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Trial registered on ANZCTR


Registration number
ACTRN12612001148864
Ethics application status
Approved
Date submitted
28/10/2012
Date registered
30/10/2012
Date last updated
20/12/2018
Date data sharing statement initially provided
20/12/2018
Date results information initially provided
20/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study of caregiver intervention and support for carers of people with brain tumours
Scientific title
A pilot study of a supportive educational intervention for caregivers of patients with high grade glioma
Secondary ID [1] 281448 0
None
Universal Trial Number (UTN)
U1111-1136-3146
Trial acronym
Care-IS Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Efficacy of Intervention for brain tumour caregivers 287711 0
Preparedness to care 287712 0
Caregiver Competence 287713 0
Caregiver Strain 287714 0
Condition category
Condition code
Other 288047 288047 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
In this pilot study, the intervention will be carried out for 6 months but the main assessments will only occur at baseline, 6 weeks and 3 months.
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. In the pilot study this will occur after registration and in the intervention study after randomisation to the intervention group. This should take 20 minutes.
2. 7-14 days later, 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. Caregviers 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. As new needs are identified, further information sheets will be supplied to the caregiver to insert into their resource folder.
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] 285954 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288258 0
Feasibility of the intervention and assessments as assessed in a feasibility questionnaire, rates of compliance and exclusion of surveys with floor or ceiling effects
Timepoint [1] 288258 0
Baseline, 6 weeks and 3 months post intervention.
Secondary outcome [1] 299704 0
Preparedness for Caregiving Scale (PCS)
Timepoint [1] 299704 0
Baseline, 6 weeks and 3 months post intervention
Secondary outcome [2] 355156 0
Distress Thermometer
Timepoint [2] 355156 0
Baseline, 6 weeks and 3 months post intervention
Secondary outcome [3] 355157 0
Hospital Anxiety and Depression Scale (HADS)
Timepoint [3] 355157 0
Baseline, 6 weeks and 3 months post intervention
Secondary outcome [4] 355158 0
Caregiver Quality of Life Index—Cancer (CQOLC)
Timepoint [4] 355158 0
Baseline, 6 weeks and 3 months post intervention
Secondary outcome [5] 355159 0
Carer Competence Scale
Timepoint [5] 355159 0
Baseline, 6 weeks and 3 months post intervention
Secondary outcome [6] 355160 0
Caregiver Strain Index
Timepoint [6] 355160 0
Baseline, 6 weeks and 3 months post intervention
Secondary outcome [7] 355161 0
Modified Caregiver Strain Index
Timepoint [7] 355161 0
Baseline, 6 weeks and 3 months post intervention
Secondary outcome [8] 355162 0
Partner and Caregiver Supportive Care Needs Scale
Timepoint [8] 355162 0
Baseline, 6 weeks and 3 months post intervention
Secondary outcome [9] 355163 0
Brain Tumour Specific Supportive Care needs for Carers
survey
Timepoint [9] 355163 0
Baseline, 6 weeks and 3 months post intervention
Secondary outcome [10] 355164 0
European Cooperative Oncology Group (ECOG) Performance Status (patient’s level of functioning)
Timepoint [10] 355164 0
Baseline and monthly (total of 6 months)
Secondary outcome [11] 355165 0
Karnofsky performance scale (patient's functional impairment)
Timepoint [11] 355165 0
Baseline and monthly (total of six months)
Secondary outcome [12] 355166 0
EuroQoL (EQ-5D)
Timepoint [12] 355166 0
Baseline, 6 weeks and 3 months post intervention
Secondary outcome [13] 355167 0
Healthcare Utilisation. A structured checklist identified: unplanned hospital visits and length of stay, emergency attendance, ambulance access, hospice and respite admission, imaging procedures, pathology procedures, access to healthcare professionals (e.g. general practitioner, nurse, medical oncologist, radiation oncologist, neurosurgeon, cancer nurse coordinator, physiotherapist, occupational therapist, social worker and psychologist), medications (prescribed and non-prescribed), parking costs and any out-of-pocket costs incurred for both carer and patient.
Timepoint [13] 355167 0
Monthly (total of six months)

Eligibility
Key inclusion criteria
Primary caregivers of patients with high grade glioma who were undergoing chemotherapy,
radiotherapy or combined chemoradiotherapy and within 2 months of initial diagnosis.
Caregiver of patients currently attending the neurosurgical, medical or radiation oncology outpatient departments.
Sufficient understanding of verbal and written English language.
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
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No concealment procedures. 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. If amenable to the study, the research nurse will contact the participant and organise delivery of full participant information and consent form and subsequently obtain consent.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2013
Actual
4/07/2013
Date of last participant enrolment
Anticipated
Actual
8/01/2014
Date of last data collection
Anticipated
Actual
28/07/2014
Sample size
Target
20
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 1544 0
Sir Charles Gairdner Hospital - Nedlands

Funding & Sponsors
Funding source category [1] 286216 0
Hospital
Name [1] 286216 0
Sir Charles Gairdner Hospital
Country [1] 286216 0
Australia
Funding source category [2] 288040 0
Charities/Societies/Foundations
Name [2] 288040 0
The Cancer Council of WA
Country [2] 288040 0
Australia
Funding source category [3] 301493 0
Government body
Name [3] 301493 0
Western Australian Cancer and Palliative Care Network, Department of Health Western Australia.
Country [3] 301493 0
Australia
Primary sponsor type
University
Name
Cancer and palliative research and evaluation unit, University of Western Australia
Address
University of Western Australia
35, Stirling Highway
Crawley 6009
Western Australia
Country
Australia
Secondary sponsor category [1] 285025 0
None
Name [1] 285025 0
Address [1] 285025 0
Country [1] 285025 0
Other collaborator category [1] 277141 0
University
Name [1] 277141 0
Curtin University
Address [1] 277141 0
Faculty of Health Sciences, Curtin University, 7 Parker Place, Technology Park Bentley 6102 Western Australia
Country [1] 277141 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288291 0
Sir Charles Gairdner Hospital Ethics Committee
Ethics committee address [1] 288291 0
HREC
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
WA 6009
Ethics committee country [1] 288291 0
Australia
Date submitted for ethics approval [1] 288291 0
30/10/2012
Approval date [1] 288291 0
15/02/2013
Ethics approval number [1] 288291 0
2012-186

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
Public notes

Contacts
Principal investigator
Name 34882 0
Dr Georgia Halkett
Address 34882 0
Faculty of Health Sciences, Curtin University, GPO Box U1987, Perth, WA, 6845
Country 34882 0
Australia
Phone 34882 0
618 9266 1762
Fax 34882 0
618 9266 1770
Email 34882 0
[email protected]
Contact person for public queries
Name 18129 0
Ms Jenny Clarke
Address 18129 0
Faculty of Health Sciences, Curtin University, GPO Box U1987, Perth, WA, 6845
Country 18129 0
Australia
Phone 18129 0
+61 8 9266 1757
Fax 18129 0
Email 18129 0
[email protected]
Contact person for scientific queries
Name 9057 0
Prof Prof Anna Nowak
Address 9057 0
Department of Medical Oncology
Sir Charles Gairdner Hospital
Locked Bag 2012
Nedlands
WA 6009
Country 9057 0
Australia
Phone 9057 0
+61 8 9346 1222
Fax 9057 0
Email 9057 0
N/A

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Permission was not sought from participants to make individual participant data available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Feasibility Testing and Refinement of a Supportive... [More Details]

Documents added automatically
No additional documents have been identified.