Quality of Life Assessment in Southwest Oncology Group Clinical Trials: Translating and Validating a Spanish Questionnaire

  • C. M. Moinpour
Conference paper

Summary

This paper describes the approach used by the Southwest Oncology Group (SWOG) to assess quality of life in cancer clinical trials. SWOG is a cooperative group in the United States that conducts clinical trials to evaluate new cancer treatments. Quality of life is assessed in selected trials, particularly those in which treatment aims are expected to differ minimally with respect to traditional endpoints and palliative objectives are of concern. SWOG’s assessment approach is component-based and includes both generic and cancer-specific quality of life scales; the Medical Outcomes Study Short Form scales and the Symptom Distress Scale are the main standardized instruments included in the SWOG Quality of Life Questionnaire. Currently there is only an English version of SWOG’s questionnaire. Hispanic Americans are the second largest minority group in the United States. Many Hispanics prefer interviews to be conducted in Spanish and many who can speak English do not necessarily prefer using English for reading or writing activities. Therefore, to avoid continuing to exclude Hispanic patients unable to complete questionnaires in English, we will be translating the SWOG Quality of Life Questionnaire into Spanish and conducting necessary validation research. A summary of the research plan is provided.

Keywords

Toxicity Leukemia Insurance Coverage Income Oncol 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Aaronson NK, Bullinger M, Ahmedzai S (1988) A modular approach to quality of life assessment in cancer clinical trials. Recent Results Cancer Res 111: 231–249PubMedGoogle Scholar
  2. Aaronson NK, Ahmedzai S, Bullinger M, Crabeels D, Estape J, Filiberti A, Flechtner H, Frick U, Hurny C, Kaasa S, Klee M, Mastilica M, Osoba D, Pfausler B, Razavi D, Rofe PBC, Schraub S, Sullivan M, Thkeda F (1991) for the EORTC Study Group on Quality of Life. The EORTC Core Quality-of-Life Questionnaire: Interim results of an international field study. In: Osoba D (ed) Effect of cancer on quality of life. Boca Raton, FL, CRC Press, Inc, pp 293–305Google Scholar
  3. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JCJM, Kaasa S, Klee M, Osoba D, Razavi D, Rofe PB, Schraub S, Sneeuw K, Sullivan M, Takeda F for the European Organization for Research and Treatment of Cancer Study Group on Quality of Life (1993) 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 85: 365–376PubMedCrossRefGoogle Scholar
  4. American Cancer Society. ACS Survey finds need for education program among Hispanic Americans (1985) Cancer Lett 11, 6Google Scholar
  5. Andrews FM, Withey SB (eds) (1976) Social indicators of well-being. New York, Plenum PressGoogle Scholar
  6. Barofsky I, Sugarbaker PH (1990) Cancer. In: Spilker B (ed) Quality of life assessment in clinical trials New York, Raven Press, pp 419–439Google Scholar
  7. Berkanovic E (1980) The effect of inadequate language translation on Hispanic’s responses to health surveys. Am J Public Health 70: 1273–1281PubMedCrossRefGoogle Scholar
  8. Berry JW (1980) Acculturation as varieties of adaptation. In: Padilla AM (ed) Acculturation: Theory, models, and some new findings. Boulder, CO, Westview Press, pp 9–25Google Scholar
  9. Boring CC, Squires TS, Tong T (1992) Cancer Statistics CA 42: 19–38Google Scholar
  10. Byrne M (1992) Cancer chemotherapy and quality of life. Cancer trials should include measures of patient’s wellbeing. Brit Med J 304: 1523–1524PubMedCrossRefGoogle Scholar
