Fatigue in Breast Cancer Survivors

• Conditions: Breast Cancer; Cancer Survivor; Fatigue; Psychosocial Effects of Cancer and Its Treatment

• Registration Number: NCT00972400
• Lead Sponsor: St George's, University of London

Brief Summary

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.

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-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 Timeline

• Study Start: 2009-01
• Status Verified: 2009-09
• Study First Submitted: 2009-09-03
• Study First Submitted QC: 2009-09-03
• Study First Posted: 2009-09-04
• Primary Completion: 2011-01
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

St. Georges, University of London; 🇬🇧 London, England, United Kingdom