NCT01064427

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
557

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2008

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

February 8, 2010

Status Verified

February 1, 2010

Enrollment Period

4.2 years

First QC Date

February 5, 2010

Last Update Submit

February 5, 2010

Conditions

Newly Diagnosed Breast CancerSurgery Programmed

Keywords

breast cancerfatigueadjuvant chemotherapyquality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

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 Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, Meurthe et Moselle, 54 511, France

RECRUITING

Centre Georges François Leclerc

Dijon, 21 000, France

RECRUITING

Centre Paul Strauss

Strasbourg, 67 000, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 21078419DERIVED

MeSH Terms

Conditions

Breast NeoplasmsFatigue

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rotonda Christine, PhD student

CONTACT

3 83 59 85 74christine.rotonda@hotmail.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 5, 2010

First Posted

February 8, 2010

Study Start

July 1, 2008

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

February 8, 2010

Record last verified: 2010-02

Locations

FR(3)