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

JAMA. 1994 May 25;271(20):1587-92. doi: 10.1001/jama.1994.03510440047031.


Objective: To assess prospectively the impact on survival and health-related quality of life of two follow-up protocols in patients with early breast cancer.

Design: Randomized controlled clinical trial.

Setting: Multicenter study involving 26 general hospitals in Italy.

Patients: A consecutive sample of 1320 women younger than 70 years with stage I, II, and III unilateral primary breast cancer.

Intervention: 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.

Main outcome measures: Primary end points were overall survival and health-related quality of life.

Results: 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.

Conclusions: 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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Biomarkers, Tumor / blood
  • Bone and Bones / diagnostic imaging
  • Breast Neoplasms / mortality*
  • Breast Neoplasms / pathology
  • Breast Neoplasms / psychology
  • Breast Neoplasms / therapy*
  • Female
  • Humans
  • Liver / diagnostic imaging
  • Mammography
  • Middle Aged
  • Neoplasm Metastasis / diagnosis*
  • Outcome and Process Assessment, Health Care*
  • Patient Compliance
  • Prospective Studies
  • Quality of Life*
  • Radiography, Thoracic
  • Radionuclide Imaging
  • Survival Rate
  • Ultrasonography


  • Biomarkers, Tumor