General population reference values for the Functional Assessment of Cancer Therapy‐Lung and PROMIS‐29

• Published in: Cancer medicine (Malden, MA) Vol. 12; no. 11; pp. 12765 - 12776
• Main Authors: Mohindra, Nisha A., Peipert, John Devin, Blum, Steven I., Shaw, James W., Penrod, John R., Cella, David
• Format: Journal Article
• Language: English
• Published: United States John Wiley & Sons, Inc 01-06-2023; John Wiley and Sons Inc; Wiley
• Subjects: Adult; Cancer therapies; Clinical trials; Cognitive ability; Comorbidity; Coronaviruses; COVID-19; COVID-19 - epidemiology; Gender; Humans; Lung; Lung cancer; Lung Neoplasms - diagnosis; Lung Neoplasms - epidemiology; Lung Neoplasms - therapy; Pandemics; patient‐reported outcomes; Population; Quality of Life - psychology; Questionnaires; Reference Values; Surveys and Questionnaires; United States > US; lung cancer; patient-reported outcomes
• ISSN: 2045-7634; 2045-7634
• DOI: 10.1002/cam4.5920

Background
Therapeutic advances in lung cancer have turned attention toward patient‐reported outcome measures (PROMs) as important clinical outcomes. The Functional Assessment of Cancer Therapy‐Lung (FACT‐L) is a common endpoint in lung cancer trials. This study calculated FACT‐L reference values for the United States (US) general population.
Methods
Adults from the US general population (N = 2001) were surveyed between September 2020 and November 2020. Surveys contained 126 questions, including the FACT‐L [36 items; FACT‐G and four subscales (Physical Well‐Being [PWB], Social Well‐Being [SWB], Emotional Well‐Being [EWB], and Functional Well‐Being [FWB]) and the Lung Cancer Subscale (LCS), and a Trial Outcome Index (TOI)]. Reference values for each FACT‐L scale were calculated with means for the total sample and separately for participants with: no comorbidities, COVID‐19 as only comorbidity, no COVID‐19.
Results
In the total sample, the reference scores were as follows: PWB = 23.1; SWB = 16.8; EWB = 18.5; FWB = 17.6; FACT‐G = 76.0; LCS = 23.0, TOI = 63.7, and FACT‐L Total = 99.0. Scores were lower for those reporting a prior diagnosis of COVID‐19, especially for SWB (15.7) and FWB (15.3). SWB scores were lower than previous references values.
Conclusions
These data provide US general adult population reference value set for FACT‐L. While some of the subscale results were lower than those found in the reference data for other PROMs, these data were obtained in a more contemporaneous time frame juxtaposed with the COVID‐19 pandemic and may represent a new peri‐pandemic norm. Thus, these reference values will be useful for future clinical research.
This study provides reference values for FACT‐L and its subscales from the general population, with most scores similar to those from previous references value sets. These reference values will be useful for future clinical research and will help us understand the extent of burden related to treatment relative to the population at large.