Study protocol

Improving the quality and efficiency of follow-up after curative treatment for breast cancer – rationale and study design of the MaCare trial

Merel L Kimman^1,2 , Adri C Voogd³ , Carmen D Dirksen⁴ , Paul Falger⁵ , Pierre Hupperets⁶ , Kristien Keymeulen⁷ , Marlene Hebly⁷ , Cary Dehing¹ , Philippe Lambin^1,2,8 and Liesbeth J Boersma^1,2,8

¹  Maastro Clinic, Maastricht, The Netherlands

²  Department GROW – MAASTRO, Maastricht University, The Netherlands

³  Department of Epidemiology, Maastricht University, The Netherlands

⁴  Department of Clinical Epidemiology and Medical Technology Assessment, University Hospital Maastricht, The Netherlands

⁵  Department of Medical Psychology, University Hospital Maastricht, The Netherlands

⁶  Department of Medical Oncology, University Hospital Maastricht, The Netherlands

⁷  Department of Surgery, University Hospital Maastricht, The Netherlands

⁸  Department of Radiation Oncology, University Hospital Maastricht, The Netherlands

author email corresponding author email

BMC Cancer 2007, 7:1doi:10.1186/1471-2407-7-1

Published:	2 January 2007

Abstract

Background

After 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/design

The 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.

Discussion

Reduced 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.