Open Access Study protocol

Protocol for the OUTREACH trial: a randomised trial comparing delivery of cancer systemic therapy in three different settings - patient's home, GP surgery and hospital day unit

Pippa G Corrie1*, Margaret Moody2, Victoria Wood1, Linda Bavister1, Toby Prevost3, Richard A Parker3, Ramon Sabes-Figuera4, Paul McCrone4, Helen Balsdon1, Karen McKinnon2, Brendan O'Sullivan1, Ray S Tan1 and Stephen IG Barclay3

Author Affiliations

1 Oncology Centre, Addenbrooke's Hospital, Cambridge, UK

2 West Suffolk Hospital, Bury St Edmunds, UK

3 General Practice and Primary Care Research Unit, University of Cambridge, UK

4 Centre for the Economics of Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Kings College London, UK

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BMC Cancer 2011, 11:467  doi:10.1186/1471-2407-11-467

Published: 29 October 2011

Abstract

Background

The national Cancer Reform Strategy recommends delivering care closer to home whenever possible. Cancer drug treatment has traditionally been administered to patients in specialist hospital-based facilities. Technological developments mean that nowadays, most treatment can be delivered in the out-patient setting. Increasing demand, care quality improvements and patient choice have stimulated interest in delivering some treatment to patients in the community, however, formal evaluation of delivering cancer treatment in different community settings is lacking. This randomised trial compares delivery of cancer treatment in the hospital with delivery in two different community settings: the patient's home and general practice (GP) surgeries.

Methods/design

Patients due to receive a minimum 12 week course of standard intravenous cancer treatment at two hospitals in the Anglia Cancer Network are randomised on a 1:1:1 basis to receive treatment in the hospital day unit (control arm), or their own home, or their choice of one of three neighbouring GP surgeries. Overall patient care, treatment prescribing and clinical review is undertaken according to standard local practice. All treatment is dispensed by the local hospital pharmacy and treatment is delivered by the hospital chemotherapy nurses. At four time points during the 12 week study period, information is collected from patients, nursing staff, primary and secondary care teams to address the primary end point, patient-perceived benefits (using the emotional function domain of the EORTC QLQC30 patient questionnaire), as well as secondary end points: patient satisfaction, safety and health economics.

Discussion

The Outreach trial is the first randomised controlled trial conducted which compares delivery of out-patient based intravenous cancer treatment in two different community settings with standard hospital based treatment. Results of this study may better inform all key stakeholders regarding potential costs and benefits of transferring clinical services from hospital to the community.

Trial registration number

ISRCTN: ISRCTN66219681

Keywords:
cancer treatment; chemotherapy; community care; care closer to home; out-patient service delivery