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22-02-2019 | Uitgave 6/2019

Quality of Life Research 6/2019

Comprehensive validation of the functional assessment of anorexia/cachexia therapy (FAACT) anorexia/cachexia subscale (A/CS) in lung cancer patients with involuntary weight loss

Tijdschrift:
Quality of Life Research > Uitgave 6/2019
Auteurs:
Heather L. Gelhorn, Katharine S. Gries, Rebecca M. Speck, Elizabeth M. Duus, Richard K. Bourne, Dimple Aggarwal, David Cella
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Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1007/​s11136-019-02135-7) contains supplementary material, which is available to authorized users.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Abstract

Purpose

Comprehensive (qualitative and quantitative) assessments of the 12-item functional assessment of anorexia/cachexia therapy (FAACT) anorexia/cachexia subscale (A/CS) and relevant subscales were undertaken for use in constructing potential endpoints in clinical trials of non-small cell lung cancer (NSCLC) with involuntary weight loss.

Methods

Eleven participants (≥ 18 years) from six clinical sites with a diagnosis of stage III unresectable or stage IV NSCLC and involuntary weight loss (either ≥ 5% body weight loss within six months prior to screening or screening BMI < 20 kg/m2) were interviewed to evaluate the content validity of the A/CS domain. A psychometric evaluation was conducted on the A/CS domain, and symptoms and concerns subscales, using data from previously completed phase III clinical trials (ROMANA1 [N = 474] and ROMANA2 [N = 488]).

Results

Anorexia-related symptoms were highly relevant to participants and had important impacts on their lives including energy levels, and physical, social, and psychological functioning. The majority of participants endorsed the A/CS domain items and found them to be easily understood, relevant, and comprehensive. Confirmatory factor analyses established that the A/CS symptoms and concerns subscales provided an acceptable fit as single factor models in ROMANA1 and ROMANA2. Reliability, validity, and responsiveness were established for the 12item A/CS domain, 5item anorexia symptoms subscale, and 4-item anorexia concerns subscale.

Conclusions

These scales have good content validity, favorable psychometric properties, and can be used for characterizing the effect of treatment on anorexia symptoms and/or anorexia-related concerns in patients with NSCLC.

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