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.

Cancer-related fatigue: ESMO Clinical Practice Guidelines for diagnosis and treatment

“…There have been several studies on the evaluation of CBT, but fatigue has been investigated as the primary outcome in just a few of them. 81,84,87 In these studies, a clinically significant decrease in fatigue severity and functional impairment has been demonstrated.…”

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“…who suggest that that associated symptoms such as pain, dyspnea, depression, or nausea must be assessed and managed in all patients expressing fatigue because such multidimensional management rises the possibility of fatigue improvement. Although, the current study not matching with the study conduct on France build based on NCCN guidelines byBourmaud et al (2017) who reported that no impact of the program was highlighted on the patient's outcomes.…”

Recommendation for supportive care in patients receiving concurrent chemotherapy and radiotherapy for lung cancer

“…These programs can be helpful to develop strategies with the patients to handle fatigue-promoting or energy-consuming activities. 76…”