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Open Access Study protocol

Vocational rehabilitation services for patients with cancer: design of a feasibility study incorporating a pilot randomised controlled trial among women with breast cancer following surgery

Richard G Kyle1*, Bill Culbard1, Josie Evans2, Nicola M Gray3, Dolapo Ayansina4 and Gill Hubbard1

Author Affiliations

1 Cancer Care Research Centre, School of Nursing, Midwifery and Health, University of Stirling, Stirling, UK

2 School of Nursing, Midwifery and Health, University of Stirling, Stirling, UK

3 Centre of Academic Primary Care, Division of Applied Health Sciences, School of Medicine and Dentistry, University of Aberdeen, UK

4 Division of Applied Health Sciences, School of Medicine and Dentistry, University of Aberdeen, UK

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Trials 2011, 12:89  doi:10.1186/1745-6215-12-89

Published: 30 March 2011

Abstract

Background

Due to improvements in cancer survival the number of people of working age living with cancer across Europe is likely to increase. UK governments have made commitments to reduce the number of working days lost to ill-health and to improve access to vocational rehabilitation (VR) services. Return to work for people with cancer has been identified as a priority. However, there are few services to support people to remain in or return to work after cancer and no associated trials to assess their impact. A pilot randomised controlled trial among women with breast cancer has been designed to assess the feasibility of a larger definitive trial of VR services for people with cancer.

Methods

Patients are being recruited from three clinical sites in two Scottish National Health Service (NHS) Boards for 6 months. Eligible patients are all women who are: (1) aged between 18 and 65 years; (2) in paid employment or self-employed; (3) living or working in Lothian or Tayside, Scotland, UK; (4) diagnosed with an invasive breast cancer tumour; (5) treated first with surgery. Patients are randomly allocated to receive referral to a VR service or usual care, which involves no formal employment support. The primary outcome measure is self-reported sickness absence in the first 6 months following surgery. Secondary outcome measures include changes in quality of life (FACT-B), fatigue (FACIT-Fatigue) and employment status between baseline and 6- and 12-months post-surgery. A post-trial evaluation will be conducted to assess the acceptability of the intervention among participants and the feasibility of a larger, more definitive, trial with patients with lung and prostate cancer.

Discussion

To our knowledge this is the first study to determine the feasibility of a randomised controlled trial of the effectiveness of VR services to enable people with cancer to remain in or return to employment. The study will provide evidence to assess the relevance and feasibility of a larger future trial involving patients with breast, prostate or lung cancer and inform the development of appropriate VR services for people living with cancer.

Trial Registration

ISRCTN: ISRCTN29666484

Registration date: 07/10/10; Randomisation of first patient: 03/12/10