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The aim of this study is to identify the determinants of cancer-related fatigue, and the long-term effect of the different adjuvants treatments will be explored. A prospective longitudinal study in women diagnosed for the first time with stage I-III breast cancer and who have undergone surgery, has been designed to meet the study aims.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| The Multidimensional Fatigue Inventory (MFI-20) questionnaire is used to assess patient's fatigue. | Breast cancer patients complete the questionnaires before surgery and at several times depending on their adjuvant treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaires regarding personality traits (LOT "Life Orientation Test" and the trait-version of the STAI "State Trait Anxiety instrument"), Quality of life questionnaire(EORTC QLQ-C30), and the state-version of the STAI will be also completed. | For the LOT and the trait-version of the STAI: only before the surgery, for the QLQ-C30: before surgery and several times during adjuvant treatment and for the state-version of the STAI: several times during adjuvant treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Recruitment began in September 2008 and is planned over a 24-month period. Participants with breast cancer are recruited from three French cancer centers, the Alexis Vautrin anti-cancer center of Vandoeuvre-les-Nancy, the Georges-François Leclerc anti-cancer center of Dijon and the Paul Strauss anti-cancer center of Strasbourg, France. Participation to study is proposed to all women with newly diagnosed breast cancer the day preceeding surgery.Included patients are asked to complete the questionnaires several times.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rotonda Christine, PhD student | Contact | 3 83 59 85 74 | +33 | christine.rotonda@hotmail.fr |
| Name | Affiliation | Role |
|---|---|---|
| Guillemin Francis, PU-PH | Inserm, CIC-EC CIE6, Nancy; CHU Nancy | Principal Investigator |
| Conroy Thierry, PU-PH | Centre Alexis Vautrin, Department of Medical Oncology, Vandoeuvre-les-Nancy, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Alexis Vautrin | Recruiting | Vandœuvre-lès-Nancy | Meurthe et Moselle | 54 511 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21078419 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Centre Georges François Leclerc | Recruiting | Dijon | 21 000 | France |
|
| Centre Paul Strauss | Recruiting | Strasbourg | 67 000 | France |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |