title: Clinically important improvement in the intensity of fatigue in patients with advanced cancer.
abstract: Cancer-related fatigue (CRF) is the most common symptom experienced by patients with cancer. Clinically important improvement in the intensity of fatigue in palliative care patients has not been well established. We reviewed the data from 3 clinical trials of fatigue in 194 patients receiving palliative care treatment. Patients completed the Functional Assessment for Chronic Illness Therapy Fatigue (FACIT-F) and Edmonton Symptom Assessment System (ESAS) at baseline and day 8 and their global perception of fatigue improvement (Global benefit score [GBS]: 1 = not beneficial, 7 = greatly important] during day 8. A GBS of 4 or more (moderate improvement, consistently beneficial) was considered a clinically significant improvement. Change scores in the ESAS and FACIT-F from baseline to day 8 were compared to the GBS greater than 4. Receiver-operating characteristic curves were also derived for ESAS and FACIT-F change scores for a GBS greater than 4, greater than 5, and greater than 6. Results showed the mean patient age was 56 (+/-12) years, and 37% were men. A reduction of approximately 10 points in FACIT-F (sensitivity = 73%, specificity = 78%, area under the curve = 0.82) and 4 points in ESAS fatigue (sensitivity = 66%, specificity = 72%, area under the curve = 0.78) score was best able to predict a clinically important improvement (GBS >/= 4). We were able to characterize the relationship between FACIT-F and ESAS scores and patients' global perception of improvement but further studies are needed to validate our findings.
authors.affiliation: Department of Palliative Care and Rehabilitation Medicine, University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030, USA. ebruera@mdanderson.org
authors.forename: Shantan
authors.initials: S
authors.lastname: Reddy
authors.forename: Eduardo
authors.initials: E
authors.lastname: Bruera
authors.forename: Ellen
authors.initials: E
authors.lastname: Pace
authors.forename: Karen
authors.initials: K
authors.lastname: Zhang
authors.forename: Cielito C
authors.initials: CC
authors.lastname: Reyes-Gibby
mesh_terms: D018450:Disease Progression; D005221:Fatigue / Q000188:drug therapy / Q000209:etiology* / Q000503:physiopathology; D005260:Female; D006305:Health Status Indicators; D006306:Health Surveys; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000503:physiopathology; D010166:Palliative Care; D011581:Psychological Tests; D011594:Psychometrics; D011788:Quality of Life; D012372:ROC Curve; D012307:Risk Factors; D012720:Severity of Illness Index