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
ACTRN12617000534381
Ethics application status
Approved
Date submitted
7/04/2017
Date registered
12/04/2017
Date last updated
20/03/2019
Date data sharing statement initially provided
20/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Phase II Trial to Examine Feasibility of Standardised, Early Palliative (STEP) Care for Patients with Advanced Cancer and their Families
Scientific title
A Randomised Phase II Trial to Examine Feasibility of Standardised, Early Palliative (STEP) Care for Patients with Advanced Cancer and their Families
Secondary ID [1] 291645 0
Nil known
Universal Trial Number (UTN)
U1111-1195-2394
Trial acronym
STEP Care Trial
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 302793 0
Prostate Cancer 302794 0
High-grade glioma 302795 0
Condition category
Condition code
Cancer 302291 302291 0 0
Breast
Cancer 302292 302292 0 0
Prostate
Cancer 302293 302293 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Usual oncology care + STEP Care - standardized early palliative care introduced at key transition points in the cancer illness trajectory. The specific transition points for each cancer are:
- Breast: any overnight/multiday inpatient hospital admission with at least one visceral metastasis
- Prostate cancer: any overnight/multiday inpatient hospital admission with any metastasis
- High-grade glioma: any hospital presentation (inpatient or outpatient) with recurrence of grade IV disease
STEP Care involves palliative care consultation within 14 days of the transition point, with follow-up occurring at minimum monthly for 3 months +/- an additional 3 month bolster as needed (determined by the treating palliative care specialist in consultation with patient and their caregiver).
STEP Care is delivered by specialist palliative care consultants, or certified nurse practitioners/ clinical nurse specialists.
The care provided will be personalized based upon patient and caregiver need, including review of: symptoms, psychological distress, additional community supports required, informational needs, illness understanding, discussion of prognosis, preferences for care, advance care planning, GP case conference.
STEP Care is provided face-to-face upfront, with follow-up either face-to-face or by telephone as needed.
Caregivers are invited to participate in consultations.
All STEP Care consultations are audio-recorded for auditing, and cross-checked against standardised documentation regarding the consultations completed by treating palliative care specialist.
Intervention code [1] 297726 0
Treatment: Other
Comparator / control treatment
Control: Usual oncology care (including palliative care with referral at the discretion of the treating clinician)
Control group
Active

Outcomes
Primary outcome [1] 301699 0
Feasibility: study enrolment of 120 patients across study sites in 24 months
Timepoint [1] 301699 0
Study Close: 24 months
Primary outcome [2] 301700 0
Feasibility: at least 60% of enrolled participants progressing to study completion
Timepoint [2] 301700 0
T3: 12 weeks after baseline
Secondary outcome [1] 333595 0
Patient Quality of life at the end of life (QUAL-E)
Timepoint [1] 333595 0
T3: 12 weeks after baseline
Secondary outcome [2] 333596 0
Patient Health-related quality of life/ symptom impact (QLQ-C30)
Timepoint [2] 333596 0
T3: 12 weeks after baseline
Secondary outcome [3] 333597 0
Patient Mood (stress, anxiety, depression) (DASS-21)
Timepoint [3] 333597 0
T3: 12 weeks after baseline
Secondary outcome [4] 333613 0
Patient performance status (AKPS)
Timepoint [4] 333613 0
T3: (12 weeks after baseline)
Secondary outcome [5] 333614 0
Carer Preparedness to care (PCS)
Timepoint [5] 333614 0
T3 (12 weeks after baseline)
Secondary outcome [6] 333616 0
Quality of end of life care in the last month of life (Medical record review)
- Chemotherapy use
- >1 ED visit
- >1 acute hospital admission
- Total length of stay > 14 days
- Intensive care admission
- Place of death
Timepoint [6] 333616 0
Following death
Secondary outcome [7] 333617 0
Carer Satisfaction with Care (FAMCARE-2)
Timepoint [7] 333617 0
T5: 12 weeks after patient death
Secondary outcome [8] 333618 0
Carer experiences of care (Qualitative interview)
Timepoint [8] 333618 0
T5: 12 weeks after patient death
Secondary outcome [9] 333619 0
Patients: overall survival
Timepoint [9] 333619 0
Date of death
Secondary outcome [10] 333622 0
Patients: quality-adjusted survival (QLU-C10U)
Timepoint [10] 333622 0
quality of life measures (QLU-C10U) and survival at T4 (24 weeks post baseline)
Secondary outcome [11] 333623 0
Incremental cost effectiveness (data linkage to MBS/PBS records)
Timepoint [11] 333623 0
Study close
Secondary outcome [12] 333670 0
Carer Quality of life (CQOL-C)
Timepoint [12] 333670 0
T3: 12 weeks after baseline
Secondary outcome [13] 333671 0
Carer Mood (stress, anxiety, depression) (DASS-21)
Timepoint [13] 333671 0
T3: 12 weeks after baseline

Eligibility
Key inclusion criteria
Patients:
1) Diagnosis of:
a) Prostate cancer with any metastases
b) Breast cancer with at least one visceral metastasis
c) Grade IV brain tumour / GBM – recurrent disease or no cancer treatment prescribed
2) Within 2 weeks of multi-day admission
3) Able to provide informed consent/ comply with study procedures.

