Factors Correlated With Fatigue in Breast Cancer

• Conditions: Newly Diagnosed Breast Cancer; Surgery Programmed

• Registration Number: NCT01064427
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Status Verified: 2010-02
• Study First Submitted: 2010-02-05
• Study First Submitted QC: 2010-02-05
• Last Update Submitted: 2010-02-05
• Study First Posted: 2010-02-08
• Last Update Posted: 2010-02-08
• Primary Completion: 2012-09
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 557

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre-les-Nancy, Meurthe et Moselle, France

Centre Georges François Leclerc; 🇫🇷 Dijon, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France