Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000973314
Ethics application status
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Approved
Date submitted
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19/02/2026
Date registered
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7/08/2026
Date last updated
Help: Date last updated
20/10/2026
Date data sharing statement initially provided
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7/08/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Delivering better care for older people with cancer
Scientific title
Phase III hybrid effectiveness implementation step wedge cluster randomized controlled trial of implementation of a geriatric model of care to optimize outcomes for older people with cancer
Additional trial identifiers [1] 316561 0
CSTID074 V2.0
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
cancer 340721 0
Condition category
Condition code
Cancer 336910 336910 0 0
Any cancer
Public Health 336911 336911 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention is a clinical model of care, which is supported by specific strategies to support its uptake into practice (these are called implementation strategies). We will use a implementation framework which helps to understand how to put research evidence into practice (in this case a model of care for older people with cancer into cancer services). Each cluster will include three cancer services. The cluster will start the trial at two time points spaced 3 months apart. The model of care will be implemented over a 18 month period. This will include a two-month initial training period.

IMPLEMENTATION COMPONENT OF THE INTERVENTION

Implementation of the Geriatric Oncology Model of Care will be guided by the integrated Promoting Action on Research Implementation in Health Services (iPARIHS) framework with two key elements being used to support uptake into real world practice, namely facilitation, and audit and feedback of performance against the clinical pathway.

i) A Geriatric Oncology skilled facilitator in each cancer service (funded by the Medical Research Future Fund grant) will advocate for change, motivate others, and facilitate the adoption of the geriatric oncology model of care.

The skilled facilitator will assist the multidisciplinary team to identify barriers and enablers, develop clinical pathways tailored to local context, improve knowledge using evidence-based approaches (e.g., teaching on-the-run (training based on actual clinical situations health professionals are tackling in near real time) or educational outreach methods (which uses an approach of defining a few key learning messages), support multidisciplinary team discussions, support older people with cancer to engage with the assessments and clinical care pathways, and support response to the iterative data on outcomes provided through audit and feedback (3 monthly). The facilitator will have solid understanding of geriatric assessment. They may require specific training to carry out their responsibilities (e.g., data entry or conducting the practical geriatric assessment). Any required training will be identified, and appropriate instructions will be provided.

ii) Audit and feedback against clinical care pathway. Audit and feedback is a mechanism where data is collected from a range of approaches to capture how the model of care is tracking and this data is fed back to the involved clinical team who are delivering the care to reflect on and refine the model over time, hence supporting more successful adoption of the model. The audit data in this study will be a summary of clinical performance of geriatric oncology model of care every 3 months. It will include information on timeliness, adherence to steps in the pathway of care, results of the objectively measured professional practice and health care outcomes, and patient reported outcomes (PROMs) and experience (PREMs).

CLINICAL COMPONENT OF THE INTERVENTION - The geriatric model of care

The clinical model of care involves screening using the Geriatric 8 (G8) tool (which comprises of eight questions across various domains including age, nutrition, mobility, and self-rated health), conducted prior to or within two weeks of initial clinic assessment. Completion will be tailored to local context (e.g., by the skilled facilitator face-to-face or over the phone). When the G8 screen flags the need for further assessment the Practical Geriatric Assessment will be administered. Some components will be completed by patients or carers, and other components will be completed by the clinician or skilled facilitator. Clinicians from the multidisciplinary team will then determine the steps for further assessment and management according the recommendations of the Optimal Care Pathway for Older People with Cancer (Cancer Australia) prior to the cancer treatment decision being finalised. This clinical care pathway (CCP) will provide a point of care approach and include steps for further multidimensional geriatric assessment; exploration of the older persons preferences and values, and involvement of them in decision-making (including clinical trial participation); interdisciplinary referrals, support and management; and suggested longitudinal monitoring (geriatric issues, side effects of cancer treatment, unmet needs) with adaptation of care plan to meet emerging or ongoing needs. This model of care will be supported by provision of the OlderCan resources to the older person with cancer which are designed support older people with cancer to discuss their needs and what they value. This model of care will be implemented for an 18 month period, with newly eligible patients entering during the intervention phase receiving the model of care as part of standard practice. A medical record audit will be conducted to monitor adherence to the model of care.

