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. 1998 Jun 30;158(13):1727–1734.

Measuring health-related quality of life in clinical trials that evaluate the role of chemotherapy in cancer treatment

M Michael 1, I F Tannock 1
PMCID: PMC1229445  PMID: 9676550

Abstract

Quality of life is a subjective multidimentional concept that can be assessed by means of validated questionnaires completed by patients. The psychological effects of a diagnosis of cancer and the physical effects of the disease and its treating have a major impact on a patient's health-related quality of life. Much cancer treatment, especially chemotherapy for metastatic disease, is given for palliation. Palliation implies improvement in either the duration or quality of life remaining. However, treatment patients with common metastatic tumours to prolong life is generally unsuccessful, so improving quality of life is a more realistic goal. Most trials involve evaluating shrinkage of a tumour (i.e., tumour response), which does not imply a benefit to the patient. Few trials have assessed quality of life directly, although several validated instruments, described here, are available to quantify quality of life in cancer patients. These instruments represent a wide scope, from evaluating general health to assessing the quality of life of patients with specific types and stages of cancer. They respond to changes in clinical state and are strongly predictive of survival. Measures of quality of life should be incorporated in all clinical trials where treatment is palliative, and a simple, relevant measure of quality of life should be used as a (or the) primary outcome measure. Other measures of quality of life are important to ensure that gains in one area do not occur at the expense of others. A few large trials incorporating these principles have shown that chemotherapy can provide palliation for patients with advanced cancer.