Caregiver:
1) Nominated by eligible patient as a person involved in their care.
2) Able to provide informed consent/ comply with study procedures.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients:
- Outside 2 weeks of defined transition point
- Previous palliative care referral
- Needs imminent palliative care referral
- Non-English speaking/ not able to complete study measures
- Cognitive issues/ not able to complete informed consent

Caregivers:
- Non-English speaking/ not able to complete study measures

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)
Allocation concealment involving contacting central administration site/ holder of allocation schedule using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization
Stratified by study site and cancer diagnosis
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Group differences and variance across preliminary efficacy outcomes for patients (QOL, HRQOL, Mood, Performance Status) and carers (QOL, Mood, Preparedness to care, Satisfaction with Care) will be compared between treatment groups, after adjusting for baseline levels of covariance (ANCOVA). Separate models will be tested for patients and caregivers. A power analysis indicates with the target sample size, a power of 80% and an alpha of 0.05, the minimum detectable different is 0.46 standard deviations between the treatment groups (n=60 per group). For contrasts between sites (n=40) and tumour type (n=40), the minimum detectable pairwise difference is 0.57.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/04/2017
Date of last participant enrolment
Anticipated
4/04/2020
Actual
Date of last data collection
Anticipated
4/10/2020
Actual
Sample size
Target
120
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7801 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 7802 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 7803 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [4] 13454 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 15732 0
3065 - Fitzroy
Recruitment postcode(s) [2] 15733 0
3050 - Royal Melbourne Hospital
Recruitment postcode(s) [3] 15735 0
3000 - Melbourne
Recruitment postcode(s) [4] 26061 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 296138 0
Government body
Name [1] 296138 0
Victorian Cancer Agency
Country [1] 296138 0
Australia
Primary sponsor type
Individual
Name
Prof Jennifer Philip
Address
VCCC Chair of Palliative Medicine
Room 311, Level 3 Daly Wing, St Vincent’s Hospital, 41 Victoria Parade Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 295041 0
None
Name [1] 295041 0
Address [1] 295041 0
Country [1] 295041 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297390 0
St Vincent's Human Research Ethics Committee
Ethics committee address [1] 297390 0
Ethics committee country [1] 297390 0
Australia
Date submitted for ethics approval [1] 297390 0
Approval date [1] 297390 0
07/02/2017
Ethics approval number [1] 297390 0
179/16

Summary
Brief summary
The primary purpose of this trial is to evaluate the feasibility of implementing standardised early palliative (STEP) care for advanced breast, prostate and brain cancer patients.

Who is it for?
You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with prostate cancer with metastases, breast cancer with at least one visceral metastasis or grade IV brain tumour/glioblastoma with recurrent disease or no cancer treatment prescribed, and their nominated carer. You must have been admitted to hospital for a stay lasting more than one day in the previous two weeks.

Study details
All participants enrolled in this trial will be randomly allocated (by chance) to receive either standard care or to receive the STEP care intervention in addition to standard care. Participants allocated to the STEP care intervention will receive palliative care consultations (with their carer) at least once per month for three months. If the treating doctor/nurse determines that further palliative care would be beneficial then another three months of consultations may be provided. The palliative care is tailored to the needs of the person and their carer, but will include review and management of any symptoms of concern, referral for additional supports as required, review of informational needs, addressing illness understanding and discussion of prognosis, assistance with care planning, case conference with the person's GP. Researchers will monitor whether the implementation of this program, and whether recruitment into this trial are feasible, as well as asking all participants to complete a number of questionnaires to determine whether the STEP care intervention benefits patient and carer outcomes such quality of life, mood, and survival and reduces time spent in hospital.

It is hoped that the results of this pilot trial will inform a future large scale trial to evaluate whether standardised early palliative care is beneficial for advanced cancer patients and their carers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73898 0
Prof Jennifer Philip
Address 73898 0
Room 311, Level 3 Daly Wing, St Vincent’s Hospital, 41 Victoria Parade Fitzroy VIC 3065
Country 73898 0
Australia
Phone 73898 0
+61 3 9231 1155
Fax 73898 0
Email 73898 0
[email protected]
Contact person for public queries
Name 73899 0
Prof Jennifer Philip
Address 73899 0
Room 311, Level 3 Daly Wing, St Vincent’s Hospital, 41 Victoria Parade Fitzroy VIC 3065
Country 73899 0
Australia
Phone 73899 0
+61 3 9231 1155
Fax 73899 0
Email 73899 0
[email protected]
Contact person for scientific queries
Name 73900 0
Prof Jennifer Philip
Address 73900 0
Room 311, Level 3 Daly Wing, St Vincent’s Hospital, 41 Victoria Parade Fitzroy VIC 3065
Country 73900 0
Australia
Phone 73900 0
+61 3 9231 1155
Fax 73900 0
Email 73900 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent not obtained for IPD


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
SourceTitleYear of PublicationDOI
EmbaseThe feasibility of triggers for the integration of Standardised, Early Palliative (STEP) Care in advanced cancer: A phase II trial.2022https://dx.doi.org/10.3389/fonc.2022.991843
EmbaseA randomised phase II trial to examine feasibility of standardised, early palliative (STEP) care for patients with advanced cancer and their families [ACTRN12617000534381]: A research protocol.2019https://dx.doi.org/10.1186/s40814-019-0424-7
N.B. These documents automatically identified may not have been verified by the study sponsor.