Abstract
Health-related quality of life (QOL) assessment is a key component in patient assessment and the development of therapies for malignant pleural mesothelioma. However, no mesothelioma-specific instrument was available. The Lung Cancer Symptom Scale (LCSS), a site-specific instrument used to assess QOL in patients with lung cancer, was identified as an instrument that could be appropriate. A modified nine-item patient-reported and six-item observer-reported LCSS was incorporated into two clinical trials of pemetrexed in patients with pleural mesothelioma. Basic psychometric properties of feasibility, reliability, and validity were tested. Properties were stable or enhanced by deletion of the hemoptysis item. Feasibility was demonstrated with a high completion rate of 90% by 512 patients. Reliability was acceptable, with good internal consistency for the eight-item measure (alpha coefficient=0.86) and reasonably good for the five-item observer measure (alpha coefficient=0.66); there was also good stability for the patient measure using test–retest (r=0.87). Content validity was supported by a literature review and patient self-report of presenting symptoms (>90% of patients had three or more symptoms). Construct validity was well supported by finding better scores in the higher performance status groups and greater symptom improvement in patients with tumor response, good concordance with the LCSS conceptual model and good explanation of variance for summation items, and a high degree of convergence between the patient and observer forms (r=0.57). Criterion-related validity was supported by predicting survival time, time to progression, and tumor response rate; all three summary items and the total LCSS-Meso score were statistically significant predictors (p<0.005). The LCSS-Meso is a feasible, reliable, and valid instrument to assess health-related QOL in patients with pleural mesothelioma. One item, hemoptysis, was dropped from the original LCSS based on these findings.
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References
Sterman DH, Kaiser LR, Albelda SM (1999) Advances in the treatment of malignant pleural mesothelioma. Chest 116:504–520
Ruffie P, Feld R, Minkin S et al (1989) Diffuse malignant mesothelioma of the pleura in Ontario and Quebec: a retrospective study of 332 patients. J Clin Oncol 7:1157–1168
Favaretto AG, Aversa SM, Paccagnella A et al (2003) Gemcitabine combined with carboplatin in patients with malignant pleural mesothelioma: a multicentric phase II study. Cancer 97:2791–2797
Fizazi K, Doubre H, Le Chevalier T et al (2003) Combination of raltitrexed and oxaliplatin is an active regimen in malignant mesothelioma: results of a phase II study. J Clin Oncol 21:349–354
Antman KH, Schiff PB, Pass HI (1997) Benign and malignant mesothelioma. In: DeVita VT, Hellman S, Rosenberg SA (eds) Cancer: principles and practice of oncology, 5th edn. Lippincott-Raven, Philadelphia, pp 1853–1878
Sugarbaker DJ, Norberto JJ, Bueno R (1997) Current therapy for mesothelioma. Cancer Control 4:326–334
Aisner J (1995) Current approach to malignant mesothelioma of the pleura. Chest 107:332S–344S
Alberts AS, Falkson G, Goedhals L, Vorobiof DA, Van der Merwe CA (1988) Malignant pleural mesothelioma: a disease unaffected by current therapeutic maneuvers. J Clin Oncol 6:527–535
Chahinian AP, Pajak TF, Holland JF, Norton L, Ambinder RM, Mandel EM (1982) Diffuse malignant mesothelioma: prospective evaluation of 69 patients. Ann Int Med 96:746–755
Steele JP, Shamash J, Evans MT, Gower NH, Tischkowitz MD, Rudd RM (2000) Phase II study of vinorelbine in patients with malignant pleural mesothelioma. J Clin Oncol 18:3912–3917
Skubitz KM (2002) Phase II trial of pegylated-liposomal doxorubicin (Doxil) in mesothelioma. Cancer Investig 20:693–699
van Meerbeeck JP, Baas P, Debruyne C et al (2002) A phase II EORTC study of temozolomide in patients with malignant pleural mesothelioma. Eur J Cancer 38:779–783
Peto J, Hodgson JT, Matthew FE, Jones JR (1995) Continuing increase in mesothelioma mortality in Britain. Lancet 345:535–539
Ryan CW, Herndon J, Vogelzang NJ (1998) A review of chemotherapy trials for malignant mesothelioma. Chest 113:66S–73S
Vogelzang NJ, Rusthoven JJ, Symanowski J et al (2003) Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol 21:2636–2644
Ong ST, Vogelzang NJ (1996) Chemotherapy in malignant pleural mesothelioma: a review. J Clin Oncol 14:1007–1017
Fizazi K, John WJ, Vogelzang NJ (2002) The emerging role of antifolates in the treatment of malignant pleural mesothelioma. Semin Oncol 29:77–81
Kindler HL, Millard F, Herndon JE II, Vogelzang NJ, Suzuki Y, Green MR (2001) Gemcitabine for malignant mesothelioma: a phase II trial by the Cancer and Leukemia Group B. Lung Cancer 31:311–317
Williams G, Pazdur R, Temple R (2004) Assessing tumor-related signs and symptoms to support cancer drug approval. J Biopharm Stat 14(1):5–21
