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Fatigue in Breast Cancer Survivors

Primary Purpose

Breast Cancer, Cancer Survivor, Fatigue

Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
protein analysis
laboratory biomarker analysis
mass spectrometry
questionnaire administration
assessment of therapy complications
cognitive assessment
quality-of-life assessment
Sponsored by
St George's, University of London
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Breast Cancer focused on measuring psychosocial effects of cancer and its treatment, fatigue, cancer survivor, breast cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • St. Georges, University of LondonRecruiting

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
September 3, 2009
Last Updated
August 23, 2013
Sponsor
St George's, University of London
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1. Study Identification

Unique Protocol Identification Number
NCT00972400
Brief Title
Fatigue in Breast Cancer Survivors
Official Title
Biological Mechanisms of Fatigue in Breast Cancer Survivors
Study Type
Observational

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
St George's, University of London

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cancer Survivor, Fatigue, Psychosocial Effects of Cancer and Its Treatment
Keywords
psychosocial effects of cancer and its treatment, fatigue, cancer survivor, breast cancer

7. Study Design

Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
protein analysis
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
mass spectrometry
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
assessment of therapy complications
Intervention Type
Procedure
Intervention Name(s)
cognitive assessment
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Relationship between fatigue severity; protein biomarkers; and measures of activity, sleep, mood, and cognition
Title
Identification and quantification of serum biomarkers underlying biological pathways unique to cancer-related fatigue syndrome
Title
Inter-relationships between variables

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ollie Minton, MD
Organizational Affiliation
St George's, University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Georges, University of London
City
London
State/Province
England
ZIP/Postal Code
SW17 ORE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ollie Minton, MD
Phone
44-2087-252-620

12. IPD Sharing Statement

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Fatigue in Breast Cancer Survivors

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