The qualitative sub-study is an evaluation component. The sub-study consists of semi-structured interviews with older people with cancer, carers, clinicians to explore experiences, acceptability and perceptions of the geriatric oncology model of care. Participant numbers are not predetermined and recruitment will continue until data saturation is achieved. Interviews will be conducted during the intervention period, with no fixed timepoints, following participants' exposure to or involvement with the geriatric screening/assessment model of care components. Timing of interviews will be determined pragmatically to ensure participants are able to reflect on their experiences..
Intervention code [1] 333239 0
Treatment: Other
Intervention code [2] 333240 0
Early detection / Screening
Description of the comparator or control
Cancer multidisciplinary teams will routinely implement only the geriatric screening using the Geriatric-8 tool, for all ‘patient’ participants meeting eligibility prior to or within two weeks of initial clinic assessment. Screening is already routine practice in some oncology services across Australia and is recommended as best practice by the American Society of Clinical Oncology and locally by EviQ (evidence based cancer treatment protocols for point of care use) (https://www.eviq.org.au/clinical-resources/assessment-tools/4402-geriatric-8-g8-screening-tool) and will allow identification and outcome assessment of comparator at risk ‘patient’ participants. Further assessments, support and referrals required will based on current local practice.
Control group
Active

Outcomes
Primary outcome [1] 344431 0
The IMPLEMENTATION CO-PRIMARY OUTCOME is site adherence to the screening, assessment, and care approach in the geriatric oncology model of care, operationalised as the percentage of eligible patients in the cancer service 65 years and older (50 years and older for Indigenous patients) whose assessment and care was adherent (receipt of assessments and subsequent pathway directed care appropriate to their screening assessment). These elements will be assessed together.
Timepoint [1] 344431 0
This will be assessed at the end of control and intervention period.
Primary outcome [2] 344432 0
The CLINICAL CO-PRIMARY OUTCOME is Health-related quality of life.
Timepoint [2] 344432 0
This will be assessed at 3 months after initial geriatric screening assessment.
Secondary outcome [1] 457924 0
Goals and priorities
Timepoint [1] 457924 0
This will be collected at diagnosis, end of cancer treatment, and at 3-, 6-, and 12-months following initial geriatric screening assessment as part of routine clinical care.
Secondary outcome [2] 464289 0
Qualitative sub-study outcome: Involvement in decision-making including living with treatment decisions, satisfaction or utility of assessment and clinical consultations and utility of OlderCan resources. This will be assessed as composite outcome
Timepoint [2] 464289 0
Timing of interviews will be determined pragmatically during the intervention period to ensure participants are able to reflect on their experiences
Secondary outcome [3] 464297 0
Treatment recommendations
Timepoint [3] 464297 0
Data collected during control and intervention period, with cumulative data assessed at the end of each period.
Secondary outcome [4] 464299 0
Treatment modifications including dose intensity, dose delay, early termination of treatment. This will be assessed as composite outcome.
Timepoint [4] 464299 0
Data collected during control and intervention period, with cumulative data assessed at the end of each period.
Secondary outcome [5] 464300 0
Therapy toxicity
Timepoint [5] 464300 0
Data collected during control and intervention period, with cumulative data assessed at the end of each period.
Secondary outcome [6] 464301 0
Body weight
Timepoint [6] 464301 0
Data collected during control and intervention period, with cumulative data assessed at the end of each period.
Secondary outcome [7] 464305 0
Functional status
Timepoint [7] 464305 0
Data collected during control and intervention period, with cumulative data assessed at the end of each period.
Secondary outcome [8] 464306 0
Survival
Timepoint [8] 464306 0
Data collected during control and intervention period, with cumulative data assessed at the end of each period.
Secondary outcome [9] 464308 0
Clinician readiness
Timepoint [9] 464308 0
Assessed at the start of the two-month initial training period.
Secondary outcome [10] 464310 0
