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. Intensive diagnostic follow-up after treatment of primary breast cancer. A randomized trial. National Research Council Project on Breast Cancer follow-up. Comparison of breast cancer patient satisfaction with follow-up in primary care versus specialist care: results from a randomized controlled trial.
To assess prospectively the impact on survival and health-related quality of life of two follow-up protocols in patients with early breast cancer.
                Randomized controlled clinical trial.
                Multicenter study involving 26 general hospitals in Italy.
                A consecutive sample of 1320 women younger than 70 years with stage I, II, and III unilateral primary breast cancer.
                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.
                Primary end points were overall survival and health-related quality of life.
                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.
                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. To evaluate the effectiveness of early detection of intrathoracic and bone metastases in reducing mortality in breast cancer patients.
                Randomized clinical trial allocating breast cancer patients to two alternative follow-up protocols (intensive vs clinical) for at least 5 years.
                Twelve breast clinics (referral centers) in different areas in Italy.
                A total of 1243 consecutive patients (either premenopausal or postmenopausal) surgically treated for unilateral invasive breast carcinoma with no evidence of metastases. The two study groups were well balanced in terms of clinical and prognostic characteristics.
                Patients in both treatment groups had physical examination and mammography, while patients of the intensive follow-up group had, in addition, chest roentgenography and bone scan every 6 months.
                Vital status at 5 years was the main outcome; information was available for all except five patients (0.4%). Relapse-free survival was also analyzed.
                Overall, 393 recurrences (104 local and 289 distant) were observed during the study. Increased detection of isolated intrathoracic and bone metastases was evident in the intensive follow-up group compared with the clinical follow-up group (112 vs 71 cases), while no difference was observed for other sites and for local and/or regional recurrences. The 5-year relapse-free survival rate was significantly higher for the clinical follow-up group, with patients in the intensive follow-up group showing earlier detection of recurrences. No difference in 5-year overall mortality (18.6% vs 19.5%) was observed between the two follow-up groups.
                Periodic chest roentgenography and bone scan allow earlier detection of distant metastases, but anticipated diagnosis appears to be the only effect of intensive follow-up, and no impact on prognosis is evident after 5 years. Periodic intensive follow-up with chest roentgenography and bone scan should not be recommended as a routine policy. Routine follow-up of breast cancer patients in specialist clinics is standard practice in most countries. Follow-up involves regularly scheduled breast cancer check-ups during the disease-free period. The aims of follow-up are to detect breast cancer recurrence and to provide psychosocial support to the patient; however, little is known about patients' views on breast cancer follow-up.
                To assess the effect on patient satisfaction of transferring primary responsibility for follow-up of women with breast cancer in remission from hospital outpatient clinics to general practice.
                Randomized controlled trial with 18 months' follow-up in which women received routine follow-up either in hospital outpatient clinics or from their own general practitioner. Two hundred and ninety-six women with breast cancer in remission receiving regular follow-up care at two district general hospitals in England were included in the study. Patient satisfaction was measured by means of a self-administered questionnaire supplied three times during the 18-month study period.
                The general practice group selected responses indicating greater satisfaction than did the hospital group on virtually every question. Furthermore, in the general practice group there was a significant increase in satisfaction over baseline; a similar significant increase in satisfaction over baseline was not found in the hospital group.
                Patients with breast cancer were more satisfied with follow-up in general practice than in hospital outpatient departments. When discussing follow-up with breast cancer patients, they should be provided with complete and accurate information about the goals, expectations, and limitations of the follow-up programme so that they can make an informed choice.
This updated review of RCTs conducted almost 20 years ago suggest that follow-up programs based on regular physical examinations and yearly mammography alone are as effective as more intensive approaches based on regular performance of laboratory and instrumental tests in terms of timeliness of recurrence detection, overall survival and quality of life. 
In one RCT, follow-up care performed by trained general practitioners working in an organized practice setting had comparable effectiveness to that delivered by hospital-based specialists in terms of quality of life and time to detection of distant metastases.