Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001454864
Ethics application status
Approved
Date submitted
24/09/2021
Date registered
25/10/2021
Date last updated
25/10/2021
Date data sharing statement initially provided
25/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of practice nurse coordinated home care package administration model for cancer patients: a pilot randomised controlled trial
Scientific title
The effect of practice nurse coordinated home care package administration model for cancer patients: a pilot randomised controlled trial
Secondary ID [1] 305410 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 323780 0
Condition category
Condition code
Cancer 321292 321292 0 0
Any cancer
Public Health 321500 321500 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the Group One will receive the practice nurse-led home care package administration model of care, which consists of the following components: (1) it will link the home care package provider (the case manager of the patient’s current home care package) with the practice nurse who will be involved in the comprehensive assessment and planning of assistance suitable for the participants; (2) the practice nurse will review the patient’s home care needs through their independent evaluation of the patient in clinic or by phone monthly, or when requested by the patient or the case manager of the patient’s home care package to provide appropriate assistance for new needs detected; (3) the practice nurse will establish coordination mechanisms with the participant’s regular general practitioner or other institutions and professionals according to the patient’s needs; (4) the practice nurse will also organise telehealth with relevant health professionals through telephone proactive follow-up when needed. The intervention components are offered concurrently with ongoing assessment and review, which are planned to continue for 4 months.

Practice nurses will be asked to keep a log about the frequency with which various coordination strategies are used and the perceived effectiveness and satisfaction with the strategies. Specifically, the log will keep a record of number of contacts with the patients or their home care providers, duration of each contact, concerns discussed, and advice provided; time spent on liaising with patients’ general practitioners and allied health professionals; and other issues arising from the intervention. The log will help check on compliance with the study protocols, as well as the feasibility of the intervention.
Intervention code [1] 321818 0
Treatment: Other
Comparator / control treatment
Participants in Group Two will receive usual Level 3 or Level 4 assistance from their chosen home care package provider.

A home care package is a subsidy provided by the Australian Government to an approved provider of home care to coordinate a package of care, services and case management to meet the individual needs of older Australians (over 65 years). Individuals are assessed by a professional assessor using a nationally consistent assessment framework for four levels of support, from Level 1 of basic care needs to Level 4 of high care needs. Leve 3 home care package is to care for those with intermediate care needs, offering $34,550 a year. level 4 is to care for those with high care needs, offering $52,377.50 a year.
Control group
Active

Outcomes
Primary outcome [1] 329073 0
The primary outcome of this pilot study is to assess the feasibility of a practice nurse-led home care package administration to improve cancer patients’ functional status, health-related quality of life, experiences of care and health service utilization.

Assessment of feasibility includes:
• Recruitment issues such as consent rate and attrition rate. Consent rate is determined from study logs. Every time a patient dropped out of study, it will be recorded on study logs as well as the reasons. So that attrition rate and reasons can be determined.
• Acceptability of the proposed outcome measures and data collection procedures. These will be determined from study-specific surveys, as well as nursing logs.
• Acceptability of the intervention to all participants from patients’ questionnaires and nursing log kept by practice nurses delivering the intervention.
Timepoint [1] 329073 0
4 months following the intervention
Secondary outcome [1] 401348 0
Functional status

It is primarily assessed based on ability to perform activities of daily living (ADL) and instrumental activities of daily living (IADL). Sixteen measures on the Outcome and Assessment Information Set (OASIS) instrument are selected to represent patients’ functional status. These include 15 ADL and IADL plus one additional measure – frequency of pain interfering with functioning.
Timepoint [1] 401348 0
4 months following intervention
Secondary outcome [2] 401349 0
Quality of life, using The Functional Assessment of Cancer Therapy – General (FACT-G v. 4).
Timepoint [2] 401349 0
4 months following intervention
Secondary outcome [3] 401350 0
Patient experience of care, measured by using Consumer Assessment of Healthcare Providers Systems (CAHPS) surveys.
Timepoint [3] 401350 0
4 months following intervention

Eligibility
Key inclusion criteria
Patients will be eligible for the study if they:
(1) receive a Level 3 or Level 4 Home Care Package
(2) have a past or current cancer diagnosis
(3) live within 20km radius of the enrolled general practice
(4) are able to understand and give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Institutionalisation or change of residence to an area not covered by the study
(2) Hospitalisation for longer than seven days in the month prior to the intervention period, except for terminally ill patients who are readmitted for disease stabilisation and symptom control, as part of their usual process of care. This criterion is established in order to avoid the influence of hospitalisation interventions on outcomes
(3) Cognitively impaired or highly dependent on medical care who are unable to give consent
(4) Patient’s nominated home care provider declines to participate.

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)
.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
29/10/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 309772 0
Charities/Societies/Foundations
Name [1] 309772 0
Rosemary Bryant Foundation
Country [1] 309772 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Rosemary Bryant Foundation
Address
191 Torrens Road
Ridleyton SA 5008
Country
Australia
Secondary sponsor category [1] 310802 0
None
Name [1] 310802 0
Address [1] 310802 0
Country [1] 310802 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309515 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [1] 309515 0
Victoria Park Rd
Kelvin Grove, QLD 4059
Ethics committee country [1] 309515 0
Australia
Date submitted for ethics approval [1] 309515 0
Approval date [1] 309515 0
03/09/2021
Ethics approval number [1] 309515 0

Summary
Brief summary
Cancer patients/survivors have complex care needs beyond daily living assistance. They need a range of medical and allied health services as well as support for their daily living.

The purpose of the study is to implement a pilot intervention of a practice nurse-led home care package administration aiming to improve your functional status, health-related quality of life, experiences of care and health service utilization.

Who is it for?
You may be eligible for this study if you have have cancer have previously had cancer and are receiving home care services.

Study details
All participants have equal chances to be allocated to Group One or Two. Group One will receive additional support and ongoing monitoring from a practice nurse. Group Two will continue to receive home care services as usual. Both groups will continue with usual medical and nursing care.

It is hoped that this study will help determine whether additional support is beneficial to those who have cancer or have survived cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114418 0
Dr Isabella Zhao
Address 114418 0
Queensland University of Technology, 60 Musk Ave, Kelvin Grove, QLD 4059
Country 114418 0
Australia
Phone 114418 0
+61 7 31380466
Fax 114418 0
Email 114418 0
[email protected]
Contact person for public queries
Name 114419 0
Dr Isabella Zhao
Address 114419 0
Queensland University of Technology, 60 Musk Ave, Kelvin Grove, QLD 4059
Country 114419 0
Australia
Phone 114419 0
+61 7 31380466
Fax 114419 0
Email 114419 0
[email protected]
Contact person for scientific queries
Name 114420 0
Dr Isabella Zhao
Address 114420 0
Queensland University of Technology, 60 Musk Ave, Kelvin Grove, QLD 4059
Country 114420 0
Australia
Phone 114420 0
+61 7 31380466
Fax 114420 0
Email 114420 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


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.