title: Cancer-related fatigue management: evaluation of a patient education program with a large-scale randomised controlled trial, the PEPs fatigue study.
abstract: BACKGROUND
  To assess the efficacy of a patient educational program built according to guidelines that aims at reducing cancer-related fatigue (CRF).
  
  
  METHODS
  Randomised controlled trial, multicentre, comparing a patient education program, vs the standard of care. Patients were adult cancer outpatients with any tumour site. The primary outcome was fatigue severity assessed with a visual analogical scale (VAS), between the day of randomisation and week 7. Secondary outcomes were fatigue assessed with other scales, health-related quality of life, anxiety and depression. The time to fatigue severity deterioration was assessed. Analyses were performed in a modified intent-to-treat way, that is, including all patients with at least one baseline and 1 week 7 score.
  
  
  RESULTS
  A total of 212 patients were included. Fatigue severity assessment was made on 79 patients in the experimental group and 65 in the control group. Between randomisation and week 7, the fatigue (VAS) improved by 0.96 (2.85) points in the experimental group vs 1.63 (2.63) points in the control group (P=0.15). No differences with the secondary outcomes were highlighted between two groups. No other factors were found to be associated with fatigue severity deterioration.
  
  
  CONCLUSIONS
  Despite rigorous methodology, this study failed to highlight the program efficacy in fatigue reduction for cancer patients. Other assessment tools should be developed to measure the effect of the program on CRF and behaviour. The implementation of the program should also be explored in order to identify its mechanisms and longer-term impact.
authors.affiliation: Public Health Department, Hygée Centre, Lucien Neuwirth Cancer Institute, Saint Priest en Jarez, France.|Quality Safety Performance in Health (HESPER) EA7425, Lyon 1 University, Lyon, France.|Inserm, Clinical Investigation Center 1408, Saint-Etienne 42055, France.
authors.forename: A
authors.initials: A
authors.lastname: Bourmaud
authors.affiliation: French National Platform Quality of Life and Cancer, Besançon, France.|Methodology and Quality of Life Unit in Cancer, INSERM UMR 1098, University Hospital of Besançon, Besançon, France.
authors.forename: A
authors.initials: A
authors.lastname: Anota
authors.affiliation: Public Health Department, Hygée Centre, Lucien Neuwirth Cancer Institute, Saint Priest en Jarez, France.|Radiotherapy Department, Lucien Neuwirth Cancer Institut, Saint Priest en Jarez, France.
authors.forename: C
authors.initials: C
authors.lastname: Moncharmont
authors.affiliation: Public Health Department, Hygée Centre, Lucien Neuwirth Cancer Institute, Saint Priest en Jarez, France.|Inserm, Clinical Investigation Center 1408, Saint-Etienne 42055, France.
authors.forename: F
authors.initials: F
authors.lastname: Tinquaut
authors.affiliation: Public Health Department, Hygée Centre, Lucien Neuwirth Cancer Institute, Saint Priest en Jarez, France.|Inserm, Clinical Investigation Center 1408, Saint-Etienne 42055, France.
authors.forename: M
authors.initials: M
authors.lastname: Oriol
authors.affiliation: Medical Oncology Department, Lyon-Sud Lyon-Sud teaching hospital, Lyon, France.
authors.forename: V
authors.initials: V
authors.lastname: Trillet-Lenoir
authors.affiliation: Direction of Clinical Research and of Innovation, Léon Bérard Cancer Center, Lyon, France.
authors.forename: A
authors.initials: A
authors.lastname: Bajard
authors.affiliation: French National Platform Quality of Life and Cancer, Besançon, France.
authors.forename: S
authors.initials: S
authors.lastname: Parnalland
authors.affiliation: French National Platform Quality of Life and Cancer, Besançon, France.|INSERM, CIC-EC CIE6, Nancy, France CHU Nancy, Clinical Epidemiology and Evaluation Department, Nancy, France.
authors.forename: C
authors.initials: C
authors.lastname: Rotonda
authors.affiliation: French National Platform Quality of Life and Cancer, Besançon, France.|Methodology and Quality of Life Unit in Cancer, INSERM UMR 1098, University Hospital of Besançon, Besançon, France.
authors.forename: F
authors.initials: F
authors.lastname: Bonnetain
authors.affiliation: Direction of Clinical Research and of Innovation, Léon Bérard Cancer Center, Lyon, France.
authors.forename: D
authors.initials: D
authors.lastname: Pérol
authors.affiliation: Public Health Department, Hygée Centre, Lucien Neuwirth Cancer Institute, Saint Priest en Jarez, France.|Quality Safety Performance in Health (HESPER) EA7425, Lyon 1 University, Lyon, France.|Inserm, Clinical Investigation Center 1408, Saint-Etienne 42055, France.
authors.forename: F
authors.initials: F
authors.lastname: Chauvin
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D001007:Anxiety / Q000209:etiology / Q000517:prevention & control*; D016022:Case-Control Studies; D003863:Depression / Q000209:etiology / Q000517:prevention & control*; D019468:Disease Management; D005221:Fatigue / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009369:Neoplasms / Q000150:complications* / Q000473:pathology / Q000628:therapy; D010147:Pain Measurement; D010353:Patient Education as Topic / Q000379:methods*; D011379:Prognosis; D011788:Quality of Life; D012054:Reinforcement, Psychology; D015996:Survival Rate