International validation of the EORTC QLQ-CLL17 questionnaire for assessment of health-related quality of life for patients with chronic lymphocytic leukaemia.
EORTC
PRO
chronic lymphocytic leukaemia
psychometric properties
quality of life
questionnaire
symptoms
Journal
British journal of haematology
ISSN: 1365-2141
Titre abrégé: Br J Haematol
Pays: England
ID NLM: 0372544
Informations de publication
Date de publication:
05 2022
05 2022
Historique:
revised:
18
01
2022
received:
16
11
2021
accepted:
21
01
2022
pubmed:
8
3
2022
medline:
11
5
2022
entrez:
7
3
2022
Statut:
ppublish
Résumé
Selecting the most appropriate chronic lymphocytic leukaemia (CLL) treatment is challenging. Patient-reported health-related quality of life (HRQoL) is therefore a critical aspect to consider. This international study by the European Organization for Research and Treatment of Cancer (EORTC) tested the psychometric properties of a newly developed measure for CLL patients: the EORTC QLQ-CLL17 to supplement the core questionnaire (EORTC QLQ-C30). Patients with CLL (n = 341) from 12 countries completed the QLQ-C30, QLQ-CLL17 and a debriefing questionnaire. Sociodemographic and clinical data were recorded from medical records. A high percentage (30%-66%) reported symptoms and/or worries (e.g. aches/pains in muscles, lack of energy and worry/fears about health). Confirmatory factor analysis showed an acceptable to good fit of the 17 items on the three scales (i.e. symptom burden, physical condition/fatigue and worries/fears about health and functioning). Completion took on average 8 min. Test-retest and convergent validity was demonstrated. The QLQ-CLL17 differentiated between patients with an Eastern Cooperative Oncology group (ECOG) performance of 0 versus 1-3 (p's < 0.01 and clinically relevant). The newly developed EORTC QLQ-CLL17 will increase sensitivity of HRQoL assessment in patients with CLL. Implementation of this questionnaire both in clinical research and practice will help to generate unique clinically relevant data to better inform CLL treatment decision-making.
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
431-441Informations de copyright
© 2022 British Society for Haematology and John Wiley & Sons Ltd.
Références
Nabhan C, Rosen ST. Chronic lymphocytic leukemia: a clinical review. JAMA. 2014;312(21):2265-76.
van den Broek EC, Kater AP, van de Schans SA, Karim-Kos HE, Janssen-Heijnen ML, Peters WG, et al. Chronic lymphocytic leukaemia in the Netherlands: trends in incidence, treatment and survival, 1989-2008. Eur J Cancer. 2012;48(6):889-95.
Weide R, Feiten S, Chakupurakal G, Friesenhahn V, Kleboth K, Koppler H, et al. Survival improvement of patients with chronic lymphocytic leukemia (CLL) in routine care 1995-2017. Leuk Lymphoma. 2020;61(3):557-66.
Eichhorst B, Robak T, Montserrat E, Ghia P, Niemann CU, Kater AP, et al. Chronic lymphocytic leukaemia: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2021;32(1):23-33.
Michallet AS, Aktan M, Hiddemann W, Ilhan O, Johansson P, Laribi K, et al. Rituximab plus bendamustine or chlorambucil for chronic lymphocytic leukemia: Primary analysis of the randomized, open-label MABLE study. Haematologica. 2018;103(4):698-706.
Moreno C, Greil R, Demirkan F, Tedeschi A, Anz B, Larratt L, et al. Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab in first-line treatment of chronic lymphocytic leukaemia (iLLUMINATE): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019;20(1):43-56.
Shanafelt TD, Wang XV, Kay NE, Hanson CA, O'Brien S, Barrientos J, et al. Ibrutinib-rituximab or chemoimmunotherapy for chronic lymphocytic leukemia. N Engl J Med. 2019;381(5):432-43.
Woyach JA, Ruppert AS, Heerema NA, Zhao W, Booth AM, Ding W, et al. Ibrutinib regimens versus chemoimmunotherapy in older patients with untreated CLL. N Engl J Med. 2018;379(26):2517-28.
Gaidano G, Rossi D. The mutational landscape of chronic lymphocytic leukemia and its impact on prognosis and treatment. Hematology Am Soc Hematol Educ Program. 2017;2017(1):329-37.
Rhodes JM, Barrientos JC. Chemotherapy-free frontline therapy for CLL: is it worth it? Hematology Am Soc Hematol Educ Program. 2020;2020(1):24-32.
