Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001147875
Ethics application status
Approved
Date submitted
24/10/2012
Date registered
30/10/2012
Date last updated
22/09/2024
Date data sharing statement initially provided
22/09/2024
Date results provided
22/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Caregiver Intervention and Support for carers of people with brain tumours.
Scientific title
A randomised controlled trial of a supportive educational intervention for caregivers of patients with high grade glioma (Care-IS).
Secondary ID [1] 281435 0
None
Universal Trial Number (UTN)
U1111-1136-3146
Trial acronym
Care-IS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Experience of Caregiving 287686 0
Quality of life of caregivers 287687 0
Anxiety and Depression amongst caregivers 287688 0
Preparedness to care 287689 0
Competency to care 287690 0
Caregiver strain 287691 0
Unmet needs of caregivers of brain tumour patients 287692 0
Condition category
Condition code
Other 288031 288031 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Intervention is a supportive educational intervention for caregivers. It will be in four parts and delivered in a sequential manner:
1. An initial telephone assessment of current unmet needs of the caregiver by research nurse. This should take 20 minutes.
2. 7-14 days later there will be a single home visit where the research nurse will provide support and education around the issues that have arisen in the telephone assessment and baseline survey of unmet need. The research nurse will also deliver the information folder specified below. It is expected that these home visits may take 60-90 minutes.
3. Caregivers will be given a tabbed supportive and educational information resource file which is specifically tailored for the caregiver as appropriate for their identified unmet needs. New information will be provided to the caregiver to place in the folder if new unmet needs are identified.
4. Ongoing monthly telephone support and assessment of new needs as they arise. These will commence a month after the delivery of the intervention. These telephone assesments should take about 10 minutes unless prolonged by the participants.
Intervention code [1] 285938 0
Treatment: Other
Comparator / control treatment
The control group will receive current usual care which is information that is currently freely available and some access to a cancer nurse coordinator with no specific tailoring or extra support.
Control group
Active

Outcomes
Primary outcome [1] 288237 0
Experience of caregiving (as measured on the either the preparedness to care, caregiver competence or caregiver strain index - whichever is identified as being most informative in the pilot study). The other tools will be relegated to secondary outcomes if they are feasible.
Timepoint [1] 288237 0
Timepoints: baseline, 6 weeks, 3, 6, 9 and 12 months for full assessment Monthly assessment of health care utilisation will be carried out over the telephone
Secondary outcome [1] 299673 0
Caregiver Quality of life - cancer scale
Timepoint [1] 299673 0
Baseline, 6 weeks, 3, 6, 9 and 12 months
Secondary outcome [2] 299674 0
Caregiver Unmet Needs ( Partner and Caregiver Supportive Care Needs Scale or Brain Tumour Specific Supportive Care needs for Carers survey - whichever is identified in the pilot as being most informative)
Timepoint [2] 299674 0
Measured at baseline, 6 weeks, 3, 6, 9 and 12 months
Secondary outcome [3] 299675 0
Caregiver anxiety and Depression (Hospital anxiety and depression scale)
Timepoint [3] 299675 0
Measured at baseline, 6 weeks, 3, 6, 9 and 12 months
Secondary outcome [4] 299676 0
Distress thermometer
Timepoint [4] 299676 0
Measured at baseline, 6 weeks, 3, 6, 9 and 12 months
Secondary outcome [5] 299677 0
Health care utilisation checklist
Timepoint [5] 299677 0
Monthly for 12 months in the monthly nurse led phone assessment.
Secondary outcome [6] 299689 0
EQ-5D 3L as measured by care-reciepient once at baseline and proxy measures collected at all time points
Timepoint [6] 299689 0
This will be self rated once by the care-recipient at baseline.
The caregiver will provide ongoing proxy ratings at baseline, 6 weeks post intervention and at 3, 6, and 12 months.
Secondary outcome [7] 299703 0
Patient Karnofsky score as rated by nurse and caregiver
Timepoint [7] 299703 0
Monthly for 12 months in the monthly nurse led phone assessment.
Secondary outcome [8] 304880 0
General Health Questionnaire (GHQ-12)
Timepoint [8] 304880 0
Measured at baseline, 6 weeks, 3, 6, 9 and 12 months

Eligibility
Key inclusion criteria
Primary caregivers of patients with High Grade Glioma
Aged 18 and over
Fully competent, independent individuals with no mental, cognitive or functional disability and willing to comply with study guidelines.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No concealment procedures.
All participants are informed upfront that this is a randomised trial.
Participants will be identified by clinical staff at neurosurgical, radiation oncology and medical oncology outpatient departments while treating the care-receiver with chemoradiotherapy for high grade glioma. Potential participants will be provided with an information brochure.

