Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001325796
Ethics application status
Approved
Date submitted
3/10/2022
Date registered
12/10/2022
Date last updated
28/03/2024
Date data sharing statement initially provided
12/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The CareNET trial: Caring for carers of people with advaNced cancer at hospiTal discharge
Scientific title
Caring for carers of people with advaNced cancer at hospiTal discharge (CareNET): A single-arm open label feasibility study.
Secondary ID [1] 308089 0
None
Universal Trial Number (UTN)
None
Trial acronym
CareNET (Caring for carers of people with advaNced cancer at hospiTal discharge )
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 327781 0
Carers needs 327782 0
Discharge planning 327785 0
Condition category
Condition code
Cancer 324853 324853 0 0
Any cancer
Physical Medicine / Rehabilitation 324854 324854 0 0
Occupational therapy
Public Health 324855 324855 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
What:
Materials:
The Carer Support Needs Assessment Tool - Intervention (CSNAT-I) tool will be used. This is a licensed tool that can be found at www.csnat.org. It consists of 14 domains of need for carer of people with palliative care needs. It is part of the CSNAT-I – a five stage carer-led, clinician facilitated intervention that was developed in the UK and has been validated with community-based carers for people with advanced cancer. This paper-based form is a record that carers can keep and clinicians’ document summary in the electronic medical record. Online learning modules were used to train intervention providers and can be found at the website once license is approved. A local protocol was developed and will be used to assist with intervention delivery and documentation into electronic medical record.

Procedures:
The intervention includes identification and prioritisation of needs (Stages 1-3); Development of action plan for prioritised needs (Stage 4); and review of whether needs have been addressed; and structured handover of outstanding needs (Stage 5).
Needs Assessment
After the Occupational Therapist (OT) has completed an initial assessment with patients to determine their needs related to achieving discharge home (e.g., functional limitations, physical care needs, QOL of goals); they meet with the carer to identify and prioritise their discharge needs using the CSNAT-I paper based tool (Stages 1-3). This can occur face to face, via telehealth or the phone depending on carer preference and access. The assessment process involves carers being provided with the 14 domains of need, self-rating how much support they think they need and describing how the need relates to them. For example, the domain “needing help with equipment” may relate to a carer wanting to know how to use a manual lifting device. The carer will then choose three needs they have described that they wish to prioritise and seek support with before discharge home.
Responding to needs:
The OT identifies with the carer what actions are required to address prioritised needs (Following Stage 4 of CSNAT-I). Actions that need to be communicated to the patient and team is determined between OT and carer at this stage. Actions may be direct OT intervention, referrals to other disciplines and providers; signposted for carers to address themselves or self-directed exclusively by the carer. These are documented on the CSNAT-I which both the carer and OT keep copies of. The OT actions the relevant items within the required time. A pre-discharge review will occur if needed by carer e.g., to check they have all the equipment delivered to their house. Proposed and enacted action plans are communicated to the patient and team members as required.
Review:
Prior to discharge the OT will ask the carer to nominate the preferred method and time of review required after discharge. Options will be (1) treating OT to phone at time proposed by carer; (2) other key contact identified by carer (social worker, nurse coordinator) or (3) carer contacts treating OT or key contact person at preferred time.
Shared review (Stage 5 CSNAT-I) will involve (1) checking if action plan has been completed, and (2) addressing outstanding or new needs identified by or referring to relevant service providers (e.g., GP, community palliative care service, nurse coordinators).


Who:
Trained occupational therapists will facilitate the delivery of the CSNAT-I aspect of the intervention. Multi-disciplinary interventions will be delivered (in response to CSNAT-I) based on individual need.
How:
Stages 1 to 4 will be delivered face to face, telehealth or via phone; Stage 5 will be telehealth or via phone. It will occur between the OT and the carer for the patient.
Where:
Stages 1-4 will occur during acute admission and Stage 5 will occur once the patient has been discharged from the acute hospital. Treating occupational therapists delivering the intervention will be based in the hospital however there may be circumstances where they are conducting a home visit.
When and how much:
Stages 1-4 during hospital stay and when discharge home has been decided. Stage 5 within 72 hours after discharge (or other times nominated by carer, but no more than 1 week after discharge). Stage 1-4 can occur as separate or combined contacts between OT and carer. It is anticipated that stages 1-4 will take between 20-40 minutes; and stage 5 between 5 -20 minutes. However this will depend on individual needs and whether it is occurring within other bundles of care e.g. psychoeducation.
If the person with advanced cancer has a change in planned discharge destination, anticipated care needs, length of stay in hospital; different stages of the intervention can be repeated
Tailoring
A person-centred model means actions and care generated from the intervention and how it is delivered is individualised and based on personal needs.

