Fatigue in Breast Cancer Survivors

Overview

RATIONALE: Gathering information over time from blood samples and measurements of activity, sleep, mood, and cognition may help doctors learn more about fatigue in breast cancer survivors and plan the best treatment. PURPOSE: This clinical trial is studying fatigue in breast cancer survivors.

Full Title of Study: “Biological Mechanisms of Fatigue in Breast Cancer Survivors”

Study Type

  • Study Type: Observational
  • Study Primary Completion Date: January 2011

Detailed Description

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-miniĀ® Motionlogger actigraphy and measurement of cognitive disturbances by the Cantabeclipseā„¢ technology. Participants undergo blood sample collection for protein analysis by 2D gel electrophoresis and mass spectrometry.

Interventions

  • Genetic: protein analysis
  • Other: laboratory biomarker analysis
  • Other: mass spectrometry
  • Other: questionnaire administration
  • Procedure: assessment of therapy complications
  • Procedure: cognitive assessment
  • Procedure: quality-of-life assessment

Clinical Trial Outcome Measures

Primary Measures

  • Relationship between fatigue severity; protein biomarkers; and measures of activity, sleep, mood, and cognition
  • Identification and quantification of serum biomarkers underlying biological pathways unique to cancer-related fatigue syndrome
  • Inter-relationships between variables

Participating in This Clinical Trial

DISEASE CHARACTERISTICS:

  • Disease-free breast cancer survivors between 3 months and 2 years after completion of primary treatment – Recruited from the nurse-led breast cancer follow-up clinic at St George's Hospital PATIENT CHARACTERISTICS: – Sufficient English language skills – No significant cognitive impairment – No concurrent severe combined immunodeficiency disease PRIOR CONCURRENT THERAPY: – See Disease Characteristics

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • St George’s, University of London
  • Overall Official(s)
    • Ollie Minton, MD, Principal Investigator, St George’s, University of London

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