Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
557 participants
OBSERVATIONAL
2008-07-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Chemotherapy group
Breast cancer patients treated by adjuvant chemotherapy after their surgery. The time points of data collection are before the start of the first, second, fourth and sixth cycle of chemotherapy. If patients are treated by radiotherapy after the chemotherapy, there are 2 measurements points pre- and post radiotherapy.The others measurement points are at 12,18 and 24 months after surgery.
No interventions assigned to this group
No chemotherapy group
Breast cancer patients no treated by adjuvant chemotherapy after their surgery. For patients treated by radiotherapy after surgery, there are 2 measurement points pre- and post radiotherapy. The others measurement points are at 4,6,7,8,12,18 and 24 months after surgery.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* newly diagnosed with stage I-IIIA breast adenocarcinoma
* have undergone surgery
* WHO performance status score equal or lower than 2
* able to provide informed consent
* speak French and able to complete self-report questionnaires
Exclusion Criteria
* bilateral breast cancer
* metastatic breast cancer
* patients who received neoadjuvant chemotherapy
* known psychiatric disease or dementia
* no previous history of cancer
18 Years
80 Years
FEMALE
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Inserm CIC-EC CIE6, CHU Nancy
Principal Investigators
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Guillemin Francis, PU-PH
Role: PRINCIPAL_INVESTIGATOR
Inserm, CIC-EC CIE6, Nancy; CHU Nancy
Conroy Thierry, PU-PH
Role: PRINCIPAL_INVESTIGATOR
Centre Alexis Vautrin, Department of Medical Oncology, Vandoeuvre-les-Nancy, France
Locations
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Centre Alexis Vautrin
Vandœuvre-lès-Nancy, Meurthe et Moselle, France
Centre Georges François Leclerc
Dijon, , France
Centre Paul Strauss
Strasbourg, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Rotonda C, Guillemin F, Bonnetain F, Conroy T. Factors correlated with fatigue in breast cancer patients before, during and after adjuvant chemotherapy: the FATSEIN study. Contemp Clin Trials. 2011 Mar;32(2):244-9. doi: 10.1016/j.cct.2010.11.007. Epub 2010 Nov 13.
Other Identifiers
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08-FATQV
Identifier Type: -
Identifier Source: org_study_id
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