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Erschienen in: Quality of Life Research 6/2019

22.02.2019 | NSCLC

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

verfasst von: Heather L. Gelhorn, Katharine S. Gries, Rebecca M. Speck, Elizabeth M. Duus, Richard K. Bourne, Dimple Aggarwal, David Cella

Erschienen in: Quality of Life Research | Ausgabe 6/2019

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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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Literatur
2.
Zurück zum Zitat 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.CrossRefPubMed 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.CrossRefPubMed
3.
5.
Zurück zum Zitat 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.CrossRefPubMed 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.CrossRefPubMed
6.
Zurück zum Zitat 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.CrossRef 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.CrossRef
7.
Zurück zum Zitat 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.CrossRefPubMed 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.CrossRefPubMed
12.
Zurück zum Zitat 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.CrossRefPubMed 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.CrossRefPubMed
15.
Zurück zum Zitat 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.CrossRefPubMed 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.CrossRefPubMed
18.
Zurück zum Zitat 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. 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.
19.
Zurück zum Zitat 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. 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.
20.
Zurück zum Zitat 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.CrossRefPubMed 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.CrossRefPubMed
21.
Zurück zum Zitat 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.CrossRefPubMed 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.CrossRefPubMed
23.
Zurück zum Zitat 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.CrossRefPubMed 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.CrossRefPubMed
24.
Zurück zum Zitat 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. 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.
25.
Zurück zum Zitat 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.CrossRefPubMed 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.CrossRefPubMed
26.
Zurück zum Zitat Urquhart, C. (2013). Grounded theory for qualitative research: A practical guide. Thousand Oaks: Sage.CrossRef Urquhart, C. (2013). Grounded theory for qualitative research: A practical guide. Thousand Oaks: Sage.CrossRef
27.
Zurück zum Zitat Given, L. M. (2016). 100 questions (and answers) about qualitative research. Thousand Oaks: Sage. Given, L. M. (2016). 100 questions (and answers) about qualitative research. Thousand Oaks: Sage.
29.
Zurück zum Zitat Muthén, L. K., & Muthén, B. O. (1998–2017). Mplus user’s guide (8th edn.). Los Angeles: Muthén & Muthén. Muthén, L. K., & Muthén, B. O. (1998–2017). Mplus user’s guide (8th edn.). Los Angeles: Muthén & Muthén.
30.
Zurück zum Zitat Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd edn.). Hillsdale: Lawrence Erlbaum Associates. Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd edn.). Hillsdale: Lawrence Erlbaum Associates.
31.
Zurück zum Zitat 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.CrossRefPubMed 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.CrossRefPubMed
34.
Zurück zum Zitat 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. 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.
Metadaten
Titel
Comprehensive validation of the functional assessment of anorexia/cachexia therapy (FAACT) anorexia/cachexia subscale (A/CS) in lung cancer patients with involuntary weight loss
verfasst von
Heather L. Gelhorn
Katharine S. Gries
Rebecca M. Speck
Elizabeth M. Duus
Richard K. Bourne
Dimple Aggarwal
David Cella
Publikationsdatum
22.02.2019
Verlag
Springer International Publishing
Erschienen in
Quality of Life Research / Ausgabe 6/2019
Print ISSN: 0962-9343
Elektronische ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-019-02135-7

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