Strategies used to monitor adherence will include: record of participation rates, outputs from intervention and completion of tool; check points for clinicians to ensure fidelity and completion rates.
Intervention code [1] 324540 0
Treatment: Other
Comparator / control treatment
No control group -single arm trial.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332671 0
Feasibility Co-primary outcomes:
Recruitment - total no.of participants recruited per month
Measures/endpoints: Quantitative
Recruitment rates per month via project specific eCRF.
Timepoint [1] 332671 0
Data collected during 9 months recruitment window.
Primary outcome [2] 332672 0
Feasibility: Co-primary outcome:
Adherence to the intervention

Measures/endpoints: Quantitative
Completion rates per participant and across study via project specific eCRF
Timepoint [2] 332672 0
Measures would be taken within 1 weeks after discharge, post intervention/final shared review period (T3).
Secondary outcome [1] 414329 0
Secondary feasibility outcomes:(These will be analysed as a composite outcome)
Process factors - Describing the population by key eligibility criteria, reasons for non-recruitment and early withdrawal.
Measures/Endpoints: Quantitative
Recruitment rate and eligibility data (including reasons for non-recruitment and withdrawal) via screening log and project specific eCRF

Qualitative
Clinician interviews will be used to collect data on their views on the feasibility of the intervention content, delivery and study conduct; specifically their views on the enablers and barriers influencing the feasibility. Interviews will be semi-structured, individual face-to-face or phone-based interviews with a member of the research team.
Timepoint [1] 414329 0
Recruitment rate and eligibility data (including reasons for non-recruitment and withdrawal) during study period.
Clinician interviews will be conducted at 7 month post accrual period
Secondary outcome [2] 414330 0
Secondary feasibility outcomes: Resource factors - Resources, costs and burden of study measures incurred by patient, carer, clinician. These will be analysed as composite outcomes.
Measures/Endpoints:
Patient and carer time and costs incurred per intervention, via project-specific survey post intervention period.
Clinician time and costs via medical record and clinical activity reports post intervention period/final shared review stage (T3).

Patient, carer, and clinician views on intervention and study burden via interviews post intervention/final shared review stage (T3) Patient and carer interviews will be phone-based, and clinician will be face to face or phone - all with a member of the research ream
Timepoint [2] 414330 0
Clinician time and cost measures will be collected within 1 week after discharge, post intervention/final shared review (T3)
Patient and carer survey on costs incurred and semi-structured interviews will be collected within 1 week after discharge, post intervention/final shared review (T3)
Health utilisation costs (30 day readmissions) will be collected at 1 month after discharge (T4).

Secondary outcome [3] 414331 0
Secondary feasibility outcome: Management factors: Data and participant management issues required to inform the feasibility of study design and conduct for a larger Phase III implementation/effectiveness trial.
All measures will be assessed as a composite secondary outcome.
Measures: Quantitative
Service and process data via project specific eCRF
Variances in patient and carer-related measures (to power for larger study) via validated assessments. Carer related measures are: Carer QOL - 7D, Carer preparedness,. Patient related measures are: Australian Karnofsky Performance Scale (AKPS), Resource Utilisation Group - Activities of Daily Living (RUG-ADL), Symptom Assessment Scale, Quality of Life (EQ5D).

Qualitative
Clinician individual semi-structured interviews will be conducted face to face or via phone with a member of the research team
Timepoint [3] 414331 0
Service and process data post intervention period
Variances in patient and carer-related measures (to power for larger study) across 3 time points - 1-7 days before intervention starts during admission (T1), after stages 1-4 of intervention and within 1-2 days of discharge (T2); and 1 week after discharge and post intervention/shared review stage (T3).

Clinician interviews will be collected at 7 months post accrual period.

