [1] 312063 0
2022/ETH00385

Summary
Brief summary
This study aims to evaluate the effectiveness of a symptom assessment supported by a clinical care pathway for adult patients with liver cancer who are attending ambulatory liver cancer clinics.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with an active liver cancer and you are attending one of the participating liver cancer and palliative care centres as an outpatient (Royal Prince Alfred Hospital, Westmead Hospital, Liverpool Hospital and St George Hospital). Unpaid carers for eligible patients will also be invited to participate.

Study details
Depending upon the hospital/clinical care centre that participants would normally attend they will either continue to be treated per the current care guidelines or they will be invited to participate in the intervention model of care. Participants who attend either of the usual care or intervention centres will be asked to complete two questionnaires about their symptoms and quality of life at each of their scheduled visits, and will be provided with instructions that they can raise any symptom concerns with their treating clinician at their appointment. Completion of the questionnaires is anticipated to take 10-15 minutes.
Carers of participants who attend one of the intervention centres will also be asked to complete a questionnaire about their support needs. For participants and carers who attend one of the intervention centres, the questionnaire responses will be assessed against a set of criteria. If the participant is experiencing a decrease in their quality of life, an increase in their symptoms and/or severity of symptoms, or the carer has identified that their support needs are not being met this will trigger a referral to be sent to palliative care services. Participants who receive this referral will also be reviewed by a Palliative Medicine Specialist for further clinical review so that they may be provided with personalised symptom management, other supportive management and interdisciplinary referral as required.

It is hoped this research will determine whether implementation of a symptom and needs-based assessment framework for additional palliative care services is feasible and whether this framework has a positive impact on the quality of care of patients with liver cancer. If the assessment framework model of care is seen to have a positive impact, it may be expanded to include a greater number of clinic care centres which would allow further patients with liver cancer to receive more personalised care.
Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123330 0
Prof Jacob George
Address 123330 0
Storr Liver Centre
Gastroenterology & Hepatology,
Westmead Hospital
Cnr Hawkesbury Road and, Darcy Rd,
Westmead NSW 2145
Country 123330 0
Australia
Phone 123330 0
+61 2 8890 7705
Fax 123330 0
Email 123330 0
jacob.george@sydney.edu.au
Contact person for public queries
Name 123331 0
Dr Cameron Gofton
Address 123331 0
Storr Liver Centre
Gastroenterology & Hepatology,
Westmead Hospital
Cnr Hawkesbury Road and, Darcy Rd,
Westmead NSW 2145
Country 123331 0
Australia
Phone 123331 0
+61 2 8627 3542
Fax 123331 0
Email 123331 0
cameron.gofton@health.nsw.gov.au
Contact person for scientific queries
Name 123332 0
Prof Meera Agar
Address 123332 0
Professor of Palliative Medicine
IMPACCT, Faculty of Health
University of Technology Sydney
235 Jones St, Ultimo NSW 2007
Country 123332 0
Australia
Phone 123332 0
+61 2 8738 3000
Fax 123332 0
Email 123332 0
meera.agar@uts.edu.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.