Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Fatigue in Breast Cancer Survivors

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: September 3, 2009
Last updated: August 23, 2013
Last verified: September 2009

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 Intervention
Breast Cancer
Cancer Survivor
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

Study Type: Observational
Official Title: Biological Mechanisms of Fatigue in Breast Cancer Survivors

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome 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

Estimated Enrollment: 96
Study Start Date: January 2009
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • Sufficient English language skills
  • No significant cognitive impairment
  • No concurrent severe combined immunodeficiency disease


  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00972400

United Kingdom
St. Georges, University of London Recruiting
London, England, United Kingdom, SW17 ORE
Contact: Ollie Minton, MD    44-2087-252-620      
Sponsors and Collaborators
St George's, University of London
Principal Investigator: Ollie Minton, MD St George's, University of London
  More Information Identifier: NCT00972400     History of Changes
Other Study ID Numbers: CDR0000647658
Study First Received: September 3, 2009
Last Updated: August 23, 2013

Keywords provided by National Cancer Institute (NCI):
psychosocial effects of cancer and its treatment
cancer survivor
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Signs and Symptoms processed this record on May 24, 2017