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Selected References

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  1. Aaronson N. K., Ahmedzai S., Bergman B., Bullinger M., Cull A., Duez N. J., Filiberti A., Flechtner H., Fleishman S. B., de Haes J. C. 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 Mar 3;85(5):365–376. doi: 10.1093/jnci/85.5.365. [DOI] [PubMed] [Google Scholar]
  2. Batel-Copel L. M., Kornblith A. B., Batel P. C., Holland J. C. Do oncologists have an increasing interest in the quality of life of their patients? A literature review of the last 15 years. Eur J Cancer. 1997 Jan;33(1):29–32. doi: 10.1016/s0959-8049(96)00414-5. [DOI] [PubMed] [Google Scholar]
  3. Bergman B., Sullivan M., Sörenson S. Quality of life during chemotherapy for small cell lung cancer. II. A longitudinal study of the EORTC Core Quality of Life Questionnaire and comparison with the Sickness Impact Profile. Acta Oncol. 1992;31(1):19–28. doi: 10.3109/02841869209088260. [DOI] [PubMed] [Google Scholar]
  4. Bergner M., Bobbitt R. A., Pollard W. E., Martin D. P., Gilson B. S. The sickness impact profile: validation of a health status measure. Med Care. 1976 Jan;14(1):57–67. doi: 10.1097/00005650-197601000-00006. [DOI] [PubMed] [Google Scholar]
  5. Bjordal K., Kaasa S. Psychometric validation of the EORTC Core Quality of Life Questionnaire, 30-item version and a diagnosis-specific module for head and neck cancer patients. Acta Oncol. 1992;31(3):311–321. doi: 10.3109/02841869209108178. [DOI] [PubMed] [Google Scholar]
  6. Brady M. J., Cella D. F., Mo F., Bonomi A. E., Tulsky D. S., Lloyd S. R., Deasy S., Cobleigh M., Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974–986. doi: 10.1200/JCO.1997.15.3.974. [DOI] [PubMed] [Google Scholar]
  7. Burris H. A., 3rd, Moore M. J., Andersen J., Green M. R., Rothenberg M. L., Modiano M. R., Cripps M. C., Portenoy R. K., Storniolo A. M., Tarassoff P. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403–2413. doi: 10.1200/JCO.1997.15.6.2403. [DOI] [PubMed] [Google Scholar]
  8. Campbell A. Subjective measures of well-being. Am Psychol. 1976 Feb;31(2):117–124. doi: 10.1037//0003-066x.31.2.117. [DOI] [PubMed] [Google Scholar]
  9. Cella D. F., Tulsky D. S., Gray G., Sarafian B., Linn E., Bonomi A., Silberman M., Yellen S. B., Winicour P., Brannon J. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570–579. doi: 10.1200/JCO.1993.11.3.570. [DOI] [PubMed] [Google Scholar]
  10. Chlebowski R. T., Lillington L. M. A decade of breast cancer clinical investigation: results as reported in the Program/Proceedings of the American Society of Clinical Oncology. J Clin Oncol. 1994 Sep;12(9):1789–1795. doi: 10.1200/JCO.1994.12.9.1789. [DOI] [PubMed] [Google Scholar]
  11. Coates A., Gebski V., Signorini D., Murray P., McNeil D., Byrne M., Forbes J. F. Prognostic value of quality-of-life scores during chemotherapy for advanced breast cancer. Australian New Zealand Breast Cancer Trials Group. J Clin Oncol. 1992 Dec;10(12):1833–1838. doi: 10.1200/JCO.1992.10.12.1833. [DOI] [PubMed] [Google Scholar]
  12. Coates A., Glasziou P., McNeil D. On the receiving end--III. Measurement of quality of life during cancer chemotherapy. Ann Oncol. 1990;1(3):213–217. doi: 10.1093/oxfordjournals.annonc.a057724. [DOI] [PubMed] [Google Scholar]
  13. Coates A., Porzsolt F., Osoba D. Quality of life in oncology practice: prognostic value of EORTC QLQ-C30 scores in patients with advanced malignancy. Eur J Cancer. 1997 Jun;33(7):1025–1030. doi: 10.1016/s0959-8049(97)00049-x. [DOI] [PubMed] [Google Scholar]
  14. Coates A., Thomson D., McLeod G. R., Hersey P., Gill P. G., Olver I. N., Kefford R., Lowenthal R. M., Beadle G., Walpole E. Prognostic value of quality of life scores in a trial of chemotherapy with or without interferon in patients with metastatic malignant melanoma. Eur J Cancer. 1993;29A(12):1731–1734. doi: 10.1016/0959-8049(93)90115-v. [DOI] [PubMed] [Google Scholar]
  15. Cohen S. R., Mount B. M., Bruera E., Provost M., Rowe J., Tong K. Validity of the McGill Quality of Life Questionnaire in the palliative care setting: a multi-centre Canadian study demonstrating the importance of the existential domain. Palliat Med. 1997 Jan;11(1):3–20. doi: 10.1177/026921639701100102. [DOI] [PubMed] [Google Scholar]
  16. Cohen S. R., Mount B. M., Tomas J. J., Mount L. F. Existential well-being is an important determinant of quality of life. Evidence from the McGill Quality of Life Questionnaire. Cancer. 1996 Feb 1;77(3):576–586. doi: 10.1002/(SICI)1097-0142(19960201)77:3<576::AID-CNCR22>3.0.CO;2-0. [DOI] [PubMed] [Google Scholar]
  17. Daut R. L., Cleeland C. S., Flanery R. C. Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain. 1983 Oct;17(2):197–210. doi: 10.1016/0304-3959(83)90143-4. [DOI] [PubMed] [Google Scholar]
