Top

Gepubliceerd in:

22-02-2019

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

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

Gepubliceerd in: Quality of Life Research | Uitgave 6/2019

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.

vorige artikel Supporting construct validity of the Evaluation of Daily Activity Questionnaire using Linear Logistic Test Models

volgende artikel Development and validation of the caregiver roles and responsibilities scale in cancer caregivers

Alleen toegankelijk voor geautoriseerde gebruikers

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.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

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.CrossRefPubMed

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.CrossRefPubMedPubMedCentral

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

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

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

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.CrossRef

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.CrossRefPubMed

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.CrossRefPubMed

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.CrossRefPubMedPubMedCentral

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.CrossRefPubMed

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.CrossRefPubMed

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.CrossRefPubMedPubMedCentral

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.CrossRefPubMed

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.CrossRefPubMed

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.CrossRefPubMed

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.

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.

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.CrossRefPubMed

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.CrossRefPubMed

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.CrossRefPubMedPubMedCentral

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.CrossRefPubMed

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.

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.CrossRefPubMed

26.

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

27.

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

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.CrossRefPubMed

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.

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.CrossRefPubMed

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.CrossRef

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.CrossRefPubMed

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.

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.CrossRefPubMed

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
Auteurs: Heather L. Gelhorn
Katharine S. Gries
Rebecca M. Speck
Elizabeth M. Duus
Richard K. Bourne
Dimple Aggarwal
David Cella
Publicatiedatum: 22-02-2019
Uitgeverij: Springer International Publishing
Gepubliceerd in: Quality of Life Research / Uitgave 6/2019
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI: https://doi.org/10.1007/s11136-019-02135-7

Bohn Stafleu van Loghum

Deel dit onderdeel of sectie (kopieer de link)

Abstract

Purpose

Methods

Results

Conclusions

Log in om toegang te krijgen

Andere artikelen Uitgave 6/2019

Health-related quality of life among children, adolescents, and adults with bladder exstrophy–epispadias complex: a systematic review of the literature and recommendations for future research

Leveraging Latent Dirichlet Allocation in processing free-text personal goals among patients undergoing bladder cancer surgery

A pilot study on aesthetic treatments performed by qualified aesthetic practitioners: efficacy on health-related quality of life in breast cancer patients

Association of nutritional status and health-related quality of life in children with chronic kidney disease

Psychometric properties of the Mandarin Chinese version of the KIDSCREEN-52 health-related quality of life questionnaire in adolescents: a cross-sectional study

Development and validation of the caregiver roles and responsibilities scale in cancer caregivers