Eichhorst BF, Busch R, Obwandner T, Kuhn-Hallek I, Herschbach P, Hallek M. Health-related quality of life in younger patients with chronic lymphocytic leukemia treated with fludarabine plus cyclophosphamide or fludarabine alone for first-line therapy: a study by the German CLL study group. J Clin Oncol. 2007;25(13):1722-31.
Else M, Cocks K, Crofts S, Wade R, Richards SM, Catovsky D, et al. Quality of life in chronic lymphocytic leukemia: 5-year results from the multicenter randomized LRF CLL4 trial. Leuk Lymphoma. 2012;53(7):1289-98.
Hillmen P, Janssens A, Babu KG, Kloczko J, Grosicki S, Manson S, et al. Health-related quality of life and patient-reported outcomes of ofatumumab plus chlorambucil versus chlorambucil monotherapy in the COMPLEMENT 1 trial of patients with previously untreated CLL. Acta Oncol. 2016;55(9-10):1115-20.
Holtzer-Goor KM, Schaafsma MR, Joosten P, Posthuma EF, Wittebol S, Huijgens PC, et al. Quality of life of patients with chronic lymphocytic leukaemia in the Netherlands: results of a longitudinal multicentre study. Qual Life Res. 2015;24(12):2895-906.
Kutsch N, Bahlo J, Robrecht S, Franklin J, Zhang C, Maurer C, et al. Long term follow-up data and health-related quality of life in frontline therapy of fit patients treated with FCR versus BR (CLL10 trial of the GCLLSG). Hemasphere. 2020;4(1):e336.
van den Broek EC, Oerlemans S, Nijziel MR, Posthuma EF, Coebergh JW, van de Poll-Franse LV. Impact of active surveillance, chlorambucil, and other therapy on health-related quality of life in patients with CLL/SLL in the Netherlands. Ann Hematol. 2015;94(1):45-56.
Holzner B, Kemmler G, Kopp M, Nguyen-Van-Tam D, Sperner-Unterweger B, Greil R. Quality of life of patients with chronic lymphocytic leukemia: results of a longitudinal investigation over 1 yr. Eur J Haematol. 2004;72(6):381-9.
Kutsch N, Busch R, Bahlo J, Mayer J, Hensel M, Hopfinger G, et al. FCR front-line therapy and quality of life in patients with chronic lymphocytic leukemia. Leuk Lymphoma. 2017;58(2):399-407.
Efficace F, Iurlo A, Patriarca A, Stagno F, Bee PC, Ector G, et al. Validation and reference values of the EORTC QLQ-CML24 questionnaire to assess health-related quality of life in patients with chronic myeloid leukemia. Leuk Lymphoma. 2021;62(3):669-78.
Efficace F, Kemmler G, Vignetti M, Mandelli F, Molica S, Holzner B. Health-related quality of life assessment and reported outcomes in leukaemia randomised controlled trials-a systematic review to evaluate the added value in supporting clinical decision making. Eur J Cancer. 2008;44(11):1497-506.
Thanarajasingam G, Minasian LM, Baron F, Cavalli F, De Claro RA, Dueck AC, et al. Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies. Lancet Haematol. 2018;5(11):e563-e98.
Barrientos JC, O'Brien S, Brown JR, Kay NE, Reddy NM, Coutre S, et al. Improvement in parameters of hematologic and immunologic function and patient well-being in the phase III RESONATE study of ibrutinib versus ofatumumab in patients with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma. Clin Lymphoma Myeloma Leuk. 2018;18(12):803-13 e7.
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365-76.
Cramer P, Fraser G, Santucci-Silva R, Grosicki S, Dilhuydy MS, Janssens A, et al. Improvement of fatigue, physical functioning, and well-being among patients with severe impairment at baseline receiving ibrutinib in combination with bendamustine and rituximab for relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma in the HELIOS study. Leuk Lymphoma. 2018;59(9):2075-84.
van de Poll-Franse L, Oerlemans S, Bredart A, Kyriakou C, Sztankay M, Pallua S, et al. International development of four EORTC disease-specific quality of life questionnaires for patients with Hodgkin lymphoma, high- and low-grade non-Hodgkin lymphoma and chronic lymphocytic leukaemia. Qual Life Res. 2018;27(2):333-45.
