Fatigue in Breast Cancer Survivors
|ClinicalTrials.gov Identifier: NCT00972400|
Recruitment Status : Unknown
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : September 4, 2009
Last Update Posted : August 26, 2013
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer Cancer Survivor Fatigue Psychosocial Effects of Cancer and Its Treatment||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|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||96 participants|
|Official Title:||Biological Mechanisms of Fatigue in Breast Cancer Survivors|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||January 2011|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00972400
|St. Georges, University of London||Recruiting|
|London, England, United Kingdom, SW17 ORE|
|Contact: Ollie Minton, MD 44-2087-252-620|
|Principal Investigator:||Ollie Minton, MD||St George's, University of London|