Journal of Clinical Epidemiology
Volume 63, Issue 3 , Pages 270-281 , March 2010

Meta-analysis provides evidence-based effect sizes for a cancer-specific quality-of-life questionnaire, the FACT-G

  • Madeleine T. King

      Affiliations

    • Quality of Life Office, Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, Sydney, NSW 2006, Australia
    • Centre for Health Economics Research and Evaluation, University of Technology, Sydney, NSW, Australia
    • Corresponding Author InformationCorresponding author. Quality of Life Office, Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, Brennan MacCallum Building (A18), Sydney, NSW 2006, Australia. Tel.: +61-2-9036-6114; fax: +61-2-9036-5292.
  • ,
  • Martin R. Stockler

      Affiliations

    • Sydney Cancer Centre, Royal Prince Alfred & Concord Hospitals, University of Sydney, NSW, Australia
    • NHMRC Clinical Trials Centre, University of Sydney, NSW, Australia
  • ,
  • David F. Cella

      Affiliations

    • Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA
  • ,
  • David Osoba

      Affiliations

    • QOL Consulting, Vancouver, BC, Canada
  • ,
  • David T. Eton

      Affiliations

    • Mayo Clinic, Department of Health Sciences Research, Rochester, MN, USA
  • ,
  • Joanna Thompson

      Affiliations

    • Centre for Health Economics Research and Evaluation, University of Technology, Sydney, NSW, Australia
  • ,
  • Amy R. Eisenstein

      Affiliations

    • Center for Research on Health and Aging, University of Illinois, Chicago, IL, USA

,Accepted 11 May 2009.

References 

  1. Erickson P. Assessing health status and quality of life of cancer patients: the use of general instruments. In:  Lipscomb J,  Gotay C,  Snyder C editor. Outcomes assessment in cancer. Cambridge: New York; 2005;p. 31–68
  2. Osoba D, King M. Interpreting quality of life in individuals and groups: meaningful differences. In:  Fayers P,  Hays R editor. Assessing quality of life in clinical trials: methods and practice. Oxford University Press; 2005;p. 243–257
  3. Norman G. Hi! How are you? Response shift, implicit theories and differing epistemologies. Qual Life Res. 2003;12(3):239–249
  4. Schwartz CE, Sprangers MA. Adaptation to changing health: response shift in quality-of-life research. 1st edition. Washington: American Psychological Association; 2000;227
  5. Cohen J. Statistical power analysis for the behavioural sciences. 2nd edition. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988;pp. 1–567
  6. Jaeschke R, Singer J, Guyatt GH. Measurement of health status: ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10:407–415
  7. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003;41:582–592
  8. Beaton DE. Simple as possible? Or too simple? Possible limits to the universality of the one half standard deviation. Med Care. 2003;41:593–596
  9. Farivar SS, Liu H, Hays RD. Half standard deviation estimate of the minimally important difference in HRQOL scores?. Expert Rev Pharmacoeconomics Outcomes Res. 2004;4:515–523
  10. Wright JG. Interpreting health-related quality of life scores: the simple rule of seven may not be so simple. Med Care. 2003;41:597–598
  11. Cohen J. Statistical power analysis for the behavioral sciences. 2nd edition. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988;
  12. Lydick E, Epstein RS. Interpretation of quality of life changes. Qual Life Res. 1993;2:221–226
  13. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organisation for Research and Treatment of Cancer (EORTC) modular approach to quality of life assessment in oncology: an update. In:  Spilker B editors. Quality of life and pharmacoeconomics in clinical trials. Philadelphia: Lippincott-Raven Publishers; 1996;p. 179–189
  14. King MT. The interpretation of scores from the EORTC quality of life questionnaire QLQ-C30. Qual Life Res. 1996;5(6):555–567
  15. King MT, Ahmedzai S, Bergman B. Cohen confirmed? Empirical effect sizes for the QLQ-C30. Qual Life Res. 2001;10(3):278
  16. Cella DF, Tulsky DS, Gray G, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993;11:570–579
  17. Ferrell BR, Hassey Dow K, Grant M. Measurement of the quality of life in cancer survivors. Qual Life Res. 1995;4(6):523–531
  18. Cella DF, Bonomi AE, Lloyd SR, et al. Reliability and validity of the Functional Assessment of Cancer Therapy-Lung (FACT-L) quality of life instrument. Lung Cancer. 1995;12(3):199–220
  19. D'Antonio LL, Long SA, Zimmerman GJ, Peterman A, Petti G, Chonkich GD. Relationship between quality of life and depression in patients with head and neck cancer. Laryngoscope. 1998;108:806–811
  20. Dapueto JJ, Francolino C, Gotta I, et al. Evaluation of the Functional Assessment of Cancer Therapy-General Questionnaire (FACT-G) in a South American Spanish speaking population. Psychooncology. 2001;10(1):88–92
  21. Fumimoto H, Kobayashi K, Chang CH, et al. Cross-cultural validation of an international questionnaire, the General Measure of the Functional Assessment of Cancer Therapy scale (FACT-G), for Japanese. Qual Life Res. 2001;10(8):701–709
  22. Cella DF, Dineen KZ, Arnason B, et al. Validation of the functional assessment of multiple sclerosis quality of life instrument. Neurology. 1996;47:129–139
  23. Brady MJ, Cella DF, Mo F, et al. Reliability and validity of the functional assessment of cancer therapy-breast quality-of-life instrument. J Clin Oncol. 1997;15:974–986
  24. McQuellon RP, Russell GB, Cella DF, et al. Quality of life measurement in bone marrow transplantation: development of the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale. Bone Marrow Transplant. 1997;19(4):357–368
  25. Weitzner MA, Meyers CA, Gelke CK, Byrne KS, Cella DF, Levin VA. The Functional Assessment of Cancer Therapy (FACT) scale. Development of a brain subscale and revalidation of the general version (FACT-G) in patients with primary brain tumors. Cancer. 1995;75:1151–1161
  26. Sharp LK, Knight SJ, Nadler R, et al. Quality of life in low-income patients with metastatic prostate cancer: divergent and convergent validity of three instruments. Qual Life Res. 1999;8(5):461–470
  27. Lau AKL, Chang CH, Tai JWM, et al. Translation and validation of the functional assessment of cancer therapy-bone marrow transplant (FACT-BMT) version 4 quality of life instrument into traditional Chinese. Bone Marrow Transplant. 2002;29(1):41–49
  28. Tate DG, Riley BB, Perna R, Roller S. Quality of life issues among women with physical disabilities or breast cancer. Arch Phys Med Rehabil. 1997;78(12 Suppl 5):S18–S25
  29. Follman D, Elliott P, Suh I, Cutler J. Variance imputation for overviews of clinical trials with continuous response. J Clin Epidemiol. 1992;45:769–773
  30. Deeks J, Higgins J, Altman D. Section 8: Analysing and presenting results. In:  Higgins J,  Green S editor. Cochrane handbook for systematic reviews of interventions 4.2.6 [updated September 2006]. The Cochrane Library, Issue 4, 2006. Chichester, UK: John Wiley & Sons, Ltd.; 2006;
  31. Hedges LV, Olkin I. Statistical methods for meta-analysis. Orlando: Academic Press; 1985;
  32. Landis J, Koch G. The measurement of observer agreement for categorical data. Biometrics. 1977;33:159–174
  33. Fallowfield LJ, Leaity SK, Howell A, Benson S, Cella D. Assessment of quality of life in women undergoing hormonal therapy for breast cancer: validation of an endocrine symptom subscale for the FACT-B. Breast Cancer Res Treat. 1999;55(2):189–199
  34. Cella DF, McCain NL, Peterman AH, Mo F, Wolen D. Development and validation of the Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) quality of life instrument. Qual Life Res. 1996;5:450–463
  35. Auchter RM, Scholtens D, Adak S, Wagner H, Cella D, Mehta MM. Quality of life assessment in advanced non-small-cell lung cancer patients undergoing an accelerated radiotherapy regimen: report of ECOG study 4593. Eastern Cooperative Oncology Group. Int J Radiat Oncol Biol Phys. 2001;50:1199–1206
  36. Holzner B, Kemmler G, Kopp M, et al. Quality of life in breast cancer patients—not enough attention for long-term survivors?. Psychosomatics. 2001;42(2):117–123
  37. Krupski T, Petroni GE, Bissonette EA, Theodorescu D. Quality-of-life comparison of radical prostatectomy and interstitial brachytherapy in the treatment of clinically localized prostate cancer. Urology. 2000;55:736–742
  38. Ward WL, Hahn EA, Mo F, Hernandez L, Tulsky DS, Cella D. Reliability and validity of the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) quality of life instrument. Qual Life Res. 1999;8(3):181–195
  39. Tefilli MV, Gheiler EL, Tiguert R, et al. Quality of life in patients undergoing salvage procedures for locally recurrent prostate cancer. J Surg Oncol Suppl. 1998;69(3):156–161
  40. Esper P, Mo F, Chodak G, Sinner M, Cella D, Pienta KJ. Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument. Urology. 1997;50:920–928
  41. Chang VT, Hwang SS, Feuerman M, Kasimis BS, Thaler H. The memorial symptom assessment scale short form (MSAS-SF). Cancer. 2000;89:1162–1171
  42. Mullin V, Cella D, Chang C, et al. Development of three African language translations of the FACT-G. Qual Life Res. 2000;9(2):139–149
  43. Poon RT, Fan ST, Wun CY, Lam BK, Chan FY, Wong J. A prospective longitudinal study of quality of life after resection of hepatocellular carcinoma. Arch Surg. 2001;136:693–699
  44. Holzner B, Kemmler G, Sperner-Unterweger B, et al. Quality of life measurement in oncology—a matter of the assessment instrument?. Eur J Cancer. 2001;37:2349–2356
  45. Coster S, Poole K, Fallowfield LJ. The validation of a quality of life scale to assess the impact of arm morbidity in breast cancer patients post-operatively. Breast Cancer Res Treat. 2001;68(3):273–282
  46. Sehlen S, Evans W, Johnson D, et al. Only sociodemographic variables predict quality of life after radiotherapy in patients with head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2002;52:779–783
  47. Shrader-Bogen CL, Kjellberg JL, McPherson CP, Murray CL. Quality of life and treatment outcomes: prostate carcinoma patients' perspectives after prostatectomy or radiation therapy. Cancer. 1997;79:1977–1986
  48. Peterman AH, Cella D, Mo F, McCain N. Psychometric validation of the revised Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) quality of life instrument. Qual Life Res. 1997;6(6):572–584
  49. Ribaudo JM, Cella D, Hahn EA, et al. Re-validation and shortening of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire. Qual Life Res. 2000;9:1137–1146
  50. Kopp M, Schweigkofler H, Holzner B, et al. Time after bone marrow transplantation as an important variable for quality of life—results of a cross-sectional investigation using two different instruments for quality-of-life assessment. Ann Hematol. 1998;77(1–2):27–32
  51. Lee WR, McQuellon RP, Case LD, deGuzman AF, McCullough DL. Early quality of life assessment in men treated with permanent source interstitial brachytherapy for clinically localized prostate cancer. J Urol. 1999;162:403–406
  52. Ramsey SD, Andersen MR, Etzioni R, et al. Quality of life in survivors of colorectal carcinoma. Cancer. 2000;88:1294–1303
  53. Lee WR, McQuellon RP, Harris-Henderson K, Case LD, McCullough DL. A preliminary analysis of health-related quality of life in the first year after permanent source interstitial brachytherapy (PIB) for clinically localized prostate cancer. Int J Radiat Oncol Biol Phys. 2000;46(1):77–81
  54. Robinson JW, Saliken JC, Donnelly BJ, Barnes P, Guyn L. Quality-of-life outcomes for men treated with cryosurgery for localized prostate carcinoma. Cancer. 1999;86:1793–1801
  55. Campbell BH, Marbella A, Layde PM. Quality of life and recurrence concern in survivors of head and neck cancer. Laryngoscope. 2000;110:895–906
  56. Abrams DI, Steinhart C, Frascino R. Epoetin alfa therapy for anaemia in HIV-infected patients: impact on quality of life. Int J STD AIDS. 2000;11(10):659–665
  57. Heinonen H, Volin L, Uutela A, Zevon M, Barrick C, Ruutu T. Quality of life and factors related to perceived satisfaction with quality of life after allogeneic bone marrow transplantation. Ann Hematol. 2001;80(3):137–143
  58. McQuellon RP, Loggie BW, Fleming RA, Russell G, Lehman AB, Rambo TD. Quality of life after intraperitoneal hyperthermic chemotherapy (IPHC) for peritoneal carcinomatosis. Eur J Surg Oncol. 2001;27(1):65–73
  59. Lee WR, Hall MC, McQuellon RP, Case LD, McCullough DL. A prospective quality-of-life study in men with clinically localized prostate carcinoma treated with radical prostatectomy, external beam radiotherapy, or interstitial brachytherapy. Int J Radiat Oncol Biol Phys. 2001;51:614–623
  60. Kornblith AB, Herndon JE, Zuckerman E, et al. The impact of docetaxel, estramustine, and low dose hydrocortisone on the quality of life of men with hormone refractory prostate cancer and their partners: a feasibility study. Ann Oncol. 2001;12:633–641
  61. Rose P, Yates P. Quality of life experienced by patients receiving radiation treatment for cancers of the head and neck. Cancer Nurs. 2001;24(4):255–263
  62. Hwang SS, Chang VT, Cogswell J, Kasimis BS. Clinical relevance of fatigue levels in cancer patients at a veterans administration medical center. Cancer. 2002;94:2481–2489
  63. Carter JR, Chen MD, Fowler JM, Carson LF, Twiggs LB. The effect of prolonged cycles of chemotherapy on quality of life in gynaecologic cancer patients. J Obstet Gynaecol Res. 1997;23(2):197–203
  64. Cella D, Hahn EA, Dineen K. Meaningful change in cancer-specific quality of life scores: differences between improvement and worsening. Qual Life Res. 2002;11(3):207–221
  65. John LD. Quality of life in patients receiving radiation therapy for non-small cell lung cancer. Oncol Nurs Forum. 2001;28:807–813
  66. Basen-Engquist K, Bodurka-Bevers D, Fitzgerald MA, et al. Reliability and validity of the functional assessment of cancer therapy-ovarian. J Clin Oncol. 2001;19:1809–1817
  67. List MA, Ritter-Sterr CA, Baker TM, et al. The Performance Status Scale for Head and Neck Cancer Patients and the Functional Assessment of Cancer Therapy-Head and Neck Scale. A study of utility and validity. Cancer. 1996;77:2294–2301
  68. Heffernan N, Cella D, Webster K, et al. Measuring health-related quality of life in patients with hepatobiliary cancers: the functional assessment of cancer therapy-hepatobiliary questionnaire. [see comments] J Clin Oncol. 2002;20:2229–2239
  69. McQuellon RP, Russell GB, Rambo TD, et al. Quality of life and psychological distress of bone marrow transplant recipients: the ‘time trajectory’ to recovery over the first year. Bone Marrow Transplant. 1998;21(5):477–486
  70. Overcash J, Extermann M, Parr J, Perry J, Balducci L. Validity and reliability of the FACT-G scale for use in the older person with cancer. Am J Clin Oncol. 2001;24(6):591–596
  71. Dow KH, Ferrell BR, Anello C. Quality-of-life changes in patients with thyroid cancer after withdrawal of thyroid hormone therapy. Thyroid. 1997;7:613–619
  72. Lev EL, Paul D, Owen SV. Age, self-efficacy, and change in patients' adjustment to cancer. [see comments] Cancer Pract. 1999;7(4):170–176
  73. Webster K, Cella D. Quality of life in patients with low-grade non-Hodgkin's lymphoma. Oncology (Huntington). 1998;12:697–714discussion 714
  74. Sharp LK. Quality of life in men with metastatic prostate cancer: psychometric properties of three instruments. Dissertation Abstracts Int B Sci Eng. 1997;58(4-B):
  75. Sehlen S, Hollenhorst H, Schymura B, et al. Radiotherapy: impact of quality of life and need for psychological care: results of a longitudinal study. Onkologie. 2000;23(6):565–570
  76. Carter J, Johnson P, Saltzman A, et al. Lack of adverse effect on quality of life of up to six cycles of chemotherapy in gynecologic cancer patients. Int J Gynecol Cancer. 1997;7(6):439–444
  77. Heinonen H, Volin L, Uutela A, Zevon M, Barrick C, Ruutu T. Gender-associated differences in the quality of life after allogeneic BMT. Bone Marrow Transplant. 2001;28:503–509
  78. Scieszka M, Zielinski M, Machalski M, Herman ZS. Quality of life in cancer patients treated by chemotherapy. Neoplasma. 2000;47(6):396–399
