Trial Information

Biological Mechanisms of Fatigue in Breast Cancer Survivors

OBJECTIVES:

- To investigate the relationship between fatigue severity; protein biomarkers; and
measures of activity, sleep, mood, and cognition in breast cancer survivors.

- To identify and quantify serum biomarkers and underlying biological pathways unique to
cancer-related fatigue syndrome in these survivors.

- To map changes over time in order to explore the inter-relationships between these
variables.

OUTLINE: Participants undergo fatigue assessment by the Diagnostic Interview for Cancer
Related Fatigue and the FACT-Fatigue questionnaire; psychological symptoms assessment by the
Structured Clinical Interview for DSM-IV, Hospital Anxiety and Depression Scale, and the
Insomnia Severity Index questionnaires; and quality of life assessment by the EORTC-QLQc30
and EORTC-QLQ-BR23 questionnaires twice approximately 3 months apart.

Participants also undergo activity level, circadian rhythm, and sleep measurements by the
Micro-mini® Motionlogger actigraphy and measurement of cognitive disturbances by the
Cantabeclipse™ technology.

Participants undergo blood sample collection for protein analysis by 2D gel electrophoresis
and mass spectrometry.