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

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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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References

  1. Fearon, K., Strasser, F., Anker, S. D., Bosaeus, I., Bruera, E., Fainsinger, R. L., et al. (2011). Definition and classification of cancer cachexia: an international consensus. Lancet Oncology, 12(5), 489–495. https://doi.org/10.1016/S1470-2045(10)70218-7.

    Article  PubMed  Google Scholar 

  2. Vigano, A., Bruera, E., Jhangri, G. S., Newman, S. C., Fields, A. L., & Suarez-Almazor, M. E. (2000). Clinical survival predictors in patients with advanced cancer. Archives of Internal Medicine, 160(6), 861–868.

    Article  CAS  PubMed  Google Scholar 

  3. Bamia, C., Halkjaer, J., Lagiou, P., Trichopoulos, D., Tjonneland, A., Berentzen, T. L., et al. (2010). Weight change in later life and risk of death amongst the elderly: The European Prospective Investigation into Cancer and Nutrition-Elderly Network on Ageing and Health study. Journal of Internal Medicine, 268(2), 133–144. https://doi.org/10.1111/j.1365-2796.2010.02219.x.

    Article  CAS  PubMed  Google Scholar 

  4. Ross, P. J., Ashley, S., Norton, A., Priest, K., Waters, J. S., Eisen, T., et al. (2004). Do patients with weight loss have a worse outcome when undergoing chemotherapy for lung cancers? British Journal of Cancer, 90(10), 1905–1911. https://doi.org/10.1038/sj.bjc.6601781.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  5. Baldwin, C., Spiro, A., McGough, C., Norman, A. R., Gillbanks, A., Thomas, K., et al. (2011). Simple nutritional intervention in patients with advanced cancers of the gastrointestinal tract, non-small cell lung cancers or mesothelioma and weight loss receiving chemotherapy: A randomised controlled trial. Journal of Human Nutrition and Dietetics, 24(5), 431–440. https://doi.org/10.1111/j.1365-277X.2011.01189.x.

    Article  CAS  PubMed  Google Scholar 

  6. von Haehling, S., Anker, M. S., & Anker, S. D. (2016). Prevalence and clinical impact of cachexia in chronic illness in Europe, USA, and Japan: Facts and numbers update 2016. The Journal of Cachexia, Sarcopenia and Muscle, 7(5), 507–509. https://doi.org/10.1002/jcsm.12167.

    Article  Google Scholar 

  7. Dewys, W. D., Begg, C., Lavin, P. T., Band, P. R., Bennett, J. M., Bertino, J. R., et al. (1980). Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. The American Journal of Medicine, 69(4), 491–497.

    Article  CAS  PubMed  Google Scholar 

  8. Del Ferraro, C., Grant, M., Koczywas, M., & Dorr-Uyemura, L. A. (2012). Management of anorexia-cachexia in late stage lung cancer patients. The Journal of Hospice & Palliative Nursing. https://doi.org/10.1097/NJH.0b013e31825f3470.

    Article  Google Scholar 

  9. Molfino, A., Muscaritoli, M., & Rossi Fanelli, F. (2015). Anorexia assessment in patients with cancer: A crucial issue to improve the outcome. Journal of Clinical Oncology, 33(13), 1513. https://doi.org/10.1200/JCO.2014.59.9548.

    Article  PubMed  Google Scholar 

  10. Yavuzsen, T., Davis, M. P., Walsh, D., LeGrand, S., & Lagman, R. (2005). Systematic review of the treatment of cancer-associated anorexia and weight loss. Journal of Clinical Oncology, 23(33), 8500–8511. https://doi.org/10.1200/JCO.2005.01.8010.

    Article  CAS  PubMed  Google Scholar 

  11. Montazeri, A. (2009). Quality of life data as prognostic indicators of survival in cancer patients: An overview of the literature from 1982 to 2008. Health and Quality of Life Outcomes, 7, 102. https://doi.org/10.1186/1477-7525-7-102.

