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| ID | Type | Description | Link |
|---|---|---|---|
| SGUL-PTF-Mechanisms | |||
| EU-20958 |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| protein analysis | Genetic | |||
| laboratory biomarker analysis | Other | |||
| mass spectrometry | Other | |||
| questionnaire administration | Other | |||
| assessment of therapy complications | Procedure | |||
| cognitive assessment | Procedure | |||
| quality-of-life assessment | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Ollie Minton, MD | St George's, University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Georges, University of London | Recruiting | London | England | SW17 ORE | United Kingdom |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013058 | Mass Spectrometry |
| D000073216 | Mental Status and Dementia Tests |
| ID | Term |
|---|---|
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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