Logo of cmajCMAJ Information for AuthorsCMAJ Home Page
CMAJ. 1998 Jun 30; 158(13): 1727–1734.
PMCID: PMC1229445

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


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.

Full Text

The Full Text of this article is available as a PDF (188K).

Selected References

These references are in PubMed. This may not be the complete list of references from this article.
  • Osoba D. Lessons learned from measuring health-related quality of life in oncology. J Clin Oncol. 1994 Mar;12(3):608–616. [PubMed]
  • Chlebowski RT, Lillington LM. 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. [PubMed]
  • Guyatt GH, Thompson PJ, Berman LB, Sullivan MJ, Townsend M, Jones NL, Pugsley SO. How should we measure function in patients with chronic heart and lung disease? J Chronic Dis. 1985;38(6):517–524. [PubMed]
  • Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med. 1993 Apr 15;118(8):622–629. [PubMed]
  • 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]
  • 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. [PubMed]
  • 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. [PubMed]
  • Tannock IF, Osoba D, Stockler MR, Ernst DS, Neville AJ, Moore MJ, Armitage GR, Wilson JJ, Venner PM, Coppin CM, et al. 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. [PubMed]
  • 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. [PubMed]
  • Cohen SR, Mount BM, 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. [PubMed]
  • Spitzer WO, Dobson AJ, Hall J, Chesterman E, Levi J, Shepherd R, Battista RN, Catchlove BR. Measuring the quality of life of cancer patients: a concise QL-index for use by physicians. J Chronic Dis. 1981;34(12):585–597. [PubMed]
  • Campbell A. Subjective measures of well-being. Am Psychol. 1976 Feb;31(2):117–124. [PubMed]
  • Stephens RJ, Hopwood P, Girling DJ, 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. [PubMed]
  • Slevin ML, Plant H, Lynch D, Drinkwater J, Gregory WM. Who should measure quality of life, the doctor or the patient? Br J Cancer. 1988 Jan;57(1):109–112. [PMC free article] [PubMed]
  • 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. [PubMed]
  • Donovan K, Sanson-Fisher RW, Redman S. Measuring quality of life in cancer patients. J Clin Oncol. 1989 Jul;7(7):959–968. [PubMed]
  • Cohen SR, Mount BM, Tomas JJ, Mount LF. 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. [PubMed]
  • Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649–655. [PubMed]
  • Bergner M, Bobbitt RA, Pollard WE, Martin DP, Gilson BS. The sickness impact profile: validation of a health status measure. Med Care. 1976 Jan;14(1):57–67. [PubMed]
  • Ware JE, Jr, Sherbourne CD. 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]
  • Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, 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 Mar 3;85(5):365–376. [PubMed]
  • Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570–579. [PubMed]
  • Levine MN, Guyatt GH, Gent M, De Pauw S, Goodyear MD, Hryniuk WM, Arnold A, Findlay B, Skillings JR, Bramwell VH, et al. Quality of life in stage II breast cancer: an instrument for clinical trials. J Clin Oncol. 1988 Dec;6(12):1798–1810. [PubMed]
  • Selby PJ, Chapman JA, Etazadi-Amoli J, Dalley D, Boyd NF. The development of a method for assessing the quality of life of cancer patients. Br J Cancer. 1984 Jul;50(1):13–22. [PMC free article] [PubMed]
  • Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, 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. [PubMed]
  • Sprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, Franzini L, Williams A, de Haes HC, Hopwood P, et al. 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. [PubMed]
  • Hollen PJ, Gralla RJ, Kris MG, Potanovich LM. 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. [PubMed]
  • 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. [PubMed]
  • Moinpour CM, Feigl P, Metch B, Hayden KA, Meyskens FL, 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. [PubMed]
  • Fayers PM, Jones DR. Measuring and analysing quality of life in cancer clinical trials: a review. Stat Med. 1983 Oct-Dec;2(4):429–446. [PubMed]
  • Fayers PM, Hopwood P, Harvey A, Girling DJ, 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. [PubMed]
  • 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. [PubMed]
  • Ganz PA, Haskell CM, Figlin RA, 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. [PubMed]
  • Ware JE., Jr Methodology in behavioral and psychosocial cancer research. Conceptualizing disease impact and treatment outcomes. Cancer. 1984 May 15;53(10 Suppl):2316–2326. [PubMed]
  • Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989 Dec;10(4):407–415. [PubMed]
  • Jaeschke R, Guyatt GH, 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. [PubMed]
  • Guyatt GH, Townsend M, Pugsley SO, Keller JL, Short HD, Taylor DW, Newhouse MT. 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. [PubMed]
  • 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. [PubMed]
  • Weeks J. Quality-of-life assessment: performance status upstaged? J Clin Oncol. 1992 Dec;10(12):1827–1829. [PubMed]
  • Hutchinson TA, Boyd NF, Feinstein AR, 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. [PubMed]
  • King MT, Dobson AJ, Harnett PR. 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. [PubMed]
  • 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. [PubMed]
  • Gotay CC, Korn EL, McCabe MS, Moore TD, Cheson BD. Quality-of-life assessment in cancer treatment protocols: research issues in protocol development. J Natl Cancer Inst. 1992 Apr 15;84(8):575–579. [PubMed]
  • Hayman JA, Fairclough DL, Harris JR, Weeks JC. 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. [PubMed]
  • Batel-Copel LM, Kornblith AB, Batel PC, Holland JC. 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. [PubMed]
  • Burris HA, 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, et al. 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. [PubMed]
  • Fishman B, Pasternak S, Wallenstein SL, Houde RW, Holland JC, Foley KM. The Memorial Pain Assessment Card. A valid instrument for the evaluation of cancer pain. Cancer. 1987 Sep 1;60(5):1151–1158. [PubMed]
  • Priestman TJ, Baum M. Evaluation of quality of life in patients receiving treatment for advanced breast cancer. Lancet. 1976 Apr 24;1(7965):899–900. [PubMed]
  • Coates A, Gebski V, Signorini D, Murray P, McNeil D, Byrne M, Forbes JF. 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. [PubMed]
  • Coates A, Thomson D, McLeod GR, Hersey P, Gill PG, Olver IN, Kefford R, Lowenthal RM, 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. [PubMed]
  • 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. [PubMed]
  • 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. [PubMed]
  • Higginson IJ, 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. [PubMed]
  • Daut RL, Cleeland CS, Flanery RC. Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain. 1983 Oct;17(2):197–210. [PubMed]

Articles from CMAJ : Canadian Medical Association Journal are provided here courtesy of Canadian Medical Association


Save items

Related citations in PubMed

See reviews...See all...

Cited by other articles in PMC

See all...


  • MedGen
    Related information in MedGen
  • PubMed
    PubMed citations for these articles

Recent Activity

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...