Outcomes Working Group, Health Services Research Committee, American Society of Clinical Oncology (1996) Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. J Clin Oncol 14:671–679
Sloan JA, Cella D, Frost M, Guyatt GH, Sprangers M, Symonds T, Clinical Significance Consensus Meeting Group (2002) Assessing clinical significance in measuring oncology patient quality of life: introduction to the symposium, content overview, and definition of terms. Mayo Clin Proc 77:367–370
Hollen PJ, Gralla RJ, Kris MG (1995) An overview of the Lung Cancer Symptom Scale. In: Gralla RJ, Moinpour CM (eds) Assessing quality of life in patients with lung cancer: a guide for clinicians. NCM Publishers, New York, pp 57–63
Scagliotti GV, Shin DM, Kindler HL et al (2003) Phase II study of pemetrexed with and without folic acid and vitamin B12 as front-line therapy in malignant pleural mesothelioma. J Clin Oncol 21:1556–1561
Brislin RW (1970) Back-translation for cross-cultural research. J Cross-Cult Psychol 1:185–216
Chapman DW, Carter JF (1979) Translation procedures for the cross cultural use of measurement instruments. Educ Eval Policy Anal 1:71–76
Nunnally JC, Berstein IH (1994) Psychometric theory, 3rd edn. McGraw-Hill, New York
Hulley SB, Cummings SR, Browner WS, Grady D, Hearst N, Newman TB (2001) Designing clinical research, 2nd edn. Lippincott, Williams, & Wilkins, Philadelphia
Knapp TR (1985) Validity, reliability, and neither. Nurs Res 34:189–192
Waltz CF, Strickland OL, Lenz ER (1991) In: Measurement in nursing research, 2nd edn. FA Davis, Philadelphia
Anastasi A (1988) Psychological testing, 6th edn. Macmillan, New York
Frank-Stromborg M, Olsen SJ (2004) Instruments for clinical health-care research, 3rd edn. Jones and Bartlett, Boston
Gralla R, Hollen P, Liepa A et al (2003) Documenting symptom palliation with chemotherapy using the LCSS-Meso: results from the randomized trial of pemetrexed plus cisplatin vs cisplatin alone in patients with malignant pleural mesothelioma. Eur J Cancer Suppl 1:S272
Hollen PJ, Gralla RJ, Liepa AM, Symanowski JT, Rusthoven JJ (2004) Adapting the Lung Cancer Symptom Scale (LCSS) to mesothelioma: using the LCSS-Meso conceptual model for validation. Cancer 101:587–595
Gralla RJ, Symanowski JT, Liepa AM et al (2003) Can baseline quality of life parameters predict survival and other efficacy outcomes in malignant pleural mesothelioma?: results from a 448-patient phase III trial. Lung Cancer 41:S220
Schroeder MA (1990) Diagnosing and dealing with multicollinearity. West J Nurs Res 12:175–187
Hollen PJ, Gralla RJ, Kris MG, Potanovich LM (1993) Quality of life assessment in individuals with lung cancer: testing the Lung Cancer Symptom Scale (LCSS). Eur J Cancer 29A:S51–S58
Hollen PJ, Gralla RJ, Kris MG, Cox C (1994) Quality of life during clinical trials: conceptual model for the Lung Cancer Symptom Scale (LCSS). Support Care Cancer 2:213–222
Hollen PJ, Gralla RJ, Kris MG et al (1994) Measurement of quality of life in patients with lung cancer in multicenter trials of new therapies: psychometric assessment of the Lung Cancer Symptom Scale. Cancer 73:2087–2098
Hollen PJ, Gralla RJ, Kris MG, Eberly SW, Cox C (1999) Normative data and trends in quality of life from the Lung Cancer Symptom Scale (LCSS). Support Care Cancer 7:140–148
Karnofsky DA, Burchenal JH (1949) The clinical evaluation of chemotherapeutic agents in cancer. In: MacLeod CM (ed) Evaluation of chemotherapeutic agents. Symposium, Microbiology Section, New York Academy of Medicine. Columbia University Press, New York, pp 191–205
Simon R, Wittes RE (1985) Methodologic guidelines for reports of clinical trials. Cancer Treat Rep 69:1–3
Hollen PJ, Gralla RJ, Symanowski JT, Liepa AM, Bizette GA (2004) Determining the frequency of quality of life assessment in chemotherapy treatment: using the LCSS-Meso in the randomized pemetrexed + cisplatin trial in 448 patients with mesothelioma as an example. J Clin Oncol 22:760S
Hollen PJ, Gralla RJ, Rittenberg CN (2004) Quality of life as a clinical trial endpoint: determining the appropriate interval for repeated assessments in patients with advanced lung cancer. Support Care Cancer 12:767–773
Nowak AK, Stockler MR, Byrne MJ (2004) Assessing quality of life during chemotherapy for pleural mesothelioma: feasibility, validity, and results of using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire and Lung Cancer Module. J Clin Oncol 22:3172–3180
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This work was supported by a grant from Eli Lilly and Company (Indianapolis, IN).
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Hollen, P.J., Gralla, R.J., Liepa, A.M. et al. Measuring quality of life in patients with pleural mesothelioma using a modified version of the Lung Cancer Symptom Scale (LCSS): psychometric properties of the LCSS-Meso. Support Care Cancer 14, 11–21 (2006). https://doi.org/10.1007/s00520-005-0837-0
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DOI: https://doi.org/10.1007/s00520-005-0837-0