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- Title
Comprehensive validation of the functional assessment of anorexia/cachexia therapy (FAACT) anorexia/cachexia subscale (A/CS) in lung cancer patients with involuntary weight loss.
- Authors
Gelhorn, Heather L.; Gries, Katharine S.; Speck, Rebecca M.; Duus, Elizabeth M.; Bourne, Richard K.; Aggarwal, Dimple; Cella, David
- Abstract
<bold>Purpose: </bold>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.<bold>Methods: </bold>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]).<bold>Results: </bold>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.<bold>Conclusions: </bold>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.
- Subjects
WEIGHT loss; FUNCTIONAL assessment; LUNG cancer; NON-small-cell lung carcinoma; CONFIRMATORY factor analysis
- Publication
Quality of Life Research, 2019, Vol 28, Issue 6, p1641
- ISSN
0962-9343
- Publication type
journal article
- DOI
10.1007/s11136-019-02135-7