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Report from a National Cancer Institute (USA) workshop on quality of life assessment in cancer clinical trials

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Abstract

To promote the inclusion of quality of life (QOL) end-points in clinical research on cancer, the National Cancer Institute (USA) sponsored a workshop on QOL assessment in cancer clinical trials in July, 1990. Experts in clinical trials and QOL research formed four working groups to identify current areas of cancer treatment in which QOL end-points are most important; to discuss methodologic problems in QOL assessment; to address common problems in implementing clinical studies with QOL end-points; and to consider statistical issues in design, implementation, and data analysis. Recommendations made by the working groups are summarized in this paper.

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References

  1. Aaronson NK. Quality of life assessment in clinical trials: methodologic issues.Controlled Clin Trials 1989;10: 195S-208S.

    Google Scholar 

  2. Spilker B, ed.Quality of Life Assessment in Clinical Trials. New York: Raven Press, 1990.

    Google Scholar 

  3. Johnson JR, Temple R. Food and Drug Administration requirements for approval of new anticancer drugs.Cancer Treat Rep 1985;69: 1155–1157.

    Google Scholar 

  4. Moinpour CM, Feigl P, Metch B, et al. Quality of life endpoints in cancer clinical trials: Review and recommendations.J Natl Cancer Inst 1989;81: 485–495.

    Google Scholar 

  5. Skeel RT. Quality of life assessment in cancer clinical trials—it's time to catch up.J Natl Cancer Inst 1989;81: 472–473.

    Google Scholar 

  6. Selby P, Robertson B. Measurement of quality of life in patients with cancer.Cancer Surv 1987;6: 521–543.

    Google Scholar 

  7. Martini CJ, McDowell I. Health status: Patient and physician judgments.Health Services Research 1976;11: 508–515.

    Google Scholar 

  8. Wartman SA, Morlock LL, Malitz Fe, et al. Impact of divergent evaluations by physicians and patients of patients' complaints.Public Health Rep 1983;98: 141–145.

    Google Scholar 

  9. Slevin ML, Plant H, Lynch D, et al. Who should measure quality of life, the doctor or the patient?Br J Cancer 1988;57: 109–112.

    Google Scholar 

  10. Aaronson NK, Bakker W, Stewart AL, et al. Multidimensional approach to the measurement of quality of life in lung cancer clinical trials. In: Aaronson NK and Beckman J, eds.The Quality of Life of Cancer Patients. New York: Raven Press, 1987: 63–82.

    Google Scholar 

  11. Cella DF, Tulsky DS. Measuring quality of life today: Methodologic aspects.Oncology 1990;4: 29–38.

    Google Scholar 

  12. Schipper H, Clinch J, Powell V. Definitions and conceptual issues. In: Spilker B, ed.Quality of Life Assessment in Clinical Trials. New York: Raven Press, 1990: 11–24.

    Google Scholar 

  13. Kaplan RM, Anderson JP. The general health policy model: An integrated approach. In: Spilker B, ed.Quality of Life Assessment in Clinical Trials. New York: Raven Press, 1990: 131–149.

    Google Scholar 

  14. Patrick DL, Ericson P. What constitutes quality of life? Concepts and dimensions.Clin Nutr 1988;7: 53–63.

    Google Scholar 

  15. Patrick DL, Deyo RA. Generic and disease-specific measures in assessing health status and quality of life.Med Care 1989;27 (Suppl): S217–S232.

    Google Scholar 

  16. American Cancer Society.Cancer Facts and Figures—1990. Atlanta, Georgia: American Cancer Society, 1990.

    Google Scholar 

  17. National Cancer Institute: Surveillance, Epidemiology and End Results Program (SEER).Annual Cancer Statistics Review, November, 1984.

  18. National Center for Health Statistics, 1949–1951 to 1979–81.

  19. Mor V. Cancer patients' quality of life over the disease course: Lessons from the real world.J Chronic Dis 1987;40: 535–544.

    Google Scholar 

  20. Schmale AH, Morrow GR, Schmitt MH, et al. Well-being of cancer survivors.Psychosom Med 1983;45: 163–169.

    Google Scholar 

  21. Rieker PP, Fitzgerald EM, Kalish LA, et al. Psychosocial factors, curvative therapies, and behavioral outcomes: A comparison of testis cancer survivors and a control group of healthy men.Cancer 1989;64: 2399–2407.

