Factors Correlated With Fatigue in Breast Cancer (FATSEIN)

Central Hospital, Nancy, France

Status: Unknown

Conditions: Surgery Programmed; Newly Diagnosed Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01064427

08-FATQV

Details and patient eligibility

About

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.

Enrollment: 557 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

557 participants in 2 patient groups

Chemotherapy group

Description:

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

Description:

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.