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Open Access Study protocol

Enhancing return-to-work in cancer patients, development of an intervention and design of a randomised controlled trial

Sietske J Tamminga1*, Angela GEM de Boer1, Jos HAM Verbeek12, Taina Taskila13 and Monique HW Frings-Dresen1

Author Affiliations

1 Coronel Institute of Occupational Health, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands

2 Finisch Institute of Occupational Health Field, Kuopio, Finland

3 Primary Care Clinical Sciences, University of Birmingham, Birmingham, UK

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BMC Cancer 2010, 10:345  doi:10.1186/1471-2407-10-345

Published: 1 July 2010

Abstract

Background

Compared to healthy controls, cancer patients have a higher risk of unemployment, which has negative social and economic impacts on the patients and on society at large. Therefore, return-to-work of cancer patients needs to be improved by way of an intervention. The objective is to describe the development and content of a work-directed intervention to enhance return-to-work in cancer patients and to explain the study design used for evaluating the effectiveness of the intervention.

Development and content of the intervention

The work-directed intervention has been developed based on a systematic literature review of work-directed interventions for cancer patients, factors reported by cancer survivors as helping or hindering their return-to-work, focus group and interview data for cancer patients, health care professionals, and supervisors, and vocational rehabilitation literature. The work-directed intervention consists of: 1) 4 meetings with a nurse at the treating hospital department to start early vocational rehabilitation, 2) 1 meeting with the participant, occupational physician, and supervisor to make a return-to-work plan, and 3) letters from the treating physician to the occupational physician to enhance communication.

Study design to evaluate the intervention

The treating physician or nurse recruits patients before the start of initial treatment. Patients are eligible when they have a primary diagnosis of cancer, will be treated with curative intent, are employed at the time of diagnosis, are on sick leave, and are between 18 and 60 years old. After the patients have given informed consent and have filled out a baseline questionnaire, they are randomised to either the control group or to the intervention group and receive either care as usual or the work-directed intervention, respectively. Primary outcomes are return-to-work and quality of life. The feasibility of the intervention and direct and indirect costs will be determined. Outcomes will be assessed by a questionnaire at baseline and at 6, 12, 18, and 24 months after baseline.

Discussion

This study will provide information about the effectiveness of a work-directed intervention for cancer patients. The intention is to implement the intervention in normal care if it has been shown effective.

Trial registration

NTR1658