Psychometric Validation and Meaningful Within-Patient Change of the FAACT-5IASS in Patients With Cancer Cachexia
Author(s)
Jarjieh Fang, MPH1, Joshua A. Roth, MHA, PhD2, Magdalena A. Harrington, PhD3, John Groarke, MBBCH, MPH3, Susie M. Collins, MSc4, Joseph C. Cappelleri, PhD, MPH5, Andrew Bushmakin, MS5;
1Pfizer, New York, NY, USA, 2Pfizer, Seattle, WA, USA, 3Pfizer, Cambridge, MA, USA, 4Pfizer, Sandwich, United Kingdom, 5Pfizer, Groton, CT, USA
1Pfizer, New York, NY, USA, 2Pfizer, Seattle, WA, USA, 3Pfizer, Cambridge, MA, USA, 4Pfizer, Sandwich, United Kingdom, 5Pfizer, Groton, CT, USA
OBJECTIVES: The 5-item anorexia-related symptoms scale of the Functional Assessment of Anorexia-Cachexia Therapy (FAACT-5IASS) has demonstrated good internal consistency and responsiveness to changes in appetite among patients with non-small cell lung cancer (NSCLC). We aimed to further evaluate the psychometric properties of the FAACT-5IASS scale in patients with other tumors and cachexia using data from a recent randomized trial (as reported in Groarke et al, NEJM, 2024).
METHODS: We evaluated the measurement properties of the FAACT-5IASS using data from the ponsegromab randomized, double-blind, placebo-controlled, phase 2 study (ClinicalTrials.gov number=NCT05546476) in adult patients with NSCLC, colorectal, or pancreatic cancer and diagnosis of cachexia based on Fearon criteria. Properties included test-retest reliability, estimation of meaningful within-patient change (MWPC), known-group validity, ability to detect change, construct validity, and ceiling and floor effects.
RESULTS: The overall trial sample (n=187 patients) had median age=67 (IQR=60-74) years, 36.9% female, and 39.6%, 28.9%, and 31.6% with NSCLC, colorectal, and pancreatic cancer, respectively. The analyses include data from all available patients at each timepoint (n=174 patients at baseline). Acceptable test-retest reliability (ICC=0.78) and internal consistency (Cronbach’s alpha>0.70) were observed. No floor or ceiling effects were detected. Known-group validity was supported by significant differences in mean FAACT-5IASS scores between groups with “no appetite loss” and “very severe appetite loss”. Correlations between FAACT-5IASS and PGI-S (all above 0.6) supported convergent validity. Confirmatory Factor Analysis (CFA) supported the single factor measurement structure of the FAACT-5IASS (Bentler’s comparative fit index ≥ 0.95). MWPC values were 2.86 (PGI-C) and 3.58 (PGI-S) when a 2-point change in the anchor measure was used. Ability to detect change was supported by the approximately linear relationship between changes in PGI-S and FAACT-5IASS.
CONCLUSIONS: The FAACT-5IASS demonstrated robust psychometric properties and a MWPC of 2.86-3.58, supporting the use of the scale in research focused on evaluating appetite and anorexia symptoms in cancer cachexia patients.
METHODS: We evaluated the measurement properties of the FAACT-5IASS using data from the ponsegromab randomized, double-blind, placebo-controlled, phase 2 study (ClinicalTrials.gov number=NCT05546476) in adult patients with NSCLC, colorectal, or pancreatic cancer and diagnosis of cachexia based on Fearon criteria. Properties included test-retest reliability, estimation of meaningful within-patient change (MWPC), known-group validity, ability to detect change, construct validity, and ceiling and floor effects.
RESULTS: The overall trial sample (n=187 patients) had median age=67 (IQR=60-74) years, 36.9% female, and 39.6%, 28.9%, and 31.6% with NSCLC, colorectal, and pancreatic cancer, respectively. The analyses include data from all available patients at each timepoint (n=174 patients at baseline). Acceptable test-retest reliability (ICC=0.78) and internal consistency (Cronbach’s alpha>0.70) were observed. No floor or ceiling effects were detected. Known-group validity was supported by significant differences in mean FAACT-5IASS scores between groups with “no appetite loss” and “very severe appetite loss”. Correlations between FAACT-5IASS and PGI-S (all above 0.6) supported convergent validity. Confirmatory Factor Analysis (CFA) supported the single factor measurement structure of the FAACT-5IASS (Bentler’s comparative fit index ≥ 0.95). MWPC values were 2.86 (PGI-C) and 3.58 (PGI-S) when a 2-point change in the anchor measure was used. Ability to detect change was supported by the approximately linear relationship between changes in PGI-S and FAACT-5IASS.
CONCLUSIONS: The FAACT-5IASS demonstrated robust psychometric properties and a MWPC of 2.86-3.58, supporting the use of the scale in research focused on evaluating appetite and anorexia symptoms in cancer cachexia patients.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
PCR225
Topic
Patient-Centered Research
Topic Subcategory
Instrument Development, Validation, & Translation
Disease
SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity), SDC: Oncology