  18. Donovan K., Sanson-Fisher R. W., Redman S. Measuring quality of life in cancer patients. J Clin Oncol. 1989 Jul;7(7):959–968. doi: 10.1200/JCO.1989.7.7.959. [DOI] [PubMed] [Google Scholar]
  19. Fayers P. M., Hopwood P., Harvey A., Girling D. J., Machin D., Stephens R. Quality of life assessment in clinical trials--guidelines and a checklist for protocol writers: the U.K. Medical Research Council experience. MRC Cancer Trials Office. Eur J Cancer. 1997 Jan;33(1):20–28. doi: 10.1016/s0959-8049(96)00412-1. [DOI] [PubMed] [Google Scholar]
  20. Fayers P. M., Jones D. R. Measuring and analysing quality of life in cancer clinical trials: a review. Stat Med. 1983 Oct-Dec;2(4):429–446. doi: 10.1002/sim.4780020402. [DOI] [PubMed] [Google Scholar]
  21. Fishman B., Pasternak S., Wallenstein S. L., Houde R. W., Holland J. C., Foley K. M. The Memorial Pain Assessment Card. A valid instrument for the evaluation of cancer pain. Cancer. 1987 Sep 1;60(5):1151–1158. doi: 10.1002/1097-0142(19870901)60:5<1151::aid-cncr2820600538>3.0.co;2-g. [DOI] [PubMed] [Google Scholar]
  22. Ganz P. A., Haskell C. M., Figlin R. A., La Soto N., Siau J. Estimating the quality of life in a clinical trial of patients with metastatic lung cancer using the Karnofsky performance status and the Functional Living Index--Cancer. Cancer. 1988 Feb 15;61(4):849–856. doi: 10.1002/1097-0142(19880215)61:4<849::aid-cncr2820610435>3.0.co;2-b. [DOI] [PubMed] [Google Scholar]
  23. Gotay C. C., Korn E. L., McCabe M. S., Moore T. D., Cheson B. D. Quality-of-life assessment in cancer treatment protocols: research issues in protocol development. J Natl Cancer Inst. 1992 Apr 15;84(8):575–579. doi: 10.1093/jnci/84.8.575. [DOI] [PubMed] [Google Scholar]
  24. Guyatt G. H., Feeny D. H., Patrick D. L. Measuring health-related quality of life. Ann Intern Med. 1993 Apr 15;118(8):622–629. doi: 10.7326/0003-4819-118-8-199304150-00009. [DOI] [PubMed] [Google Scholar]
  25. Guyatt G. H., Thompson P. J., Berman L. B., Sullivan M. J., Townsend M., Jones N. L., Pugsley S. O. How should we measure function in patients with chronic heart and lung disease? J Chronic Dis. 1985;38(6):517–524. doi: 10.1016/0021-9681(85)90035-9. [DOI] [PubMed] [Google Scholar]
  26. Guyatt G. H., Townsend M., Pugsley S. O., Keller J. L., Short H. D., Taylor D. W., Newhouse M. T. Bronchodilators in chronic air-flow limitation. Effects on airway function, exercise capacity, and quality of life. Am Rev Respir Dis. 1987 May;135(5):1069–1074. doi: 10.1164/arrd.1987.135.5.1069. [DOI] [PubMed] [Google Scholar]
  27. Hayman J. A., Fairclough D. L., Harris J. R., Weeks J. C. Patient preferences concerning the trade-off between the risks and benefits of routine radiation therapy after conservative surgery for early-stage breast cancer. J Clin Oncol. 1997 Mar;15(3):1252–1260. doi: 10.1200/JCO.1997.15.3.1252. [DOI] [PubMed] [Google Scholar]
  28. Higginson I. J., McCarthy M. A comparison of two measures of quality of life: their sensitivity and validity for patients with advanced cancer. Palliat Med. 1994 Oct;8(4):282–290. doi: 10.1177/026921639400800403. [DOI] [PubMed] [Google Scholar]
  29. Hollen P. J., Gralla R. J., Kris M. G., Potanovich L. M. Quality of life assessment in individuals with lung cancer: testing the Lung Cancer Symptom Scale (LCSS). Eur J Cancer. 1993;29A Suppl 1:S51–S58. doi: 10.1016/s0959-8049(05)80262-x. [DOI] [PubMed] [Google Scholar]
  30. Hutchinson T. A., Boyd N. F., Feinstein A. R., Gonda A., Hollomby D., Rowat B. Scientific problems in clinical scales, as demonstrated in the Karnofsky index of performance status. J Chronic Dis. 1979;32(9-10):661–666. doi: 10.1016/0021-9681(79)90096-1. [DOI] [PubMed] [Google Scholar]
  31. Jaeschke R., Guyatt G. H., Keller J., Singer J. Interpreting changes in quality-of-life score in N of 1 randomized trials. Control Clin Trials. 1991 Aug;12(4 Suppl):226S–233S. doi: 10.1016/s0197-2456(05)80026-1. [DOI] [PubMed] [Google Scholar]
  32. Jaeschke R., Singer J., Guyatt G. H. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989 Dec;10(4):407–415. doi: 10.1016/0197-2456(89)90005-6. [DOI] [PubMed] [Google Scholar]
  33. King M. T., Dobson A. J., Harnett P. R. A comparison of two quality-of-life questionnaires for cancer clinical trials: the functional living index--cancer (FLIC) and the quality of life questionnaire core module (QLQ-C30). J Clin Epidemiol. 1996 Jan;49(1):21–29. doi: 10.1016/0895-4356(96)89258-4. [DOI] [PubMed] [Google Scholar]
  34. Levine M. N., Guyatt G. H., Gent M., De Pauw S., Goodyear M. D., Hryniuk W. M., Arnold A., Findlay B., Skillings J. R., Bramwell V. H. Quality of life in stage II breast cancer: an instrument for clinical trials. J Clin Oncol. 1988 Dec;6(12):1798–1810. doi: 10.1200/JCO.1988.6.12.1798. [DOI] [PubMed] [Google Scholar]
