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Protocol for the Care-IS Trial: a randomised controlled trial of a supportive educational intervention for carers of patients with high-grade glioma (HGG).

This paper outlines the objectives of a randomised control trial that will be conducted to investigate primary carers of those with high-grade glioma.

Authors:
Halkett GK, Lobb EA, Miller L, Phillips JL, Shaw T, Moorin R, et al.

Authors notes:
BMJ Open. 2015;5(10):e009477.

Keywords:
Health economics, primary carers, caring, cancer, caregiving, healthcare, patients, distress, preparedness, healthcare resource utilisation

Abstract:
INTRODUCTION: 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.

PRIMARY HYPOTHESIS: This intervention will improve preparedness for caring and reduce carer psychological distress.

SECONDARY HYPOTHESIS: 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.

DISSEMINATION: Results will be reported in international peer-reviewed journals