Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000429651p
Ethics application status
Submitted, not yet approved
Date submitted
21/02/2023
Date registered
28/04/2023
Date last updated
28/04/2023
Date data sharing statement initially provided
28/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the impact of a Neuro-Oncology nurse home visiting service in the management of patients with glioblastoma
Scientific title
Investigating the impact of a Neuro-Oncology nurse home visiting service on the well-being of patients with glioblastoma and on the need for hospital attendance.
Secondary ID [1] 309047 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioblastoma 329102 0
Condition category
Condition code
Cancer 326076 326076 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will examine the effect of having brain tumour nurses visit patients with glioblastoma and their carers at home.

The home visits will commence after the patient has been informed of their biopsy results and treatment plan. The visits will initially occur every 2 to 4 weeks, but as the patient's illness progresses and as the needs of the patients and their carers increase, the nurses may visit the patient two to three times a week. Each visit is for approximately one hour. The duration may be longer depending on the patient’s needs. At each visit (or when a phone call is made to the nurses by the patient or their carer) their needs will be assessed to determine the appropriate frequency of nursing visits. The home visits will be done for the duration of the study (18 months from commencement of the study).

The nurses provide supportive care, assessment, monitoring, intervention and care planning. They will liaise with the occupational therapist concerning the patient’s needs, for example, requiring equipment from the Cabrini Neuro-Oncology equipment bank.

The patient’s and carers’ adherence to the intervention initiated by the nurses will be monitored at the next nursing visit and their next outpatient clinic appointment.

The occupational therapists will visit if the nurses assess that there are safety issues at home arising from their neurological or cognitive deficits. Their visits are for approximately one hour. The frequency of visits will depend on the needs of the patients, but typically they will visit on only one occasion. The patient’s and carers’ adherence to the intervention initiated by the occupational therapist will be monitored at the next nursing visit and their next outpatient clinic appointment.
Intervention code [1] 325489 0
Treatment: Other
Comparator / control treatment
The comparator group will be a group of patients with glioblastoma who will not have the brain tumour nurses or occupational therapists visit them at home. They will not have access to the Cabrini Neuro-Oncology equipment bank.
Control group
Active

Outcomes
Primary outcome [1] 333941 0
30-day readmission rates. This data will be collected prospectively when patients are seen in clinic, and also by a review of their medical record.
Timepoint [1] 333941 0
30 days after discharge
Primary outcome [2] 333942 0
Number of visits to the emergency departement. This data will be collected prospectively when patients are seen in clinic, and also by a review of their medical record.
Timepoint [2] 333942 0
At completion of study (18 months after commencement of study)
Primary outcome [3] 333944 0
Qualitative one on one face to face interviews with patients and their carers performed by a member of the research team. Questions to be asked may include: a description about their brain tumour journey; how they feel about the level of care they have received in regards of their medical needs; to discuss their experiences with the nurses and the level of care they have received from them; their thoughts about having the nurses come into their home for care; any aspects of their care that they think could be improved.
Timepoint [3] 333944 0
These will be done at the completion of radiotherapy and chemotherapy, then every 6 months thereafter, up to a maximum of 18 months after commencement of the study.
Secondary outcome [1] 418806 0
Patient reported outcome measures - assessed using EORTC QLQ-30
Timepoint [1] 418806 0
After completion of radiotherapy and chemotherapy, and then every 3 months thereafter, up to a maximum of 18 months after commencement of the study.
Secondary outcome [2] 418807 0
Total bed days in the acute hospital. This data will be collected prospectively when patients are seen in clinic, and also by a review of their medical record.
Timepoint [2] 418807 0
18 months after commencement of the study.
Secondary outcome [3] 418808 0
Whether the patient dies at home, in hospital or in a palliative care facility. This data will be collected prospectively by the Neuro-Oncology nurses or Neuro-Oncologist looking after the patients, and also by a review of their medical record.
Timepoint [3] 418808 0
at completion of study (18 months after commencement of study)
Secondary outcome [4] 419280 0
Patient reported outcome measures - assessed using EORTC QLQ-BN20
Timepoint [4] 419280 0
After completion of radiotherapy and chemotherapy, and then every 3 months thereafter, up to a maximum of 18 months after commencement of the study.
Secondary outcome [5] 419281 0
Total number of hospitalisations following discharge after initial surgery. This data will be collected prospectively when patients are seen in clinic, and also by a review of their medical record.
Timepoint [5] 419281 0
18 months after commencement of the study.
Secondary outcome [6] 419282 0
Qualitative one on one face to face interviews with the Neuro-Oncologist looking after the patients, performed by a member of the research team. They will be asked their perception of whether there is any difference in the management and outcomes of patients with glioblastoma who have had the Neuro-Oncology nurses visit them at home.
Timepoint [6] 419282 0
To be done at the completion of the study
Secondary outcome [7] 419283 0
Qualitative one on one face to face interviews with the hospital based Neuro-Oncology nurse, performed by a member of the research team. They will be asked their perception of whether there is any difference in the management and outcomes of patients with glioblastoma who have had the Neuro-Oncology nurses visit them at home.
Timepoint [7] 419283 0
To be done at the completion of the study