Unscheduled hospitalisations (number, length, Diagnosis-Related Group (DRG)). This will be assessed as a composite outcome.
Timepoint [10] 464310 0
Data collected during control and intervention period, with cumulative data assessed at the end of each period.
Secondary outcome [11] 464311 0
Emergency Department visits without admission (number, reason)
Timepoint [11] 464311 0
Data collected during control and intervention period, with cumulative data assessed at the end of each period.
Secondary outcome [12] 464312 0
Oncology assessment unit visits without admission (number, reason)
Timepoint [12] 464312 0
Data collected during control and intervention period, with cumulative data assessed at the end of each period.
Secondary outcome [13] 464313 0
Total number allied health and psychology assessments completed assessed as composite outcome
Timepoint [13] 464313 0
Data collected during control and intervention period, with cumulative data assessed at the end of each period.
Secondary outcome [14] 464314 0
Need for other specialist review (e.g., geriatrician)
Timepoint [14] 464314 0
Data collected during control and intervention period, with cumulative data assessed at the end of each period.
Secondary outcome [15] 464315 0
Residential Aged Care placement
Timepoint [15] 464315 0
Data collected during control and intervention period, with cumulative data assessed at the end of each period.
Secondary outcome [16] 464316 0
General practitioner visits
Timepoint [16] 464316 0
Data collected during control and intervention period, with cumulative data assessed at the end of each period.
Secondary outcome [17] 464317 0
Medicines use
Timepoint [17] 464317 0
Data collected during control and intervention period, with cumulative data assessed at the end of each period.
Secondary outcome [18] 464318 0
Qualitative sub-study outcome: Acceptability (composite outcome) (perception of clinicians, older people with cancer and their carers that the geriatric oncology model of care and implementation strategies are satisfactory and support addressing the needs of older cancer patients in a timely way)
Timepoint [18] 464318 0
Timing of interviews will be determined pragmatically during the intervention period to ensure participants are able to reflect on their experiences
Secondary outcome [19] 464319 0
Qualitative sub-study outcome: Appropriateness (extent to which clinicians believe the geriatric model of care and its implementation strategy has fit, relevance and compatibility at level of their setting, role and needs of older people with cancer);
Timepoint [19] 464319 0
Timing of interviews will be determined pragmatically during the intervention period to ensure participants are able to reflect on their experiences
Secondary outcome [20] 464320 0
Qualitative sub-study outcome: Feasibility (extent to which the geriatric oncology model of care is considered feasible by staff in each service, given their different needs and resources, and the degree of individual tailoring required);
Timepoint [20] 464320 0
Timing of interviews will be determined pragmatically during the intervention period to ensure participants are able to reflect on their experiences
Secondary outcome [21] 464321 0
Qualitative sub-study outcome: Penetration (number of clinicians who were aware of, engage with geriatric oncology model of care and implementation strategies)
Timepoint [21] 464321 0
Timing of interviews will be determined pragmatically during the intervention period to ensure participants are able to reflect on their experiences
Secondary outcome [22] 464322 0
Qualitative sub-study outcome: Sustainability (intention to continue or sustain roll-out of the model of care beyond the study period).
Timepoint [22] 464322 0
Timing of interviews will be determined pragmatically during the intervention period to ensure participants are able to reflect on their experiences
Secondary outcome [23] 464323 0
Implementation cost (costs of implementing the geriatric oncology model of care assessed at health service level, including resources used for delivery compared to standard reimbursements)
Timepoint [23] 464323 0
At the end of the intervention period
Secondary outcome [24] 464841 0
Qualitative sub-study outcome: Treatment decision-making practices, utility of assessment and OlderCan resources and engagement with the model of care. This will be assessed as composite outcome.
Timepoint [24] 464841 0
Timing of interviews will be determined pragmatically during the intervention period to ensure participants are able to reflect on their experiences

