Factors Correlated With Fatigue in Breast Cancer

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01064427

Acronym

FATSEIN

Enrollment

557

Registered

2010-02-08

Start date

2008-07-31

Completion date

2012-09-30

Last updated

2010-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly Diagnosed Breast Cancer, Surgery Programmed

Keywords

breast cancer, fatigue, adjuvant chemotherapy, quality of life

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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.	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

Countries

France

Contacts

Primary ContactRotonda Christine, PhD student

christine.rotonda@hotmail.fr3 83 59 85 74

Outcome results