    Article  PubMed  PubMed Central  Google Scholar 

  12. Sundstrom, S., Bremnes, R. M., Brunsvig, P., Aasebo, U., Kaasa, S., & Norwegian Lung Cancer Study (2006). Palliative thoracic radiotherapy in locally advanced non-small cell lung cancer: Can quality-of-life assessments help in selection of patients for short- or long-course radiotherapy? Journal of Thoracic Oncology, 1(8), 816–824. G.

    Article  PubMed  Google Scholar 

  13. Fielding, R., & Wong, W. S. (2007). Quality of life as a predictor of cancer survival among Chinese liver and lung cancer patients. European Journal of Cancer, 43(11), 1723–1730. https://doi.org/10.1016/j.ejca.2007.05.002.

    Article  PubMed  Google Scholar 

  14. McKernan, M., McMillan, D. C., Anderson, J. R., Angerson, W. J., & Stuart, R. C. (2008). The relationship between quality of life (EORTC QLQ-C30) and survival in patients with gastro-oesophageal cancer. British Journal of Cancer, 98(5), 888–893. https://doi.org/10.1038/sj.bjc.6604248.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  15. Collette, L., van Andel, G., Bottomley, A., Oosterhof, G. O., Albrecht, W., de Reijke, T. M., et al. (2004). Is baseline quality of life useful for predicting survival with hormone-refractory prostate cancer? A pooled analysis of three studies of the European Organisation for Research and Treatment of Cancer Genitourinary Group. Journal of Clinical Oncology, 22(19), 3877–3885. https://doi.org/10.1200/JCO.2004.07.089.

    Article  PubMed  Google Scholar 

  16. Yeo, W., Mo, F. K., Koh, J., Chan, A. T., Leung, T., Hui, P., et al. (2006). Quality of life is predictive of survival in patients with unresectable hepatocellular carcinoma. Annals of Oncology, 17(7), 1083–1089. https://doi.org/10.1093/annonc/mdl065.

    Article  CAS  PubMed  Google Scholar 

  17. Sullivan, P. W., Nelson, J. B., Mulani, P. M., & Sleep, D. (2006). Quality of life as a potential predictor for morbidity and mortality in patients with metastatic hormone-refractory prostate cancer. Quality of Life Research, 15(8), 1297–1306. https://doi.org/10.1007/s11136-006-0003-2.

    Article  PubMed  Google Scholar 

  18. Rodriguez, A. M., Braverman, J., Aggarwal, D., Friend, J., & Duus, E. (2017). The experience of weight loss and its associated burden in patients with non-small cell lung cancer: results of an online survey. Journal of Cachexia, Sarcopenia and Muscle-Clinical Reports, 2(2), 1–12.

    Google Scholar 

  19. Cella, D. F., Bonomi, A. E., Leslie, W. T., Von Roenn, J., & Tchekmedyian, N. S. (1993). Quality of life and nutritional well-being: measurement and relationship. Oncology, 7(11), 105–111.

    Google Scholar 

  20. Ribaudo, J. M., Cella, D., Hahn, E. A., Lloyd, S. R., Tchekmedyian, N. S., Von Roenn, J., et al. (2000). Re-validation and shortening of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire. Quality of Life Research, 9(10), 1137–1146.

    Article  CAS  PubMed  Google Scholar 

  21. Cella, D. F., Tulsky, D. S., Gray, G., Sarafian, B., Linn, E., Bonomi, A., et al. (1993). The Functional Assessment of Cancer Therapy scale: Development and validation of the general measure. Journal of Clinical Oncology, 11(3), 570–579.

    Article  CAS  PubMed  Google Scholar 

  22. Webster, K., Cella, D., & Yost, K. (2003). The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System: Properties, applications, and interpretation. Health and Quality of Life Outcomes, 1, 79. https://doi.org/10.1186/1477-7525-1-79.

    Article  PubMed  PubMed Central  Google Scholar 

  23. LeBlanc, T. W., Samsa, G. P., Wolf, S. P., Locke, S. C., Cella, D. F., & Abernethy, A. P. (2015). Validation and real-world assessment of the Functional Assessment of Anorexia-Cachexia Therapy (FAACT) scale in patients with advanced non-small cell lung cancer and the cancer anorexia-cachexia syndrome (CACS). Support Care Cancer, 23(8), 2341–2347. https://doi.org/10.1007/s00520-015-2606-z.