Eligibility
Key inclusion criteria
The population (CANCER SERVICE LEVEL AND PATIENT LEVEL) inclusion criteria are provided below:
Key inclusion criteria for cluster (cancer service level)
- Ambulatory cancer service provided by a defined multidisciplinary team (defined as either a shared clinic or by specific tumour type)
- Written informed consent of the cluster

Key inclusion criteria for patients participants
- adults aged 65 years and older (non-Indigenous) and Aboriginal and Torres Strait Islander people 50 years and older
- new diagnosis of cancer
- who have been referred to a cancer specialist and are being considered for chemotherapy, targeted therapy, or immunotherapy (including in a clinical trial).

There are three participant groups for the qualitative sub-study.
Inclusion criteria for CLINICIAN PARTICIPANTS:
- Written informed consent
- Member of the multidisciplinary team who is involved in clinical care in the ‘cluster’ (as defined above)

Inclusion criteria for INFORMAL CARERS:
- Informal carer as identified of the ‘index patient’ who received the intervention (partial or complete) in the geriatric model of care or comparator groups as identified by the ‘index patient’.
- Written informed consent
- able to participate in a brief semi-structured interview in person or virtually.
- English speaking or able to undertake interview with support of a health care interpreter.

Inclusion criteria for PATIENT PARTICIPANTS:
- Received the intervention (partial or complete) in the geriatric model of care or comparator groups
- Written informed consent
- able to participate in a brief semi-structured interview in person or virtually.
- English speaking or able to undertake interview with support of a health care interpreter.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Clinicians, patients and carers will be excluded if they don't meet the overall inclusion criteria for their participant category.

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 is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation will be based on clusters, and three clusters will be randomised to commence the intervention at two time points respectively. Randomisation will occur once Human Research Ethics Committee approval is obtained. Randomisation will be managed by the study coordination centre, the University of Technology Sydney.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Stepped wedge cluster randomized trial design: all clusters (cancer services) will begin in the control condition and sequentially transition to the intervention at randomly assigned timepoints. The clusters will transition after 6 months of control data collection. Each cluster contributes to both control and intervention conditions.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the primary outcome, a mixed effects logistic regression with a random effect for cluster and a fixed effect for each step will be fitted. For other data, a generalised linear mixed model will be applied using the appropriate link function and outcome distribution (e.g., a Poisson model for the outcome of hospitalisations).

For the qualitative sub study, the interviews will be audiotaped, transcribed, and analysed using an interpretive descriptive approach considering service and individual characteristics to be explored. Sample size will be informed by data saturation.

A cost effectiveness analysis will be conducted utilising the QLU-C10D as utility instrument (derived from EORTC QLQ-C30). We will also conduct a detailed analysis on the costs of the geriatric oncology care model and its implementation in a given health service and compare these costs to the standard reimbursements that health services would have received from existing funding sources, including payments via the MBS, PBS, private insurance and Commonwealth and State government contributions. This analysis will show if the model is financially sustainable from the perspective of local health service decisions and whether alternative sources of funding are required to meet potential gaps.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/11/2026
Actual
Date of last participant enrolment
Anticipated
28/01/2028
Actual
Date of last data collection
Anticipated
28/02/2029
Actual
Sample size
Target
1080
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 29153 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 29154 0
Westmead Hospital - Westmead
Recruitment hospital [3] 29155 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [4] 29156 0
Eastern Health - Box Hill
Recruitment hospital [5] 29157 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [6] 29768 0
Albury Wodonga Health - Albury campus - Albury
Recruitment hospital [7] 30384 0
Macarthur Cancer Therapy Centre - Campbelltown
Recruitment postcode(s) [1] 45467 0
2170 - Liverpool
Recruitment postcode(s) [2] 45468 0
2145 - Westmead
Recruitment postcode(s) [3] 45469 0
5042 - Bedford Park
Recruitment postcode(s) [4] 45470 0
3128 - Box Hill
Recruitment postcode(s) [5] 45471 0
4029 - Herston
Recruitment postcode(s) [6] 46114 0
2640 - Albury
Recruitment postcode(s) [7] 46801 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 321178 0
Government body
Name [1] 321178 0
Australian Government Department of Health, Disability and Ageing through the Medical Research Future Fund - Clinician Researchers Initiative - 2023 Clinician Researchers: Applied Research in Health Grant Opportunity - Stream 2
Country [1] 321178 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
Country
Australia
Secondary sponsor category [1] 323884 0
None
Name [1] 323884 0
Address [1] 323884 0
Country [1] 323884 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319714 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 319714 0
Ethics committee country [1] 319714 0
Australia
Date submitted for ethics approval [1] 319714 0
Approval date [1] 319714 0
24/10/2025
Ethics approval number [1] 319714 0

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

Contacts
Principal investigator
Name 148150 0
Prof Meera Agar
Address 148150 0
University of Technology Sydney, Level 11, Building 10, 235 Jones Street Broadway NSW 2007
Country 148150 0
Australia
Phone 148150 0
+61 2 9514 4243
Fax 148150 0
Email 148150 0
[email protected]
Contact person for public queries
Name 148151 0
Sharon He
Address 148151 0
University of Technology Sydney, Level 11, Building 10, 235 Jones Street Broadway NSW 2007
Country 148151 0
Australia
Phone 148151 0
+61 2 9514 4243
Fax 148151 0
Email 148151 0
[email protected]
Contact person for scientific queries
Name 148152 0
Meera Agar
Address 148152 0
University of Technology Sydney, Level 11, Building 10, 235 Jones Street Broadway NSW 2007
Country 148152 0
Australia
Phone 148152 0
+61 2 9514 4243
Fax 148152 0
Email 148152 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.