Protocol for the Care-IS Trial: a randomised controlled trial of a supportive educational intervention for carers of patients with high-grade glioma (HGG).
BACKGROUND
High-grade glioma (HGG) is a rapidly progressive and debilitating disease. Primary carers experience significant levels of distress which impacts on their experience of caregiving, the quality of care received and the community in terms of the increased reliance on healthcare due to the potential development of complicated grief. This paper describes the protocol for testing the efficacy and feasibility of an intervention for primary carers of patients with HGG in order to improve preparedness to care and reduce carer distress.


METHODS
Randomised controlled trial. The target population is carers of patients with HGG who are undergoing combined chemoradiotherapy. The intervention consists of 4 components: (1) initial telephone assessment of unmet needs of the carer, (2) tailoring of a personalised resource folder, (3) home visit, (4) ongoing monthly telephone contact and support for 12 months. The control arm will receive usual care.
This intervention will improve preparedness for caring and reduce carer psychological distress.
This intervention will reduce carer unmet needs. The longer term aim of the intervention is to reduce patient healthcare resource utilisation and, by doing so, reduce costs. Assessments will be obtained at baseline, 8 weeks post intervention, then 4, 6 and 12 months. Participants will also complete a healthcare utilisation checklist and proxy performance status which will be assessed at baseline and monthly. 240 carers will be recruited. The sample size is 180. Multilevel mixed effects regression models will be applied to test the effect of the intervention.


METHODS
Ethics approval has been gained from Curtin University and the participating sites.


RESULTS
Results will be reported in international peer-reviewed journals.


BACKGROUND
Australian and New Zealand Clinical Trials Registration (ACTRN)12612001147875.
Faculty of Health Sciences, School of Nursing and Midwifery, Curtin University, Bentley, Perth, Western Australia, Australia.
Georgia K B
GK
Halkett
Calvary Health Care Kogarah and Cunningham Centre for Palliative Care, Sydney, New South Wales, Australia School of Medicine, The University of Notre Dame, Sydney, New South Wales, Australia.
Elizabeth A
EA
Lobb
Department of Psychiatry, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia Department of Health WA, WA Cancer and Palliative Carer Network, Perth, Western Australia, Australia.
Lisa
L
Miller
Faculty of Health, Centre for Cardiovascular and Chronic Care, University of Technology Sydney, Sydney, New South Wales, Australia.
Jane L
JL
Phillips
Telethon Kids Institute, Perth, Western Australia, Australia.
Thérése
T
Shaw
School of Public Health, Curtin University, Perth, Western Australia, Australia School of Population Health, The University of Western Australia, Perth, Western Australia, Australia Department of Research, Silver Chain Group, Perth, Western Australia, Australia.
Rachael
R
Moorin
Department of Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.
Anne
A
Long
Department of Health WA, WA Cancer and Palliative Carer Network, Perth, Western Australia, Australia.
Anne
A
King
Faculty of Health Sciences, School of Nursing and Midwifery, Curtin University, Bentley, Perth, Western Australia, Australia.
Jenny
J
Clarke
Carers WA, Perth, Western Australia, Australia.
Stephanie
S
Fewster
Centre for Palliative Care St Vincent's Hospital Melbourne, Victoria, Australia Department of Nursing, University of Melbourne, Melbourne, Victoria, Australia School of Nursing and Midwifery, Queen's University Belfast, Northern Ireland, United Kingdom.
Peter
P
Hudson
Department of Palliative Care, Braeside Hospital, Prairiewood, New South Wales, Australia.
Meera
M
Agar
Department of Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia School of Medicine and Pharmacology, University of Western Australia, Nedlands, Western Australia, Australia.
Anna K
AK
Nowak
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001315:Australia; D017028:Caregivers / Q000193:education* / Q000523:psychology; D002985:Clinical Protocols; D003365:Costs and Cost Analysis; D005260:Female; D005910:Glioma / Q000451:nursing*; D017048:Health Care Costs; D006792:House Calls; D006801:Humans; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology*; D012107:Research Design; D055815:Young Adult
HEALTH ECONOMICS