Assessing simple measures of patient-reported (PR) fatigue for oncology clinical trials: A pooled analysis of 3,915 patients

Abstract

9563 Background: Fatigue is a prevalent and debilitating symptom reported by cancer patients (pts) which compromises a pt's quality of life (QOL). This study examined the relationship between PR fatigue and QOL as well as cancer-related symptoms (CRS) in 43 North Central Cancer Treatment Group and Mayo Clinic Cancer Center clinical trials. Methods: 3,915 pts from 43 oncology clinical trials provided baseline fatigue data on a single-item 0–100 point scale. Pts' QOL assessment included a single-item overall QOL and associated QOL domains measured by numerical analogues, the Profile of Mood States (POMS), and PR symptom assessment measures. Associations between fatigue and QOL domains were assessed by Spearman correlation coefficients. Wilcoxon rank sum test compared QOL scores between pts with clinically deficient fatigue(CDF, score ≤50) vs. no clinically deficient fatigue (nCDF, score>50). Changes from baseline in fatigue and QOL were compared by Wilcoxon rank sum test with a 20-point change defined as clinically meaningful. Results: 38% of pts reported CDF at baseline and 45% of pts reported CDF at last assessment. Fatigue was only moderately correlated at best with overall QOL, pain, POMS, social and physical function (Spearman rho's of .27,.40, .56, .38 and .38 respectively). Pts with CDF averaged over 10 points lower overall QOL, pain, POMS, social, and physical function (see table below, all p<.0001) as well as worsening CRS including sleepiness, nausea, headache, abnormal sweating, trouble sleeping, dry mouth, and sexual dysfunction (all p<.001). Pts with 20+ points worsening in fatigue declined in overall QOL, physical function, pain and POMS (all p<.0001). Conclusions: Patients with CDF suffer greater deficits in QOL and CRS. Patients report fatigue as distinctly different from overall QOL, pain, physical, social, mood status and CRS. Fatigue appears with a broad spectrum of CRS clusters. Routine measurement and management of fatigue could impact QOL and treatment-related symptoms. [Table: see text] No significant financial relationships to disclose.