Eligibility
Key inclusion criteria
patients with a newly diagnosed glioblastoma who are well enough to undergo standard treatment of combined radiotherapy and chemotherapy
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients who are not well enough to undergo standard treatment of combined radiotherapy and chemotherapy

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 will involve contacting the holder of the allocation schedular
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The number of patients to be recruited has been determined by the number of patients who are usually diagnosed with a glioblastoma in the 18 month period that the study will be running.
The qualitative data will be analysed by researchers experienced in this area.
The quantitative data is unlikely to reach statistical significance given the patient numbers involved, but will provide some indication of the benefit or otherwise of the brain tumour nurses visiting the patients at home.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
Date of last participant enrolment
Anticipated
31/05/2024
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24081 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 39590 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 313250 0
Charities/Societies/Foundations
Name [1] 313250 0
Cabrini Insititute - fundraising initiative
Country [1] 313250 0
Australia
Primary sponsor type
Hospital
Name
Monash Medical Centre
Address
Monash Medical Centre, 246 Clayton Rd, Clayton, VIC, 3168
Country
Australia
Secondary sponsor category [1] 314982 0
None
Name [1] 314982 0
Address [1] 314982 0
Country [1] 314982 0
Other collaborator category [1] 282568 0
Hospital
Name [1] 282568 0
Cabrini Health
Address [1] 282568 0
Level 2, 154 Wattletree Rd, Malvern, VIC, 3144
Country [1] 282568 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312483 0
Monash Health
Ethics committee address [1] 312483 0
246 Clayton Rd, Clayton, VIC, 3168
Ethics committee country [1] 312483 0
Australia
Date submitted for ethics approval [1] 312483 0
17/01/2023
Approval date [1] 312483 0
Ethics approval number [1] 312483 0

Summary
Brief summary
Patients with glioblastoma have particular needs that distinguish them from other patients with cancer, as they also have neurological issues that can affect them physically, cognitively and psychologically. This in turn produces significant burdens on their carers.
The aim of this study is to assess the effect of having brain tumour nurses visit patients at home.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with a glioblastoma, and you are well enough to undergo combined radiotherapy and chemotherapy treatment.

Study details
Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. Participants who are allocated to the first group will have brain tumour nurses visit them at home every 2-4 weeks. This may increase over time as the needs of participants and their carers change. During the at home visits, nurses will assess the participant and carers needs and act as a point of contact to address any issues that may arise. Occupational therapists will assist in assessing the needs of these patients and providing the necessary equipment to enable them to remain safely at home.
Participants who are allocated to the second group will continue to receive their usual care from their oncologist but will not receive at home visits from a brain tumour nurse or occupational therapist. These participants will be able to request additional assistance and equipment from the hospital if needed, but they will not have any at home visits as part of their involvement in the study. Participants in both groups will be asked to fill in forms to assess their symptoms. Participants who have the nurses visit them at home will be asked to attend one-on-one interviews with a member of the research team to provide their feedback on the care they have received.

It is hoped this research will show whether providing at home care options to patients with glioblastoma has a positive impact upon their quality of life and reduces the need for hospital admission compared to usual care practices. If this study does show a positive impact of the at home visits, a larger trial involving a greater number of glioblastoma patients may be undertaken to further investigate this method of care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124818 0
Dr Ronnie Freilich
Address 124818 0
Neurology Department, Monash Medical Centre, 246 Clayton Rd, Clayton, VIC, 3168
Country 124818 0
Australia
Phone 124818 0
+61 0419365626
Fax 124818 0
Email 124818 0
ronnie.freilich@monashhealth.org
Contact person for public queries
Name 124819 0
Dr Ronnie Freilich
Address 124819 0
Neurology Department, Monash Medical Centre, 246 Clayton Rd, Clayton, VIC, 3168
Country 124819 0
Australia
Phone 124819 0
+61 395942240
Fax 124819 0
Email 124819 0
ronnie.freilich@monashhealth.org
Contact person for scientific queries
Name 124820 0
Dr Ronnie Freilich
Address 124820 0
Neurology Department, Monash Medical Centre, 246 Clayton Rd, Clayton, VIC, 3168
Country 124820 0
Australia
Phone 124820 0
+61 0419365626
Fax 124820 0
Email 124820 0
ronnie.freilich@monashhealth.org

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.