Halkett 2015.

Trial name or title	Care‐IS trial
Methods	Multicentre prospective phase III randomised controlled trial
Participants	Adult primary carers of a patient with high‐grade glioma who 1. is currently undergoing active treatment and is within 2 months of diagnosis; and 2. is currently attending the outpatient departments of 1 of the participating sites. The caregiver should furthermore 1. aged >18 years; 2. understand and speak English; 3. have no mental, cognitive, or functional disability; 4. be willing and able to comply with study requirements; 5. have no familial, sociological, or geographical condition that might hamper compliance; 6. have no severe intercurrent medical or psychotic disease that would hinder the ability to participation in the study.
Interventions	The Care‐IS intervention is guided by a nurse and will consist of: 1. a telephone needs assessment; 2. access to a tailored resource file for the caregiver based on the needs that had been identified; 3. an educational and supportive home visit from the nurse; 4. monthly telephone check‐ups.
Outcomes	Primary outcomes Caregiver preparedness (Preparedness for Caregiving Scale) Caregiver distress (Distress Thermometer) Secondary outcomes Anxiety and depression (Hospital Anxiety and Depression Scale) QoL (Caregiver QoL Index – Cancer) Caregiver competence (Carer Competence Scale) Supportive care needs (Partner and Caregivers Supportive Care Needs Scale/Brain Tumour Specific Supportive Carer Needs for Carers Survey) Health economic cost‐consequences (checklist of services used)
Starting date	2015
Contact information	G.Halkett@curtin.edu.au
Notes