Factors Correlated With Fatigue in Breast Cancer (FATSEIN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Central Hospital, Nancy, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01064427
First received: February 5, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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.


Condition
Newly Diagnosed Breast Cancer
Surgery Programmed

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Factors Correlated With Fatigue in Breast Cancer Patients Before, During and After Adjuvant Chemotherapy

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 557
Study Start Date: July 2008
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064427

Contacts
Contact: Rotonda Christine, PhD student 3 83 59 85 74 ext +33 christine.rotonda@hotmail.fr

Locations
France
Centre Alexis Vautrin Recruiting
Vandoeuvre-les-Nancy, Meurthe et Moselle, France, 54 511
Contact: Rotonda Christine, PhD student    3 83 59 85 74 ext +33    christine.rotonda@hotmail.fr   
Principal Investigator: Conroy Thierry, PU-PH         
Centre Georges François Leclerc Recruiting
Dijon, France, 21 000
Contact: Rotonda Christine, PhD student    3 83 59 85 74 ext +33    christine.rotonda@hotmail.fr   
Principal Investigator: Bonnetain Franck         
Centre Paul Strauss Recruiting
Strasbourg, France, 67 000
Contact: Rotonda Christine, PhD student    3 83 59 85 74 ext +33    christine.rotonda@hotmail.fr   
Principal Investigator: Velten Michel         
Sponsors and Collaborators
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
  More Information

No publications provided by Central Hospital, Nancy, France

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francis Guillemin, PU-PH, Inserm CIC-EC CIE6, CHU Nancy
ClinicalTrials.gov Identifier: NCT01064427     History of Changes
Other Study ID Numbers: 08-FATQV
Study First Received: February 5, 2010
Last Updated: February 5, 2010
Health Authority: France: Institutional Ethical Committee

Keywords provided by Central Hospital, Nancy, France:
breast cancer
fatigue
adjuvant chemotherapy
quality of life

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Breast Diseases
Neoplasms
Neoplasms by Site
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on October 22, 2014