    Google Scholar 

  22. Goldhirsch A, Gelber RD, Simes RJ, et al. For the Ludwig Breast Cancer Study Group. Costs and benefits of adjuvant therapy in breast cancer: A quality-adjusted survival analysis.J Clin Oncol 1989;7: 36–44.

    Google Scholar 

  23. Stewart AL, Hays RD, Ware JE Jr. The MOS short-form general health survey. Reliability and validity in a patient population.Med Care 1988;26: 724–735.

    Google Scholar 

  24. Stewart AL, Greenfield S, Hays RD, et al. Functional status and well-being of patients with chronic conditions. Results from the Medical Outcomes Study.JAMA 1989;262: 907–913.

    Google Scholar 

  25. Shag CAC, Ganz PA, Heinrich RL. Cancer Rehabilitation Evaluation System—short form (CARES): A cancer-specific rehabilitation and quality of life instrument.Cancer 1991;68: 1406–1413.

    Google Scholar 

  26. Schag CAC, Heinrich RL. Development of a comprehensive quality of life measurement tool: CARES.Oncology 1990;4: 135–138.

    Google Scholar 

  27. Ganz PA, Schag CAC, Cheng H. Assessing the quality of life—A study in newly diagnosed breast cancer patients.J Clin Epidemiol 1990;43: 75–86.

    Google Scholar 

  28. 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;2: 472–483.

    Google Scholar 

  29. Schipper H, Levitt M. Measuring quality of life: Risks and benefits.Cancer Treat Rep 1985;69: 1115–1123.

    Google Scholar 

  30. Aaronson NK, Bullinger M, Ahmedzai S. A modular approach to quality-of-life assessment in cancer clinical trials.Recent Results in Cancer Res 1988;111: 231–249.

    Google Scholar 

  31. Levine MN, Guyatt HG, Gent M, et al. Quality of life in Stage II breast cancer: An instrument for clinical trials.J Clin Oncol 1988;6: 1798–1810.

    Google Scholar 

  32. Derogatis LR. The Psychosocial Adjustment to Illness Scale (PAIS).J. Psychosom Res 1986;30: 77–91.

    Google Scholar 

  33. Derogatis LR, Lopez M.PAIS & PAIS-SR: Administration, scoring and procedures manual—I. Baltimore: Clinical Psychometric Research, 1983.

    Google Scholar 

  34. McCorkle R, Young KJ. Development of a symptom distress scale.Cancer Nurs 1978;1: 373–378.

    Google Scholar 

  35. McCorkle R, Benoliel JQ. Symptom distress, current concerns and mood disturbances after diagnosis of life-threatening disease.Soc Sci Med 1983;17: 431–438.

    Google Scholar 

  36. McCorkle R, Benoliel JQ, Donaldson G, et al. A randomized clinical trial of home nursing care for lung cancer patients.Cancer 1989;64: 1375–1382.

    Google Scholar 

  37. McCorkle R. The measurement of symptom distress.Semin Oncol Nurs 1987;3: 248–256.

    Google Scholar 

  38. Young KJ, Longman AJ. Quality of life and persons with melanoma: A pilot study.Cancer Nurs 1983;6: 219–225.

    Google Scholar 

  39. deHaas JCJM, Welvaart K. Quality of life after breast cancer surgery.J Surg Oncol 1985;28: 123–125.

    Google Scholar 

  40. deHaas JCJM, van Oosrom MA, Welvaart K. The effect of radical and conserving surgery on the quality of life of early breast cancer patients.Eur J Surg Oncol 1986;12: 337–342.

    Google Scholar 

  41. deHaas JCJM, Raatgever JW, van der Burg MEL, et al. Evaluation of the quality of life of patients with advanced ovarian cancer treated with combination therapy. In: Aaronson NK, Beckman J, eds.The Quality of Life of Cancer Patients. New York: Raven Press, 1987; 215–226.

    Google Scholar 

  42. deHaas JCJM, van Knippenberg FCE. Quality of life of cancer patients. Review of the literature. In Aaronson NK, Beckmann J, eds.The Quality of Life of Cancer Patients. New York: Raven Press, 1987; 167–182.

    Google Scholar 

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This article summarizes recommendations from the four working groups that comprised the workshop. Copies of the full reports are available from Dr Nayfield at the address above.

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Nayfield, S.G., Ganz, P.A., Moinpour, C.M. et al. Report from a National Cancer Institute (USA) workshop on quality of life assessment in cancer clinical trials. Qual Life Res 1, 203–210 (1992). https://doi.org/10.1007/BF00635619

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  • DOI: https://doi.org/10.1007/BF00635619

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