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Impact of follow-up testing on survival and health-related quality of life in breast cancer patients. A multicenter randomized controlled trial. The GIVIO Investigators
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1994
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Quality Of LifeBreast OncologyHealth-related QualityCancer ManagementOncologyBreast Cancer PatientsBreast ImagingPatient-reported OutcomeGivio InvestigatorsContralateral Breast CancerRadiation OncologyCancer ResearchRadiologyHealth SciencesIntensive SurveillanceHealth PolicyOutcomes ResearchCancer PrognosisCancer DiagnosisNursingCancer ScreeningBreast CancerMedicine
<h3>Objective.</h3> —To assess prospectively the impact on survival and health-related quality of life of two follow-up protocols in patients with early breast cancer. <h3>Design.</h3> —Randomized controlled clinical trial. <h3>Setting.</h3> —Multicenter study involving 26 general hospitals in Italy. <h3>Patients.</h3> —A consecutive sample of 1320 women younger than 70 years with stage I, II, and III unilateral primary breast cancer. <h3>Intervention.</h3> —Patients were randomly assigned to an intensive surveillance, which included physician visits and performance of bone scan, liver echography, chest roentgenography, and laboratory tests at predefined intervals (n=655), or to a control regimen (n=665), in which patients were seen by their physicians at the same frequency but only clinically indicated tests were performed. Both groups received a yearly mammogram aimed at detecting contralateral breast cancer. <h3>Main Outcome Measures.</h3> —Primary end points were overall survival and health-related quality of life. <h3>Results.</h3> —Compliance to the two follow-up protocols was more than 80%. At a median follow-up of 71 months, no difference was apparent in overall survival with 132 deaths (20%) in the intensive group and 122 deaths (18%) in the control group. No significant differences were apparent in time to detection of recurrence between the two groups. Measurements of health-related quality of life (ie, overall health and quality-of-life perception, emotional well-being, body image, social functioning, symptoms, and satisfaction with care) at 6,12, 24, and 60 months of follow-up did not show differences by type of care received. <h3>Conclusions.</h3> —Results of this trial support the view that a protocol of frequent laboratory tests and roentgenography after primary treatment for breast cancer does not improve survival or influence health-related quality of life. Routine use of these tests should be discouraged. (<i>JAMA</i>. 1994;271:1587-1592)