Randomisation will take place at the School of Nursing, Midwifery and Paramedicine at Curtin University. Randomisation will be stratified by site. Participants will be informed once randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer sequence generation.
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/01/2014
Actual
16/01/2014
Date of last participant enrolment
Anticipated
Actual
25/06/2019
Date of last data collection
Anticipated
Actual
8/04/2020
Sample size
Target
240
Accrual to date
Final
188
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 1546 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 3806 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [3] 9327 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 9328 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 9329 0
St George Hospital - Kogarah
Recruitment hospital [6] 9330 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [7] 9331 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 17996 0
2065 - St Leonards
Recruitment postcode(s) [2] 17997 0
2031 - Randwick
Recruitment postcode(s) [3] 17998 0
2217 - Kogarah
Recruitment postcode(s) [4] 17999 0
2050 - Camperdown
Recruitment postcode(s) [5] 18000 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 286200 0
Hospital
Name [1] 286200 0
Sir Charles Gairdner Hospital
Country [1] 286200 0
Australia
Funding source category [2] 288044 0
Charities/Societies/Foundations
Name [2] 288044 0
The Cancer Council of WA
Country [2] 288044 0
Australia
Funding source category [3] 297892 0
Government body
Name [3] 297892 0
Cancer Australia
Country [3] 297892 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University
GPO Box U1987, Perth, WA 6845
Country
Australia
Secondary sponsor category [1] 285009 0
None
Name [1] 285009 0
Address [1] 285009 0
Country [1] 285009 0
Other collaborator category [1] 277138 0
University
Name [1] 277138 0
Address [1] 277138 0
Faculty of Health Sciences, Curtin University, GPO Box U1987, Perth, WA, 6845
Country [1] 277138 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288271 0
Sir Charles Gairdner Hospital
Ethics committee address [1] 288271 0
Ethics committee country [1] 288271 0
Australia
Date submitted for ethics approval [1] 288271 0
30/09/2013
Approval date [1] 288271 0
23/10/2013
Ethics approval number [1] 288271 0
2013-172
Ethics committee name [2] 292865 0
St John of God Hospital
Ethics committee address [2] 292865 0
Ethics committee country [2] 292865 0
Australia
Date submitted for ethics approval [2] 292865 0
09/01/2014
Approval date [2] 292865 0
12/02/2014
Ethics approval number [2] 292865 0
671
Ethics committee name [3] 298941 0
South Eastern Sydney Local Health District HREC
Ethics committee address [3] 298941 0
Ethics committee country [3] 298941 0
Australia
Date submitted for ethics approval [3] 298941 0
03/04/2016
Approval date [3] 298941 0
14/07/2016
Ethics approval number [3] 298941 0
HREC ref no:16/105 (HREC/16/POW/219)
Ethics committee name [4] 316185 0
Curtin University Human Research Ethics Committee
Ethics committee address [4] 316185 0
Ethics committee country [4] 316185 0
Australia
Date submitted for ethics approval [4] 316185 0
Approval date [4] 316185 0
13/11/2013
Ethics approval number [4] 316185 0
HR173/2013

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

Contacts
Principal investigator
Name 34868 0
A/Prof Georgia Halkett
Address 34868 0
Faculty of Health Sciences, Curtin University, GPO Box U1987, Perth, WA, 6845
Country 34868 0
Australia
Phone 34868 0
+61 8 9266 1762
Fax 34868 0
Email 34868 0
[email protected]
Contact person for public queries
Name 18115 0
Georgia Halkett
Address 18115 0
Faculty of Health Sciences, Curtin University, GPO Box U1987, Perth, WA, 6845
Country 18115 0
Australia
Phone 18115 0
+61 8 9266 1762
Fax 18115 0
Email 18115 0
[email protected]
Contact person for scientific queries
Name 9043 0
Georgia Halkett
Address 9043 0
Faculty of Health Sciences, Curtin University, GPO Box U1987, Perth, WA, 6845
Country 9043 0
Australia
Phone 9043 0
+61 8 9266 1762
Fax 9043 0
Email 9043 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
For reasons of sensitivity and because participants did not consent to data sharing for future studies.


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
SourceTitleYear of PublicationDOI
EmbaseProtocol for the Care-IS Trial: A randomised controlled trial of a supportive educational intervention for carers of patients with high-grade glioma (HGG).2015https://dx.doi.org/10.1136/bmjopen-2015-009477
EmbaseCarer preparedness improved by providing a supportive educational intervention for carers of patients with high-grade glioma: RCT results.2023https://dx.doi.org/10.1007/s11060-023-04239-0
N.B. These documents automatically identified may not have been verified by the study sponsor.