NCT00972400

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Last Updated

August 26, 2013

Status Verified

September 1, 2009

Enrollment Period

2 years

First QC Date

September 3, 2009

Last Update Submit

August 23, 2013

Conditions

Breast CancerCancer SurvivorFatiguePsychosocial Effects of Cancer and Its Treatment

Keywords

psychosocial effects of cancer and its treatmentfatiguecancer survivorbreast cancer

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

protein analysisGENETIC
laboratory biomarker analysisOTHER
mass spectrometryOTHER
questionnaire administrationOTHER
assessment of therapy complicationsPROCEDURE
cognitive assessmentPROCEDURE
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

St. Georges, University of London

London, England, SW17 ORE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsFatigue

Interventions

Mass SpectrometryMental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chemistry Techniques, AnalyticalInvestigative TechniquesNeuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Ollie Minton, MD

    St George's, University of London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 3, 2009

First Posted

September 4, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2011

Last Updated

August 26, 2013

Record last verified: 2009-09

Locations

GB(1)