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

Author:

Mohindra Nisha A.12ORCID,Peipert John Devin3ORCID,Blum Steven I.4,Shaw James W.4,Penrod John R.4,Cella David3

Affiliation:

1. Division of Hematology and Oncology, Department of Medicine Northwestern University Feinberg School of Medicine Chicago Illinois USA

2. Robert H. Lurie Comprehensive Cancer Center Northwestern University Chicago Illinois USA

3. Department of Medical Social Sciences Northwestern University Feinberg School of Medicine Chicago Illinois USA

4. Bristol Myers Squibb Princeton New Jersey USA

Abstract

AbstractBackgroundTherapeutic 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.MethodsAdults 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.ResultsIn 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.ConclusionsThese 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.

Publisher

Wiley

Subject

Cancer Research,Radiology, Nuclear Medicine and imaging,Oncology

Reference23 articles.

1. Cancer Statistics, 2021

2. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries

3. The Effect of Advances in Lung-Cancer Treatment on Population Mortality

4. https://www.fda.gov/regulatory‐information/search‐fda‐guidance‐documents/patient‐reported‐outcome‐measures‐use‐medical‐product‐development‐support‐labeling‐claims. Accessed November 11 2021

5. Collecting patient‐reported outcomes in cancer clinical trials;Kuehn BM;JAMA,2021

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