title: Brief versions of the FACIT-fatigue and FAACT subscales for patients with non-small cell lung cancer cachexia.
abstract: OBJECTIVE
  Cancer anorexia-cachexia syndrome (CACS) is common in advanced cancer patients and associated with weight loss, fatigue, impaired quality of life (QoL), and poor prognosis. The goal of this project was to identify the most responsive items from two QoL measures in the ROMANA 2 (NCT01387282) phase III global study evaluating anamorelin HCl in the treatment of non-small cell lung cancer (NSCLC) cachexia: the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and the Functional Assessment of Anorexia/Cachexia Therapy (FAACT).
  
  
  METHODS
  In the ROMANA 2 trial, 477 patients with unresectable stage III or IV NSCLC and cachexia were to be enrolled and randomized (2:1) to receive anamorelin HCl or placebo once daily for 12 weeks. All 203 patients who reached the week 12 visit at the time of data analysis were included. Co-primary endpoints were change from baseline in lean body mass and handgrip strength. QoL was a secondary outcome with FACIT-F and FAACT questionnaires administered at baseline and at weeks 3, 6, 9, and 12.
  
  
  RESULTS
  Two 4-item scales (fatigue/activity and appetite/eating) from the FACIT-F and FAACT questionnaires, respectively, demonstrated good internal consistency reliability, validity, and responsiveness (also referred to as the Simplified Evaluation of Fatigue (SEF) and Simplified Evaluation of Appetite (SEA), respectively). The estimated important difference for each scale was 1-2 points.
  
  
  CONCLUSIONS
  These brief scales provide the psychometric properties necessary to promote future research in NSCLC patients with CACS. Additional work should examine the clinical utility of these scales and their impact on treatment decision-making.
authors.affiliation: Department of Medical Social Sciences, Feinberg School of Medicine at Northwestern University, 633 North St. Clair, 19th Floor, Chicago, IL, 60611, USA, j-salsman@northwestern.edu.
authors.forename: John M
authors.initials: JM
authors.lastname: Salsman
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Beaumont
authors.forename: Katy
authors.initials: K
authors.lastname: Wortman
authors.forename: Ying
authors.initials: Y
authors.lastname: Yan
authors.forename: John
authors.initials: J
authors.lastname: Friend
authors.forename: David
authors.initials: D
authors.lastname: Cella
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000855:Anorexia / Q000175:diagnosis* / Q000188:drug therapy / Q000209:etiology; D001066:Appetite / Q000187:drug effects; D019167:Appetite Stimulants / Q000627:therapeutic use; D002100:Cachexia / Q000175:diagnosis* / Q000188:drug therapy / Q000209:etiology; D002289:Carcinoma, Non-Small-Cell Lung / Q000150:complications* / Q000188:drug therapy; D005221:Fatigue / Q000175:diagnosis* / Q000209:etiology / Q000628:therapy; D005260:Female; D018737:Hand Strength; D006305:Health Status Indicators; D006801:Humans; D006834:Hydrazines / Q000627:therapeutic use; D008175:Lung Neoplasms / Q000150:complications* / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000627:therapeutic use; D010919:Placebos; D011594:Psychometrics; D011788:Quality of Life; D054440:Receptors, Ghrelin / Q000819:agonists; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D015431:Weight Loss
chemical_list: D019167:Appetite Stimulants; D006834:Hydrazines; D009842:Oligopeptides; D010919:Placebos; D054440:Receptors, Ghrelin; C000593861:anamorelin