    Article  PubMed  Google Scholar 

  24. Food and Drug Administration. (2009). Guidance for industry on patient-reported outcome measures: Use in medical product development to support labeling claims. Federal Register, 74(235), 65132–65133.

    Google Scholar 

  25. Rothman, M., Burke, L., Erickson, P., Leidy, N. K., Patrick, D. L., & Petrie, C. D. (2009). Use of existing patient-reported outcome (PRO) instruments and their modification: The ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report. Value Health, 12(8), 1075–1083. https://doi.org/10.1111/j.1524-4733.2009.00603.x.

    Article  PubMed  Google Scholar 

  26. Urquhart, C. (2013). Grounded theory for qualitative research: A practical guide. Thousand Oaks: Sage.

    Book  Google Scholar 

  27. Given, L. M. (2016). 100 questions (and answers) about qualitative research. Thousand Oaks: Sage.

    Google Scholar 

  28. Temel, J. S., Abernethy, A. P., Currow, D. C., Friend, J., Duus, E. M., Yan, Y., et al. (2016). Anamorelin in patients with non-small-cell lung cancer and cachexia (ROMANA 1 and ROMANA 2): Results from two randomised, double-blind, phase 3 trials. Lancet Oncology, 17(4), 519–531. https://doi.org/10.1016/S1470-2045(15)00558-6.

    Article  CAS  PubMed  Google Scholar 

  29. Muthén, L. K., & Muthén, B. O. (1998–2017). Mplus user’s guide (8th edn.). Los Angeles: Muthén & Muthén.

  30. Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd edn.). Hillsdale: Lawrence Erlbaum Associates.

    Google Scholar 

  31. Leidy, N. K., & Wyrwich, K. W. (2005). Bridging the gap: Using triangulation methodology to estimate minimal clinically important differences (MCIDs). COPD, 2(1), 157–165.

    Article  PubMed  Google Scholar 

  32. Revicki, D. A., Cella, D., Hays, R. D., Sloan, J. A., Lenderking, W. R., & Aaronson, N. K. (2006). Responsiveness and minimal important differences for patient reported outcomes. Health Quality Life Outcomes, 4, 70. https://doi.org/10.1186/1477-7525-4-70.

    Article  Google Scholar 

  33. Revicki, D., Hays, R. D., Cella, D., & Sloan, J. (2008). Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. Journal of Clinical Epidemiology, 61(2), 102–109. https://doi.org/10.1016/j.jclinepi.2007.03.012.

    Article  PubMed  Google Scholar 

  34. Costello, A. B., & Osborne, J. W. (2005). Best practices in exploratory factor analysis: Four recommendations for getting the most from your analysis. Practical Assessment, Research & Evaluation. 10(7), 1–9.

    Google Scholar 

  35. Cella, D., Lai, J. S., & Stone, A. (2011). Self-reported fatigue: One dimension or more? Lessons from the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) questionnaire. Support Care Cancer, 19(9), 1441–1450. https://doi.org/10.1007/s00520-010-0971-1.

    Article  PubMed  Google Scholar 

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Authors and Affiliations

  1. Patient-Centered Research, Evidera, 7101 Wisconsin Avenue, Suite 1400, 20814, Bethesda, MD, USA

    Heather L. Gelhorn, Katharine S. Gries & Rebecca M. Speck

  2. Helsinn Therapeutics (US), Inc, 170 Wood Avenue South, 5th Floor, Iselin, NJ, 08830, USA

    Elizabeth M. Duus, Richard K. Bourne & Dimple Aggarwal

  3. Feinberg School of Medicine, Northwerstern University, 633 N. Saint Clair Street, 19th Floor, Chicago, IL, 60611, USA

    David Cella

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  1. Heather L. Gelhorn
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Correspondence to Heather L. Gelhorn.

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Gelhorn, H.L., Gries, K.S., Speck, R.M. et al. Comprehensive validation of the functional assessment of anorexia/cachexia therapy (FAACT) anorexia/cachexia subscale (A/CS) in lung cancer patients with involuntary weight loss. Qual Life Res 28, 1641–1653 (2019). https://doi.org/10.1007/s11136-019-02135-7

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