Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001488796p
Ethics application status
Submitted, not yet approved
Date submitted
8/11/2022
Date registered
28/11/2022
Date last updated
28/11/2022
Date data sharing statement initially provided
28/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Does early referral to an allied health professional improve the quality of life of people diagnosed with brain cancer?
Scientific title
Can early referral to allied health impact on hospital admissions and quality of life after diagnosis of high grade glioma?
Secondary ID [1] 308016 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High grade glioma 327691 0
Quality of life 327694 0
Condition category
Condition code
Cancer 324774 324774 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Early allied health referral for patients diagnosed with High Grade Glioma (HGG)

Patients will be referred for early allied health intervention by the treating oncology team (nursing or medical staff) within 6-8 weeks of their first oncology appointment. Patients, with or without a carer, aged 18 years or older diagnosed with HGG (including Grade III anaplastic, astrocytomas, Grade IV oligodendrogliomas and glioblastoma]) within the past three months will be eligible for the early service.

Within two weeks of receipt of referral a senior occupational therapist or senior social worker will make initial contact with patients or carers, either in the outpatient oncology clinic (if they are present) or via phone to schedule an initial therapy appointment. This appointment will take place in either outpatient cancer clinic, inpatient hospital ward, phone consultation or patient’s home. Patients needs will be determined and subsequent appointments will be made dependent on their needs. Both initial and subsequent appointments will either be face to face or via virtual care and will vary in length from 30-90 minutes. Data collection will occur over a six-month period however therapy treatment will continue after this time dependent on the patient’s needs.

The allied health service aims to improve symptoms, maximising functional independence and participation by using a holistic biopsychosocial model (covering physical and psychosocial aspects) of care, as defined by The International Classification of Functioning, Disability and Health (ICF). Standard interventions that are provided by the occupational therapist and social worker in the oncology service include provision of equipment, assessment and referral for home services, NDIS application support, case coordination and patient and carer education.

Patient’s performance will be measured with the Karnofsky Performance Status (KPS) scale and function will be measured using the Functional Independence Measure (FIM), pre and post intervention.

Patients and carers will also complete:
• The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30) and the EORTC brain cancer module (EORTC QLQ-BN20) will be used to measure patients’ perception of their QOL and symptom burden.
• Caregiver Quality of Life Index-Cancer (CQOLC) questionnaire will evaluate caregiver’s well-being and QOL.

The patient and carer questionnaire will be completed pre and post intervention i.e. on recruitment and then after 6-months. These questionnaires will be completed during clinic appointments or over the phone if necessary.
Intervention code [1] 324470 0
Treatment: Other
Intervention code [2] 324471 0
Prevention
Comparator / control treatment
A retrospective audit will be completed to establish the outcome measures for a case-matched control group. These patients will have been provided with standard allied health care consisting of adhoc referral, assessment and intervention at hospital admission between March 2020 until March 2021. Data from the six month period after diagnosis will be collected from Sir Charles Gairdner Hospital medical records.
Control group
Historical

Outcomes
Primary outcome [1] 332605 0
Unplanned healthcare use in the 6-months after intervention including average length of stay per hospital admission (total LOS/number of admissions) - composite primary outcome. Information will be sourced from hospital data systems, including WebPAS and i-SOFT.
Timepoint [1] 332605 0
6-months post receipt of referral to allied health
Secondary outcome [1] 414030 0
Total number of days in hospital. Information will be sourced from hospital data systems, including WebPAS and i-SOFT, and medical records
Timepoint [1] 414030 0
6-months from receipt of referral to allied health
Secondary outcome [2] 414031 0
Number of ED presentations and hospital admissions over the 6-month follow-up period. Information will be sourced from hospital data systems, including WebPAS and i-SOFT.
Timepoint [2] 414031 0
6-months from receipt of referral to allied health
Secondary outcome [3] 414032 0
Total number of days remaining in hospital after being medically cleared for discharge due to lack of home resources (i.e. equipment, services). Information will be sourced from medical record audit.
Timepoint [3] 414032 0
6-months from receipt of referral to allied health
Secondary outcome [4] 414033 0
Time from diagnosis to receipt of allied health input. Information will be sourced from medical record audit.
Timepoint [4] 414033 0
6-months from receipt of referral to allied health
Secondary outcome [5] 414034 0
Total occasions of service received from occupational therapy for inpatient and outpatient services. Information will be sourced from Allied Health Statistics (AHS).
Timepoint [5] 414034 0
6-months from receipt of referral to allied health
Secondary outcome [6] 414035 0
Time from diagnosis to care service approval i.e. National Disability Insurance Scheme (NDIS) or My Aged Care approval with associated access to appropriate home care supports and services. Information will be sourced from medical records.
Timepoint [6] 414035 0
6-months from receipt of referral to allied health
Secondary outcome [7] 415949 0
Total occasions of service received from social work for inpatient and outpatient services. Information will be sourced from Allied Health Statistics (AHS).
Timepoint [7] 415949 0
6-months from receipt of referral to allied health

Eligibility
Key inclusion criteria
Dyads consisting of patients, and their carer, will be eligible if they are aged 18 years or older and the patient is diagnosed with HGG (including Grade III anaplastic astrocytomas, Grade III oligodendrogliomas and glioblastoma]) within the past three months.

Patients without a carer will still be eligible for inclusion.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient or carers who are unable to provide informed consent to participate in the study.

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
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
5/12/2022
Actual
Date of last participant enrolment
Anticipated
27/02/2023
Actual
Date of last data collection
Anticipated
31/07/2023
Actual
Sample size
Target
124
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 23182 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 38548 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 312277 0
Hospital
Name [1] 312277 0
Sir Charles Gairdner Hospital
Country [1] 312277 0
Australia
Primary sponsor type
Individual
Name
Dr Kristie Harper
Address
Occupational Therapy Department
G Block
Lower Ground Floor
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands, WA, 6009
Country
Australia
Secondary sponsor category [1] 313821 0
Individual
Name [1] 313821 0
Ms Brooke Russell
Address [1] 313821 0
Occupational Therapy Department
G Block
Lower Ground Floor
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands, WA, 6009
Country [1] 313821 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311650 0
Sir Charles Gairdner and Osborne Park Healthcare Group Human Research Ethics Committee
Ethics committee address [1] 311650 0
Ethics committee country [1] 311650 0
Australia
Date submitted for ethics approval [1] 311650 0
23/09/2022
Approval date [1] 311650 0
Ethics approval number [1] 311650 0

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

Contacts
Principal investigator
Name 121854 0
Ms Brooke Russell
Address 121854 0
Occupational Therapy Department
G Block
Lower Ground Floor
Sir Charles Gairdner Hospital
Hospital Avenue
Nedland, WA, 6009
Country 121854 0
Australia
Phone 121854 0
+61 8 64572855
Fax 121854 0
Email 121854 0
[email protected]
Contact person for public queries
Name 121855 0
Brooke Russell
Address 121855 0
Occupational Therapy Department
G Block
Lower Ground Floor
Sir Charles Gairdner Hospital
Hospital Avenue
Nedland, WA, 6009
Country 121855 0
Australia
Phone 121855 0
+61 8 64572855
Fax 121855 0
Email 121855 0
[email protected]
Contact person for scientific queries
Name 121856 0
Kristie Harper
Address 121856 0
Occupational Therapy Department
G Block
Lower Ground Floor
Sir Charles Gairdner Hospital
Hospital Avenue
Nedland, WA, 6009
Country 121856 0
Australia
Phone 121856 0
+61 8 64572855
Fax 121856 0
Email 121856 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.