  35. Moinpour C. M., Feigl P., Metch B., Hayden K. A., Meyskens F. L., Jr, Crowley J. Quality of life end points in cancer clinical trials: review and recommendations. J Natl Cancer Inst. 1989 Apr 5;81(7):485–495. doi: 10.1093/jnci/81.7.485. [DOI] [PubMed] [Google Scholar]
  36. Oken M. M., Creech R. H., Tormey D. C., Horton J., Davis T. E., McFadden E. T., Carbone P. P. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649–655. [PubMed] [Google Scholar]
  37. Osoba D., Dancey J., Zee B., Myles J., Pater J. Health-related quality-of-life studies of the National Cancer Institute of Canada Clinical Trials Group. J Natl Cancer Inst Monogr. 1996;(20):107–111. [PubMed] [Google Scholar]
  38. Osoba D. Lessons learned from measuring health-related quality of life in oncology. J Clin Oncol. 1994 Mar;12(3):608–616. doi: 10.1200/JCO.1994.12.3.608. [DOI] [PubMed] [Google Scholar]
  39. Osoba D., Rodrigues G., Myles J., Zee B., Pater J. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol. 1998 Jan;16(1):139–144. doi: 10.1200/JCO.1998.16.1.139. [DOI] [PubMed] [Google Scholar]
  40. 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 Oct;3(5):353–364. doi: 10.1007/BF00451727. [DOI] [PubMed] [Google Scholar]
  41. Priestman T. J., Baum M. Evaluation of quality of life in patients receiving treatment for advanced breast cancer. Lancet. 1976 Apr 24;1(7965):899–900. doi: 10.1016/s0140-6736(76)92112-7. [DOI] [PubMed] [Google Scholar]
  42. Sadura A., Pater J., Osoba D., Levine M., Palmer M., Bennett K. Quality-of-life assessment: patient compliance with questionnaire completion. J Natl Cancer Inst. 1992 Jul 1;84(13):1023–1026. doi: 10.1093/jnci/84.13.1023. [DOI] [PubMed] [Google Scholar]
  43. Schipper H., Clinch J., McMurray A., Levitt M. Measuring the quality of life of cancer patients: the Functional Living Index-Cancer: development and validation. J Clin Oncol. 1984 May;2(5):472–483. doi: 10.1200/JCO.1984.2.5.472. [DOI] [PubMed] [Google Scholar]
  44. Selby P. J., Chapman J. A., Etazadi-Amoli J., Dalley D., Boyd N. F. The development of a method for assessing the quality of life of cancer patients. Br J Cancer. 1984 Jul;50(1):13–22. doi: 10.1038/bjc.1984.134. [DOI] [PMC free article] [PubMed] [Google Scholar]
  45. Slevin M. L., Plant H., Lynch D., Drinkwater J., Gregory W. M. Who should measure quality of life, the doctor or the patient? Br J Cancer. 1988 Jan;57(1):109–112. doi: 10.1038/bjc.1988.20. [DOI] [PMC free article] [PubMed] [Google Scholar]
  46. Spitzer W. O., Dobson A. J., Hall J., Chesterman E., Levi J., Shepherd R., Battista R. N., Catchlove B. R. Measuring the quality of life of cancer patients: a concise QL-index for use by physicians. J Chronic Dis. 1981;34(12):585–597. doi: 10.1016/0021-9681(81)90058-8. [DOI] [PubMed] [Google Scholar]
  47. Sprangers M. A., Groenvold M., Arraras J. I., Franklin J., te Velde A., Muller M., Franzini L., Williams A., de Haes H. C., Hopwood P. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996 Oct;14(10):2756–2768. doi: 10.1200/JCO.1996.14.10.2756. [DOI] [PubMed] [Google Scholar]
  48. Stephens R. J., Hopwood P., Girling D. J., Machin D. Randomized trials with quality of life endpoints: are doctors' ratings of patients' physical symptoms interchangeable with patients' self-ratings? Qual Life Res. 1997 Apr;6(3):225–236. doi: 10.1023/a:1026458604826. [DOI] [PubMed] [Google Scholar]
  49. Tannock I. F., Osoba D., Stockler M. R., Ernst D. S., Neville A. J., Moore M. J., Armitage G. R., Wilson J. J., Venner P. M., Coppin C. M. Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. J Clin Oncol. 1996 Jun;14(6):1756–1764. doi: 10.1200/JCO.1996.14.6.1756. [DOI] [PubMed] [Google Scholar]
  50. Tannock I., Gospodarowicz M., Meakin W., Panzarella T., Stewart L., Rider W. Treatment of metastatic prostatic cancer with low-dose prednisone: evaluation of pain and quality of life as pragmatic indices of response. J Clin Oncol. 1989 May;7(5):590–597. doi: 10.1200/JCO.1989.7.5.590. [DOI] [PubMed] [Google Scholar]
  51. Ware J. E., Jr Methodology in behavioral and psychosocial cancer research. Conceptualizing disease impact and treatment outcomes. Cancer. 1984 May 15;53(10 Suppl):2316–2326. doi: 10.1002/cncr.1984.53.s10.2316. [DOI] [PubMed] [Google Scholar]
  52. Ware J. E., Jr, Sherbourne C. D. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473–483. [PubMed] [Google Scholar]
  53. Warr D., McKinney S., Tannock I. Influence of measurement error on assessment of response to anticancer chemotherapy: proposal for new criteria of tumor response. J Clin Oncol. 1984 Sep;2(9):1040–1046. doi: 10.1200/JCO.1984.2.9.1040. [DOI] [PubMed] [Google Scholar]
  54. Weeks J. Quality-of-life assessment: performance status upstaged? J Clin Oncol. 1992 Dec;10(12):1827–1829. doi: 10.1200/JCO.1992.10.12.1827. [DOI] [PubMed] [Google Scholar]

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