Factors Correlated With Fatigue in Breast Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Newly Diagnosed Breast Cancer, Surgery Programmed

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chemotherapy group<br>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<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, fatigue, adjuvant chemotherapy, quality of life