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
17/10/2018
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
Recruiting
Date of first participant enrolment
Anticipated
6/01/2014
Actual
16/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
170
Final
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
HREC SCGH
Hospital Avenue
Nedlands
WA 6009
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
12 Salvado Road
Subiaco
Western Australia 6904
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
Ethics committee address [3] 298941 0
Room G71 East Wing
Edmund Blacket Building
Prince of Wales Hospital
Randwick NSW 2031
Ethics committee country [3] 298941 0
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)

Summary
Brief summary
High grade glioma (HGG) is a term used to encompass grade III anaplastic astrocytomas, oligodendrogliomas and glioblastoma multiforme. This is a rapidly terminal, progressive, and significantly debilitating group of diseases which robs patients of function, cognition, and personality, making this a highly distressing disease for patients, families and carers. In addition to the general cancer related caregiving issues, the impact of the disease on the patients’ ability to function leads to reduced quality of life, increased stress and carer burden for their caregiver . The diagnosis of a brain tumour is particularly stressful for carers because the prognosis is dire and life expectancy short. These carers report increased stress and distress levels and decreased quality of life compared to carers of patients with cancers with a good prognosis. There are more than 200 problems and burdens identified by caregivers, which fall under several categories including: physical health problems, social problems and information needs, emotional problems and burdens related to responsibilities and impact on daily life.
Psychosocial interventions for caregivers in a range of situations have been developed with various aims including improving caregiver understanding and ability to care, self-efficacy, quality of life, stress reduction, and improving communication and relationships in the family. There is a paucity of information regarding the role or effect of interventions addressing the unmet needs of caregivers of patients with HGG.
Thus far this group has carried out two investigations into the experience and needs of patients with HGG and their caregivers. The first was a qualitative study of the needs of patients with HGG and their caregivers. Caregivers described a time of rapid change and a steep learning curve where they struggled with caring for partners with major disabilities and not knowing where to seek additional support or assistance (Halkett et al. 2010; McConigley et al. 2010). The second was a quantitative study (SCGH HREC 2006-146) which examined the experiences of 100 patient-carer dyads at three time points during the disease trajectory: during combined chemoradiotherapy, and 3 and 6 months later. 31% of caregivers reported moderate distress (DT score 5-6) and 31% reported extreme distress (score 7-10). Caregivers also
reported significantly more distress than patients (mean 5.1 vs. 4.1; paired t test p=0.01). Caregiver distress was associated with higher scores on the general health questionnaire (r=0.61, p<0.001). The top 5 moderate/high caregiver unmet needs were: 1. accessing prognostic information; 2. accessing financial support and government benefits; 3. accessible hospital parking; 4. impact of caring on usual life; and 5. reducing stress in the patients’ life. These preliminary results will be presented in a poster at COSA in November 2012.
The development of our intervention is based on our preliminary data and the identification of several key components including the caregiver’s preparedness to care, sense of control, competence, self-efficacy, anxiety, depression and distress, social support, information, a sense of reward, meaningfulness, positive emotions, optimism, respite and relationship with the care-receiver. Our intervention is currently in the development phase and is aimed to cover all these areas. We are seeking support and advice regarding the development of the intervention from a variety of sources including medical oncologists, neurosurgeons, radiation oncologists, palliative care physicians, psychologists, social workers, nurses, experienced representatives from Carers WA and COGNO, as well as consumer representatives. The purpose of this project is to determine the feasibility and efficacy of this supportive-educational intervention for caregivers of patients with HGG.
Trial website
Trial related presentations / publications
Halkett, G. K. B., Lobb EA, Miller L, Shaw T, Moorin R, Long A, King A, Clarke J, Fewster S, Nowak AK. (2017) Feasibility Testing and Refinement of a Supportive Educational Intervention for Carers of Patients with High-Grade Glioma - a Pilot Study. J Cancer Educ. 2017 Feb 11. doi: 10.1007/s13187-017-1175-x.
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
Ms Ms Jenny Clarke
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 1757
Fax 18115 0
Email 18115 0
[email protected]
Contact person for scientific queries
Name 9043 0
Prof Prof Anna Nowak
Address 9043 0
Department of Medical Oncology
Sir Charles Gairdner Hospital
Locked Bag 2012
Nedlands
WA 6009
Country 9043 0
Australia
Phone 9043 0
+61 8 9346 1222
Fax 9043 0
Email 9043 0
N/A

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23244Study protocolHalkett, G. K., E. A. Lobb, L. Miller, J. L. Phillips, T. Shaw, R. Moorin, A. Long, A. King, J. Clarke, S. Fewster, P. Hudson, M. Agar and A. K. Nowak (2015). "Protocol for the Care-IS Trial: a randomised controlled trial of a supportive educational intervention for carers of patients with high-grade glioma (HGG)." BMJ Open 5(10): e009477. https://bmjopen.bmj.com/content/5/10/e009477.long  

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
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
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
N.B. These documents automatically identified may not have been verified by the study sponsor.