Evaluation of the Correlation between fatigue and quality of life in patients with solid tumour, malignant lymphoma or multiple myeloma and treated with Binocrit® for a chemotherapy-induced anaemia (CIROCO)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  BINOCRIT
• Study drug International non-proprietary name (INN) or common name:
  EPOETIN ALFA
• Anatomical Therapeutic Chemical (ATC) code:
  (B03XA01) erythropoietin

  erythropoietin
• Medical condition to be studied:
  Anaemia

  Fatigue

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  965

Study design details

• Main study objective:
  The main objective of the study is to determine the correlation between fatigue,measured using a Visual Analog Scale (VAS), and Quality of Life, evaluated using the EORTC QLQ C30 questionnaire, perceived by patients undergoing chemotherapy for a solid tumour,malignant lymphoma, multiple myeloma presenting with a chemotherapy-induced anaemia and receiving Binocrit®.
• Outcomes:
  The evaluation of the correlation at T0 (inclusion), T1 (follow-up) and T2 (end of follow-up), between the fatigue perceived by the patient and measured using a VAS and the QL score from the EORTC QLQ-C30 questionnaire. *Correlation coefficient between: ; -the change in fatigue and the change in QL between T0 and T1 and between T0 and T2 -haemoglobin and the QL -haemoglobin and VAS perceived by patient; *Patient's VAS fatigue perceived by the physician; *Concordance between the VAS (patient and physician); *Procedure for using Binocrit® based on haemoglobin ; *Factors associated with improved fatigue and QL
• Data analysis plan:
  Statistical tests will be bilateral and a significance threshold of 5% will be used. The raw correlation between the two quantitative variables, fatigue value estimated value and QL score, will be calculated using the Pearson correlation coefficient and will be presented alongside its 95% CI. ; If the distributions do not follow a normal distribution or if outliers are observed, the use of the Spearman correlation coefficient will be preferred. ; The null hypotheses H0 r=0, r=0.10 and r=0.3 will be tested at a risk level of α = 0.05 in a bilateral situation in order to test respectively if the correlation level is zero, weak or moderate.; The differences observed between the three evaluation timepoints (T0, T1 and T2) will be discussed.; Unless otherwise specified (i.e. calculation of sub-scores in the QL questionnaire, multivariate analyses to look for predictive factors of fatigue and QL improvement), missing data will not be replaced.