  11. Campbell A, Converse PE, Rodgers WL (eds) (1976) The quality of American life. New York, Sage.Google Scholar
  12. Cancer Statistics Review (1983-1987) National Cancer Institute Division of Cancer Prevention and Control Surveillance Program. In: Ries LAB, Hankey BF, Edwards BK (eds) NIH Publication No. 90–2789Google Scholar
  13. Cella DF, Thlsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, Eckberg K, Lloyd S, Purl S, Blendowski C, Goodman M, Barnicle M, Stewart I, McHale M, Bonomi P, Kaplan E, Thylor S, Thomas CR, Harris J (1992) The Functional Assessment of Cancer Therapy (FACT) Scale: Development and validation of the general measure. J Clin Oncol 11: 570–579Google Scholar
  14. Cuellar I, Harris LC, Jasso R (1980) An acculturation scale for Mexican American normal and clinical populations. Hispanic J Behav Sci 2: 199–217Google Scholar
  15. Delgado JL, Johnson CL, Roy I, Trevino FM (1990) I. Hispanic health and nutrition examination survey: Methodological considerations. Am J Publish Health 80 (Suppl): 6–10CrossRefGoogle Scholar
  16. Deyo RA (1984) Pitfalls in measuring the health status of Mexican Americans: Comparative validity of the English and Spanish Sickness Impact Profile. Clin Res 32: 293AGoogle Scholar
  17. Deyo RA, Diehl AK, Hazuda H, Stern MP (1985) A simple language-based acculturation scale for Mexican Americans: Validaton and application to health care research. Am J Public Health 75: 51–55PubMedCrossRefGoogle Scholar
  18. FDA/NCI Working Group on clinical trials endpoints agrees on broader approval criteria: Survival, response rates, time to failure, life quality (1990) Clin Cancer Lett 13: 1–7Google Scholar
  19. Frank-Stromborg M (1991) Changing demographics in the United States. Implications for health professionals. Cancer 67: 1772–1778PubMedGoogle Scholar
  20. Ganz PA, Schlag CAC, Lee JJ, Sim MS (1992) The CARES: A generic measure of healthrelated quality of life for patients with cancer. Quality Life Res 1: 19–29CrossRefGoogle Scholar
  21. Gotay CC, Korn EL, McCabe MS, Moore TD, Cheson BD (1992a) Building quality of life assessment into cancer treatment studies. Oncology 6: 25–28PubMedGoogle Scholar
  22. Gotay CC, Korn EL, McCabe MS, Moore TD, Cheson BD (1992b) Quality of life assessment in cancer treatment protocols: Research issues in protocol development. J Natl Cancer Inst 84: 575–579PubMedCrossRefGoogle Scholar
  23. Hendricson WD, Russell IJ, Prihoda TJ, Jacobson JM, Rogan A, Bishop GD (1989) An approach to developing a valid Spanish language translation of a health-status questionnaire. Med Care 27: 959–966PubMedCrossRefGoogle Scholar
  24. Kaplan M, Anderson JP (1988) A general health policy model: Update and applications. Health Services Res, 23, 203–205Google Scholar
  25. Knafl K, Howard M (1984) Interpreting and reporting qualitative research. Res Nurs Health 7: 17–24PubMedCrossRefGoogle Scholar
  26. Marin G, Marin BV (1991) Research with Hispanic populations. Applied Social Research Methods Series. Volume 23. Newbury Park, CA, Sage PublicationsGoogle Scholar
  27. Marin G, Perez-Stable EJ, Marin BV (1989) Cigarette smoking among San Francisco Hispanics: The role of acculturation and gender. Am J Pub Health 79: 196–199CrossRefGoogle Scholar
  28. Marin G, Sabogal F, Marin BV, Otero-Sabogal R, Perez-Stable EJ (1987) Development of a short acculturation scale for Hispanics. Hispanic J Behav Sci 9: 183–205CrossRefGoogle Scholar
  29. McCorkle R (1987) The measurement of symptom distress. Seminars Oncol Nursing 3: 248–256CrossRefGoogle Scholar
  30. McCorkle R, Benoliel JQ (1983) Symptom distress, current concerns and mood disturbance after diagnosis of life-threatening disease. