Clinical trial NCT01064427: Factors Correlated With Fatigue in Breast Cancer
Official title: Factors Correlated With Fatigue in Breast Cancer Patients Before, During and After Adjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Newly Diagnosed Breast Cancer
Surgery Programmed
Keywords: breast cancer
fatigue
adjuvant chemotherapy
quality of life
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2010-02-08
Enrollment: 557
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* aged 18 years and older
* 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:

* pregnancy
* bilateral breast cancer
* metastatic breast cancer
* patients who received neoadjuvant chemotherapy
* known psychiatric disease or dementia
* no previous history of cancer

Primary outcomes:
measure: The Multidimensional Fatigue Inventory (MFI-20) questionnaire is used to assess patient's fatigue.
timeFrame: Breast cancer patients complete the questionnaires before surgery and at several times depending on their adjuvant treatment
Secondary outcomes:
measure: 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.
timeFrame: 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
Other outcomes:
Locations:
city: Vandoeuvre-les-Nancy
country: France
facility: Centre Alexis Vautrin
state: Meurthe et Moselle
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Strasbourg
country: France
facility: Centre Paul Strauss
Study officials:
affiliation: Inserm, CIC-EC CIE6, Nancy; CHU Nancy
name: Guillemin Francis, PU-PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Alexis Vautrin, Department of Medical Oncology, Vandoeuvre-les-Nancy, France
name: Conroy Thierry, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.