Abstract
BackgroundAfter curative treatment for breast cancer women frequently attend scheduled follow-up examinations. Usually the follow-up is most frequent in the first 2–3 years (2–4 times a year); thereafter the frequency is reduced to once a year in most countries. Its main aim is to detect local disease recurrence, or a second primary breast cancer, but also to provide information and psychosocial support. However, the cost-effectiveness of these frequent visits is under much debate, leading to a search for less intensive and more cost-effective follow-up strategies.In this paper the design of the MaCare trial is described. This trial compares the cost-effectiveness of four follow-up strategies for curatively treated breast cancer patients. We investigate the costs and effects of nurse-led telephone follow-up and a short educational group programme.Methods/designThe MaCare trial is a multi centre randomised clinical trial in which 320 breast cancer patients are randomised into four follow-up strategies, focussed on the first 18 months after treatment: 1) standard follow-up; 2) nurse-led telephone follow-up; 3) arm 1 with the educational group programme; 4) arm 2 with the educational group programme. Data is collected at baseline and 3, 6, 12 and 18 months after treatment. The primary endpoint of the trial is cancer-specific quality of life as measured by the global health/QoL scale of the EORTC QLQ-C30. Secondary outcomes are perceived feelings of control, anxiety, patients' satisfaction with follow-up and costs. A cost-effectiveness analysis will be performed from a societal perspective.DiscussionReduced follow-up strategies for breast cancer have not yet been widely applied in clinical practice. Improvement of psychosocial support and information to patients could lead to a better acceptance of reduced follow-up. The MaCare trial combines a reduced follow-up strategy with additional psychosocial support. Less frequent follow-up can reduce the burden on medical specialists and costs. The educational group programme can improve QoL of patients, but also less frequent follow-up can improve QoL by reducing the anxiety experienced for each follow-up visit. Results of the trial will provide knowledge on both costs and psychosocial aspects regarding follow-up and are expected in 2009.
Highlights
After curative treatment for breast cancer women frequently attend scheduled follow-up examinations
Two interventions for early breast cancer follow-up were developed for the study that is discussed in this paper; nurse-led telephone follow-up and a short educational group programme (EGP)
2) Nurse-led telephone follow-up; a mammography at one year combined with an outpatient clinic visit, and telephone interviews by a breast care nurse (BCN) or nurse practitioner (NP) at the same time points as during the usual follow-up (i.e. 3, 6, 9 and 18 months)
Summary
Current frequent follow-up is not meeting its intended aims, but does raise the burden on medical specialists, leading to high medical costs. By performing an economic evaluation parallel to the trial, the ultimate aim is to find an alternative and more cost-effective follow-up strategy. We expect the educational group programme to help breast cancer patients and their partners in dealing effectively and efficiently with the consequences of a recent diagnosis and treatment of a potentially fatal disease. This increase in perceived behavioural control is expected to improve QoL. The nurse-led telephone calls are expected to render visits to the outpatient clinic superfluous, which
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