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Trial registered on ANZCTR


Registration number
ACTRN12624001173583
Ethics application status
Approved
Date submitted
5/09/2024
Date registered
25/09/2024
Date last updated
25/09/2024
Date data sharing statement initially provided
25/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Standardised Early Palliative Care For Patients With Aggressive Haematological Malignancies
Scientific title
Acceptability of Standardised Early Palliative Care For Patients With Aggressive Haematological Malignancies
Secondary ID [1] 312909 0
Nil
Universal Trial Number (UTN)
Trial acronym
EPiC-Haem
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Leukaemia 335064 0
Aggressive Lymphoma 335065 0
Myeloma 335066 0
Steroid refractory Graft Versus Host Disease 335067 0
Condition category
Condition code
Cancer 331573 331573 0 0
Leukaemia - Acute leukaemia
Cancer 331574 331574 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 331575 331575 0 0
Hodgkin's
Cancer 331576 331576 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Education on the rationale for and design of the study will be provided to the haematology department at Austin Health. This will be provided as a single one hour online session delivered by a palliative care physician in which the project rationale, study design and role of palliative care services will be discussed. Session attendance will be recorded. Additional sessions will be provided for those unable to attend this session.

Patients who meet the eligibility criteria will receive standardised early palliative care referral.

Prior to enrolment patients will be advised of the role of palliative care in helping to control patients physical and emotional symptoms associated with their diagnosis and in helping to provide advice regarding advanced care planning. They will be advised that palliative care physicians and/or nurses will review them at 4 weekly intervals and provide a comprehensive assessment at each time point (Weeks 0,4,8,12).

Patients who decline to participate in the study or who are not eligible can continue to access palliative care support.

Participants will be asked to provide written informed consent.
Patient participants will be asked to nominate a primary caregiver.

Patient participants will be reviewed at weeks 0, 4, 8 and 12. Additional reviews will be provided as required outside of these time points based on patient need. Each review will include a review of the patient's current medical conditions, physical symptoms, emotional symptoms and goals of care. Interventions will be implemented to address each of these domains and response to each will be recorded at subsequent reviews. Interventions will depend on patient need and may include medication changes, referral to other services including psychology, spiritual care, community palliative care, physiotherapy, occupational therapy, radiation oncology or interventional radiology. It is anticipated that initial reviews will take 1 hour and subsequent reviews between 30 minutes to 1 hour. The initial review will be face-to-face. Subsequent reviews may be completed face-to-face or via telehealth depending on the patient's condition. All efforts will be made to minimise additional travel for the patient.

Patient and primary caregivers will be asked to complete quality of life assessment surveys prior to initial palliative care review (t= 0 weeks) and at weeks 4, 8, 12 and 16.

Patient records will be audited to assess baseline demographics, symptoms and interventions to ensure that adequate palliative care reviews are completed.

At the end of the mandated study visits patients can either be discharged from the service or continue to be seen based on clinician assessment and patients need.

Patients may be referred to external community palliative care services if required.

We will analyse health care resource utilisation for enrolled participants at the primary hospital only. These data will be compared to historical matched controlled data.

Clinical haematologists will be asked to complete a survey prior to enrolment of the first patient patient participant and following completion of all patient and primary caregiver data collection. These surveys relate to attitudes toward palliative care services and referral practices.
Intervention code [1] 329443 0
Treatment: Other
Comparator / control treatment
There will not be a control group for:
- quality of life assessment tools for patient and primary caregiver participants
- for clinical hematologists.

A historical matched control cohort will be used as a comparator group for health care resource utilisation. 25 historical controls will be matched on age and diagnosis from patients who completed all of their treatment for their haematological malignancy at Austin Hospital between January 2021 and December 2023.
Control group
Historical

Outcomes
Primary outcome [1] 339311 0
Composite primary outcome of acceptability of early palliative care referral for patients with aggressive haematological malignancy from a patient and haematologist point of view.
Timepoint [1] 339311 0
Acceptability will be assessed at completion of the recruitment period on 3rd February 2025.
Secondary outcome [1] 439423 0
Health care resource utilisation at Austin Health when compared to historical matched controls.
Timepoint [1] 439423 0
12 weeks post-study commencement.
Secondary outcome [2] 439424 0
Patient quality of life measurement using a haematological malignancy specific patient-reported outcome measure called HM PRO
Timepoint [2] 439424 0
At each of the study reviews (Initial review, 4 weeks, 8 weeks, 12 weeks) and four weeks after last study review (16 weeks)
Secondary outcome [3] 439425 0
Patient quality of life measurement using the European Organisation For Research And Treatment of Cancer - C15 Palliative care questionnaire (EORTC QLQ-c15-PAL)
Timepoint [3] 439425 0
At each of the study reviews (Initial review, 4 weeks, 8 weeks, 12 weeks) and four weeks after last study review (16 weeks)
Secondary outcome [4] 439629 0
Primary caregiver quality of life measurement using the Caregiver Quality of Life Questionnaire Cancer (CQOLC) survey.
Timepoint [4] 439629 0
At each of the study reviews (Initial review, 4 weeks, 8 weeks, 12 weeks) and four weeks after last study review (16 weeks)

