Factors Correlated With Fatigue in Breast Cancer (FATSEIN)

February 5, 2010 updated by: Central Hospital, Nancy, France

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

557

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21 000
        • Recruiting
        • Centre Georges François Leclerc
        • Contact:
        • Principal Investigator:
          • Bonnetain Franck
      • Strasbourg, France, 67 000
        • Recruiting
        • Centre Paul Strauss
        • Contact:
        • Principal Investigator:
          • Velten Michel
    • Meurthe et Moselle
      • Vandoeuvre-les-Nancy, Meurthe et Moselle, France, 54 511
        • Recruiting
        • Centre Alexis Vautrin
        • Contact:
        • Principal Investigator:
          • Conroy Thierry, PU-PH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Multidimensional Fatigue Inventory (MFI-20) questionnaire is used to assess patient's fatigue.
Time Frame: Breast cancer patients complete the questionnaires before surgery and at several times depending on their adjuvant treatment
Breast cancer patients complete the questionnaires before surgery and at several times depending on their adjuvant treatment

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

February 5, 2010

First Submitted That Met QC Criteria

February 5, 2010

First Posted (Estimate)

February 8, 2010

Study Record Updates

Last Update Posted (Estimate)

February 8, 2010

Last Update Submitted That Met QC Criteria

February 5, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-FATQV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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