Eligibility
Key inclusion criteria
Carer participants must meet the inclusion criteria in order for patient participants to be included.
Carer inclusion criteria
• Must identify as carer. This study will refer to a carer as “Lay people in a close supportive role who share in the illness experience of the patient and who undertake vital care work and emotion management” (2)
• Able to provide informed consent
• English speaking and able to read at 5th grade level

Patient inclusion criteria
- Diagnosis of advanced cancer
- Must have a person (family member or friend) that identifies as their carer
- Planned discharge home
- English-speaking
- Able to provide informed consent or person consenting on participants behalf (authorized representative) *
*Patients providing own consent will complete all measures, patients consenting via authorised representative will not complete self-rating measures (Quality of Life (EQSD)and Survey on costs)


Clinician inclusion criteria
• Occupational therapist delivering the intervention during the trial.

Process for identifying an authorised representative for patient
If the participant is not able to provide consent, the authorised representative will be identified and approached for consent to participate. As defined by the Health Records Act – Section 85, the authorised representative (the individual who can make decisions regarding consent to use and disclose health information) can be one of the following:

a. A guardian of the individual; or
b. An attorney for the individual under an enduring power of attorney; or
c. The individual medical treatment decision maker within the meaning of the Medical Treatment Planning and Decisions Act 2016; or
d. An administrator within the meaning of the Guardianship and Administration Act 2019; or
e. A parent of the individual if the individual is a child; or
f. Otherwise empowered under law to perform duties or exercise powers in the best interests of the individual
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who meet any of the following criteria will be excluded from study entry:
Patient exclusion criteria
- Planned discharge to residential care or subacute.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
A single arm open label study design will be conducted to determine the feasibility of the CareNET intervention and the study design.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical Analysis: Descriptive statistics will be examined for the quantitative data; the mean and SD for continuous measures and the frequency and percentage for categorical measures will be calculated overall and subgroups. The primary feasibility outcomes, the recruitment, will be summarised with rate and the retention with the proportion. CIs will be also calculated to reflect the uncertainty of the feasibility outcomes.
Variances will be estimated for the patient and carer-related measures (i.e., functional performance, quality of life, and carer preparedness) and their respective CIs to aid in the future power calculation. The estimated variances will be used to form a range of estimates around that value in sensitivity analyses. The main aim of this study is to determine the feasibility of study parameters, including the timing of the assessment. Given we suspect changes from our outcomes at discharge from the baseline, we sought to examine the feasibility of measuring at discharge (T2). For future power calculation, one way repeated measures analysis will be used to evaluate the variances of the repeated measures and their correlation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/10/2022
Actual
16/11/2022
Date of last participant enrolment
Anticipated
26/06/2023
Actual
29/06/2023
Date of last data collection
Anticipated
24/07/2023
Actual
6/07/2023
Sample size
Target
20
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23277 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 38648 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 312346 0
Charities/Societies/Foundations
Name [1] 312346 0
Peter Mac Foundation
Country [1] 312346 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Grattan Street
Melbourne Vic 3000
Country
Australia
Secondary sponsor category [1] 313908 0
University
Name [1] 313908 0
University of Technology Sydney
Address [1] 313908 0
15 Broadway, Ultimo NSW 2007
Country [1] 313908 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311709 0
Peter Mac Ethics Committee
Ethics committee address [1] 311709 0
Ethics committee country [1] 311709 0
Australia
Date submitted for ethics approval [1] 311709 0
09/03/2022
Approval date [1] 311709 0
01/08/2022
Ethics approval number [1] 311709 0
HREC/83438/PMCC

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

Contacts
Principal investigator
Name 122082 0
Ms Celia Marston
Address 122082 0
Peter MacCallum Cancer Centre
Grattan Street
Melbourne Vic 3000
Country 122082 0
Australia
Phone 122082 0
+61418915883
Fax 122082 0
Email 122082 0
[email protected]
Contact person for public queries
Name 122083 0
Celia Marston
Address 122083 0
Peter MacCallum Cancer Centre
Grattan Street
Melbourne Vic 3000
Country 122083 0
Australia
Phone 122083 0
+61418915883
Fax 122083 0
Email 122083 0
[email protected]
Contact person for scientific queries
Name 122084 0
Celia Marston
Address 122084 0
Peter MacCallum Cancer Centre
Grattan Street
Melbourne Vic 3000
Country 122084 0
Australia
Phone 122084 0
+61418915883
Fax 122084 0
Email 122084 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
This is health-services research evaluating the feasibility of the intervention - individual participant data does not need to be made available.


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.