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


CONCLUSIONS
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.
Kimman
Merel L
ML
Maastro Clinic, Maastricht, The Netherlands. merel.kimman@maastro.nl
Voogd
Adri C
AC
Dirksen
Carmen D
CD
Falger
Paul
P
Hupperets
Pierre
P
Keymeulen
Kristien
K
Hebly
Marlene
M
Dehing
Cary
C
Lambin
Philippe
P
Boersma
Liesbeth J
LJ
D001943:Breast Neoplasms / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007407:Interviews as Topic; D008327:Mammography; D015337:Multicenter Studies as Topic / Q000592:standards*; D009426:Netherlands; D009859:Oncology Nursing; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design / Q000592:standards*; D013689:Telephone; D016896:Treatment Outcome