Systematic Monitoring and Treatment of Physical Symptoms to Alleviate Fatigue in Patients With Advanced Cancer: A Randomized Controlled Trial

Purpose Several guidelines on the treatment of cancer-related fatigue recommend optimizing treatment of accompanying symptoms. However, evidence for this recommendation from randomized clinical trials is lacking. We investigated whether monitoring and protocolized treatment of physical symptoms alleviates fatigue. Patients and Methods In all, 152 fatigued patients with advanced cancer were randomly assigned to protocolized patient-tailored treatment (PPT) of symptoms or care as usual. The PPT group had four appointments with a nurse who assessed nine symptoms on a 0 to 10 numeric rating scale (NRS). Patients received a nonpharmacologic intervention for symptoms with a score >= 1 and a medical intervention for symptoms with a score >= 4. Fatigue dimensions, fatigue NRS score, interference of fatigue with daily life, symptom burden, quality of life, anxiety, and depression were measured at baseline and after 1, 2, and 3 months. Differences between the groups over time were assessed by using mixed modeling. Results Seventy-six patients were randomly assigned to each study arm. Mean age was 58 +/- 10 years, 57% were female, and 65% were given palliative chemotherapy. We found significant improvements over time in favor of PPT for the primary outcome general fatigue (P = .01), with significant group differences at month 1 (effect size, 0.26; P = .007) and month 2 (effect size, 0.35; P = .005). Improvements in favor of PPT were also found for the following secondary outcomes: fatigue dimensions reduced activity and reduced motivation, fatigue NRS, symptom burden, interference of fatigue with daily life, and anxiety (all P <= .03). Conclusion In fatigued patients with advanced cancer, nurse-led monitoring and protocolized treatment of physical symptoms is effective in alleviating fatigue. J Clin Oncol 31:716-723. (c) 2013 by American Society of Clinical Oncology