Eligibility
Key inclusion criteria
The inclusion criteria for patients are:

Patients with haematological malignancies with poor prognosis defined as adult patients with:
Acute leukaemia:
Age > 70 years or
Age < 70 years not in complete remission after two lines of prior therapy

Aggressive lymphoma:
Relapsed or refractory aggressive lymphoma ineligible for or relapsing/non-response after autologous stem cell transplant or CAR-T cell therapy
Relapsed or refractory primary central nervous system lymphoma

Myeloma:
Symptomatic and age > 80 years

Patients with steroid refractory acute gastrointestinal graft versus host disease post allogeneic stem cell transplant.

Any patient with an haematological malignancy where in the opinion of the treating haematologist the prognosis of at least 16 weeks and less than 12 months

The inclusion criteria for primary caregivers are :
Nominated by participant as the primary caregiver at the time of enrolment.

The inclusion criteria for clinicians are :
Clinical haematologist responsible for the care of patients at the Austin Health during the study period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria for patients are:
Non-English speaking.
Previously seen by any specialist palliative care service.

The exclusion criteria for primary caregivers are:
Non-English speaking.

The exclusion criteria for clinicians
The are no exclusion criteria

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
Other
Other design features
To assess health care resource utilisation at Austin Health a historical matched control cohort will be used.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Estimation and Justification

The sample size has been estimated based on practical considerations considering the timeframe during which this study is to be completed. Patient recruitment is anticipated to run over a 5-month period from September 2024 to January 2025. Based on the number of patients who met the criteria referral in previous years it is anticipated that between 15 to 25 patients will be recruited to this study.

Power Calculations

This is a feasibility study. Power calculations have not been considered in this design. If the current model is demonstrated to be feasible power calculations will be required for further studies.

Statistical Methods to be Undertaken

Due to the limited sample size data will be reported in descriptive terms with medians and percentages. Statistical comparisons where appropriate will include Mann-Whitney U test for non-parametric data and chi-square test for proportions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2024
Actual
Date of last participant enrolment
Anticipated
2/02/2025
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27080 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 43147 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 317341 0
Other Collaborative groups
Name [1] 317341 0
North Eastern Melbourne Integrated Cancer Services
Country [1] 317341 0
Australia
Primary sponsor type
Government body
Name
Austin Health
Address
Country
Australia
Secondary sponsor category [1] 319626 0
None
Name [1] 319626 0
Address [1] 319626 0
Country [1] 319626 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316072 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 316072 0
Ethics committee country [1] 316072 0
Australia
Date submitted for ethics approval [1] 316072 0
05/06/2024
Approval date [1] 316072 0
17/06/2024
Ethics approval number [1] 316072 0
HREC/109437/Austin-2024: Standardised early palliative care for patients with aggressive haematological malignancies (EPiC-Haem)

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

Contacts
Principal investigator
Name 136686 0
Dr Myles Wright
Address 136686 0
Olivia Newton-John Cancer Wellness & Research Centre, Level 4, 145 Studley Road, Heidelberg, Victoria, 3084
Country 136686 0
Australia
Phone 136686 0
+61 03 9496 9967
Fax 136686 0
Email 136686 0
myles.wright@austin.org.au
Contact person for public queries
Name 136687 0
Myles Wright
Address 136687 0
Olivia Newton-John Cancer Wellness & Research Centre, Level 4, 145 Studley Road Heidelberg, Victoria, 3084
Country 136687 0
Australia
Phone 136687 0
+61 03 9496 9967
Fax 136687 0
Email 136687 0
myles.wright@austin.org.au
Contact person for scientific queries
Name 136688 0
Myles Wright
Address 136688 0
Olivia Newton-John Cancer Wellness & Research Centre, Level 4, 145 Studley Road Heidelberg, Victoria, 3084
Country 136688 0
Australia
Phone 136688 0
+61 03 9496 9967
Fax 136688 0
Email 136688 0
myles.wright@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
- For patients this will include: Patient demographics, diagnosis, HM PRO, EORTC QLQ-C15-PAL at each time point. Health care resource utilisation by item.
- For caregiver this will include: CQOLC Survey scores at each time point.
- Haematologist - Survey responses at each time point.
When will data be available (start and end dates)?
Immediately following publication of the study in manuscript form for a period of three years.
Available to whom?
Researchers who can provide a methodologically sound proposal.
Available for what types of analyses?
To achieve aims in the approved proposal.
How or where can data be obtained?
Proposals should be directed to myles.wright@austin.org.au
To gain access, data requestors will need to sign a data access agreement.


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.