Factors Correlated With Fatigue in Breast Cancer

Newly Diagnosed Breast Cancer Clinical Trial

— FATSEIN  

Official title:

Factors Correlated With Fatigue in Breast Cancer Patients Before, During and After Adjuvant Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01064427
• Other study ID #: 08-FATQV
• Status: Recruiting
• Phase: N/A
• First received: February 5, 2010
• Last updated: February 5, 2010
• Start date: July 2008
• Est. completion date: September 2012

Study information

• Verified date: February 2010
• Source: Central Hospital, Nancy, France
• Contact: Rotonda Christine, PhD student
• Phone: 3 83 59 85 74
• Email: christine.rotonda[@]hotmail.fr
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 557
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Newly Diagnosed Breast Cancer
• Surgery Programmed

Locations

Country	Name	City	State
France	Centre Georges François Leclerc	Dijon
France	Centre Paul Strauss	Strasbourg
France	Centre Alexis Vautrin	Vandoeuvre-les-Nancy	Meurthe et Moselle

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No