Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
96 participants
OBSERVATIONAL
2009-01-31
Brief Summary
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PURPOSE: This clinical trial is studying fatigue in breast cancer survivors.
Detailed Description
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* 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.
Conditions
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Keywords
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Interventions
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protein analysis
laboratory biomarker analysis
mass spectrometry
questionnaire administration
assessment of therapy complications
cognitive assessment
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* 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
FEMALE
No
Sponsors
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St George's, University of London
OTHER
Principal Investigators
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Ollie Minton, MD
Role: PRINCIPAL_INVESTIGATOR
St George's, University of London
Locations
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St. Georges, University of London
London, England, United Kingdom
Countries
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Facility Contacts
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Ollie Minton, MD
Role: primary
Other Identifiers
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SGUL-PTF-Mechanisms
Identifier Type: -
Identifier Source: secondary_id
EU-20958
Identifier Type: -
Identifier Source: secondary_id
CDR0000647658
Identifier Type: -
Identifier Source: org_study_id