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Fatigue in Breast Cancer Survivors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00972400
First received: September 3, 2009
Last updated: October 7, 2009
Last verified: September 2009
History of Changes
  Purpose

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
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

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

Resource links provided by NLM:

U.S. FDA Resources

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 [ Designated as safety issue: No ]
  • Identification and quantification of serum biomarkers underlying biological pathways unique to cancer-related fatigue syndrome [ Designated as safety issue: No ]
  • Inter-relationships between variables [ Designated as safety issue: No ]

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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972400

Locations
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
Investigators
Principal Investigator: Ollie Minton, MD St George's, University of London
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00972400     History of Changes
Other Study ID Numbers: CDR0000647658, SGUL-PTF-Mechanisms, EU-20958
Study First Received: September 3, 2009
Last Updated: October 7, 2009
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013