Clinical trial · Observational
Factors Correlated With Fatigue in Breast Cancer
Factors Correlated With Fatigue in Breast Cancer Patients Before, During and After Adjuvant Chemotherapy
NCT01064427CI-TRIAL-00003117FATSEINunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Newly Diagnosed Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Surgery Programmed | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- 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.
- label
- 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.
Primary outcomes (1)
- measure
- The Multidimensional Fatigue Inventory (MFI-20) questionnaire is used to assess patient's fatigue.
- timeFrame
- Breast cancer patients complete the questionnaires before surgery and at several times depending on their adjuvant treatment
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRotonda 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 21078419