  79. Cooper SE, Mullin VC. Quality of life of cancer patients in underserved populations in South Africa. J Psychosoc Oncol. 2001;19(2):39–56
  80. Hinotsu A, Akaza H. Assessment of quality of life as an endpoint of cancer treatment, Gan to Kagaku Ryoho [Jpn J Cancer Chemother]. 2000;27:676–682
  81. Litwin MS, Hays RD, Fink A, et al. Quality-of-life outcomes in men treated for localized prostate cancer. [see comments] JAMA. 1995;273(2):129–135
  82. Knight SJ, Chmiel JS, Kuzel T, et al. Quality of life in metastatic prostate cancer among men of lower socioeconomic status: feasibility and criterion related validity of 3 measures. J Urol. 1998;160:1765–1769
  83. Wenzel LB, Fairclough DL, Brady MJ, et al. Age-related differences in the quality of life of breast carcinoma patients after treatment. Cancer. 1999;86:1768–1774
  84. Sutton LN, Radcliffe J, Goldwein JW, et al. Quality of life of adult survivors of germinomas treated with craniospinal irradiation. Neurosurgery. 1999;45:1292–1297discussion 1297–8
  85. Wickham RS, Rehwaldt M, Kefer C, et al. Taste changes experienced by patients receiving chemotherapy. Oncol Nurs Forum. 1999;26:697–706
  86. Esper P, Hampton JN, Smith DC, Pienta KJ. Quality-of-life evaluation in patients receiving treatment for advanced prostate cancer. Oncol Nurs Forum. 1999;26:107–112
  87. Riley BB, Perna R, Tate DG, Forchheimer M, Anderson C, Luera G. Types of spiritual well-being among persons with chronic illness: their relation to various forms of quality of life. Arch Phys Med Rehabil. 1998;79(3):258–264
  88. Lee WR, McQuellon RP, McCullough DL. A prospective analysis of patient-reported quality of life after prostate brachytherapy. Semin Urol Oncol. 2000;18(2):147–151
  89. List MA, Siston A, Haraf D, et al. Quality of life and performance in advanced head and neck cancer patients on concomitant chemoradiotherapy: a prospective examination. J Clin Oncol. 1999;17:1020–1028
  90. Schink JC, Weller E, Harris LS, et al. Outpatient taxol and carboplatin chemotherapy for suboptimally debulked epithelial carcinoma of the ovary results in improved quality of life: an Eastern Cooperative Oncology Group Phase II Study (E2E93). Cancer J. 2001;7(2):155–164
  91. Courneya KS, Friedenreich CM. Relationship between exercise during treatment and current quality of life among survivors of breast cancer. J Psychosoc Oncol. 1997;15(3/4):35–57
  92. Courneya KS, Friedenreich CM, Arthur K, Bobick TM. Physical exercise and quality of life in postsurgical colorectal cancer patients. Psychol Health Med. 1999;4(2):181–187
  93. Yount S, Cella D, Webster K, et al. Assessment of patient-reported clinical outcome in pancreatic and other hepatobiliary cancers; The FACT Hepatobiliary Symptom Index. J Pain Symptom Manage. 2002;24(1):32–44
  94. Robinson JW, Donnelly B, Saliken JC, Weber BA, Ernst S, Rewcastle JC. Quality of life and sexuality of men with prostate cancer 3 years after cryosurgery. Urology. 2002;60(1):12–18
  95. Lee SJ, Cook EF, Soiffer R, Antin JH. Development and validation of a scale to measure symptoms of chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2002;8(8):444–452
  96. Kallich JD, Tchekmedyian NS, Damiano AM, Shi J, Black JT, Erder MH. Psychological outcomes associated with anemia-related fatigue in cancer patients. Oncology (Huntington). 2002;16(9 Suppl 10):117–124
  97. Beaulac SM, McNair LA, Scott TE, LaMorte WW, Kavanah MT. Lymphedema and quality of life in survivors of early-stage breast cancer. Arch Surg. 2002;137:1253–1257
  98. Cella D, Eton DT, Lai JS, Peterman AH, Merkel DE. Combining anchor and distribution-based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy (FACT) anemia and fatigue scales. J Pain Symptom Manage. 2002;24(6):547–561
  99. Yost KJ, Eton DT. Combining distribution- and anchor-based approaches to determine minimally important differences: the FACIT experience. Eval Health Prof. 2005;28(2):172–191
  100. Schwartz CE, Bode R, Repucci N, Becker J, Sprangers MA, Fayers PM. The clinical significance of adaptation to changing health: a meta-analysis of response shift. Qual Life Res. 2006;15:1533–1550
  101. Klee MC, King MT, Machin D, Hansen HH. A clinical model for quality of life assessment in cancer patients receiving chemotherapy. Ann Oncol. 2000;11(1):23–30
  102. Schünemann HJ, Guyatt GH. Goodbye (M)CID! Hello MID, where do you come from?. [Commentary] Health Serv Res. 2005;40:593–597
  103. Wyrwich KW, Fihn SD, Tierney WM, Kroenke K, Babu AN, Wolinsky FD. Clinically important changes in health-related quality of life for patients with chronic obstructive pulmonary disease. An Expert Consensus Panel Report. J Gen Intern Med. 2003;18(3):196–202

PII: S0895-4356(09)00149-8

doi: 10.1016/j.jclinepi.2009.05.001

Journal of Clinical Epidemiology
Volume 63, Issue 3 , Pages 270-281 , March 2010