Johnson, CD, Aaronson, NK, Blazeby, J, Bottomley, A, Fayers, P & Koeller, M et al. Guidelines for developing questionnaire modules.4th ed;2011. Available from: https://www.eortc.org/app/uploads/sites/2/2018/02/guidelines_for_developing_questionnaire-_final.pdf
Swerdlow SH, Campo E, Harris NL, Jaffe ES, Pileri SA, Stein H, et al. In: Bosman FT, Jaffe ES, Lakhani SR, Ohgaki H, editors. WHO classification of tumours of haematopoietic and lymfoid tissues. Lyon: IARC; 2008.
Kulis D, Bottomley A, Velikova G, Greimel E, Koller M on behalf of the EORTC Quality of Life Group. EORTC Quality of Life Group translation procedure.4th ed; 2017. Available at: https://www.eortc.org/app/uploads/sites/2/2018/02/translation_manual_2017.pdf.
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83.
Deyo RA, Cherkin DC, Ciol MA. Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J Clin Epidemiol. 1992;45(6):613-9.
Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-55.
R Core Team. R: A language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing; 2013 Available from: http://www.R-project.org/
Cohen J. Statistical power analysis for the behavioural sciences. New York: Academic Press; 1977.
Rosseel Y. lavaan: an R package for structural equation modeling. J Stat Softw. 2012;48(2):1-36. Available at: http://www.jstatsoft.org/v48/i02/
Jorgensen T.D. Pornprasertmanit S, Schoemann AM., & Rosseel Y. semTools: useful tools for structural equation modeling. R package version 0.5-4; 2021. Available at: https://CRAN.R-project.org/package=semTools
Schermelleh-Engel KMH, Müller H. Evaluating the fit of structural equation models: tests of significance and descriptive goodness-of-fit measures. MPR-Online. 2003;8:23-74.
Ferguson E, Cox T. Exploratory factor analysis: a users' guide. Int J Sel Assess. 1993;1:84-94.
Cronbach L. Coefficient alpha and the internal structure of test. Psychom Theory. 1951;16:297-334.
de Vet HCW, Terwee CB, Mokkink LB, Knol DL. Measurement in medicine: a practical guide. Cambridge, New York: Cambridge University Press; 2011.
McGraw KO, Wong SP. Forming inferences about some intraclass correlation coefficients. Psychol Methods. 1996;1(1):30-46.
Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007;60(1):34-42.
Fayers P, Machin D. Quality of life: the assessment, analysis and interpretation of patient-reported outcomes. Chichester, UK: John Wiley & Sons; 2007.
Arts LPJ, Oerlemans S, Tick L, Koster A, Roerdink HTJ, van de Poll-Franse LV. More frequent use of health care services among distressed compared with nondistressed survivors of lymphoma and chronic lymphocytic leukemia: results from the population-based PROFILES registry. Cancer. 2018;124(14):3016-24.
Sharpe L, Thewes B, Butow P. Current directions in research and treatment of fear of cancer recurrence. Curr Opin Support Palliat Care. 2017;11(3):191-6.
Butow P, Sharpe L, Thewes B, Turner J, Gilchrist J, Beith J. Fear of cancer recurrence: a practical guide for clinicians. Oncology (Williston Park). 2018;32(1):32-8.
Luckett T, King MT, Butow PN, Oguchi M, Rankin N, Price MA, et al. Choosing between the EORTC QLQ-C30 and FACT-G for measuring health-related quality of life in cancer clinical research: Issues, evidence and recommendations. Ann Oncol. 2011;22(10):2179-90.
Osoba D, Zee B, Pater J, Warr D, Kaizer L, Latreille J. Psychometric properties and responsiveness of the EORTC quality of life questionnaire (QLQ-C30) in patients with breast, ovarian and lung cancer. Qual Life Res. 1994;3(5):353-64.
Evans J, Ziebland S, Pettitt AR. Incurable, invisible and inconclusive: watchful waiting for chronic lymphocytic leukaemia and implications for doctor-patient communication. Eur J Cancer Care (Engl). 2012;21(1):67-77.
Williams A, Yarosh R, Clark J, Casulo C, Barr PM, Kamen CS, et al. Correlates of anxiety and depression in chronic lymphocytic leukemia (CLL) survivors. J Clin Oncol. 2018;36(7_suppl):153.
Kulis D, Bottomley A, Whittaker C, van de Poll-Franse LV, Darlington A, Holzner B, et al. The use of the Eortc item library to supplement Eortc quality of life instruments. Value Health. 2017;20(9):A775.