Breast CancerNCT00972400
Fatigue in Breast Cancer Survivors
An observational study of Breast Cancer and Cancer Survivor, run by St George's, University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Cancer Survivor, Fatigue
- What is being tested?
- protein analysis, laboratory biomarker analysis and mass spectrometry
- Type of treatment
- Surgery or procedure
- How many people
- 96 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2009to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St. Georges, University of London
London, England, SW17 ORE
Ollie Minton, MD, 44-2087-252-620
About this study
Official title: Biological Mechanisms of Fatigue in Breast Cancer Survivors
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.
Read the 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.
- Being tested
- protein analysis, laboratory biomarker analysis, mass spectrometry, questionnaire administration, assessment of therapy complications
- Keywords
- psychosocial effects of cancer and its treatment, fatigue, cancer survivor, breast cancer
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein analysisGenetic
laboratory biomarker analysisOther
mass spectrometryOther
questionnaire administrationOther
assessment of therapy complicationsProcedure or surgery
cognitive assessmentProcedure or surgery
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Investigators
- Ollie Minton, MD, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972400
- Sponsor's protocol ID
- CDR0000647658
- Other IDs
- SGUL-PTF-Mechanisms, EU-20958
- Status last verified
- Sep 2009
- First submitted
- 3 Sep 2009
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Mechanisms of Fatigue in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT00972400
- Acronym / sponsor ID
- CDR0000647658
- Keywords
- psychosocial effects of cancer and its treatment, fatigue, cancer survivor, breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (estimated)
- First posted
- 4 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protein analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
| mass spectrometry | Other | – |
| questionnaire administration | Other | – |
| assessment of therapy complications | Procedure or surgery | – |
| cognitive assessment | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ollie Minton, MD principal investigator
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Cancer Survivor, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between fatigue severity; protein biomarkers; and measures of activity, sleep, mood, and cognition. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.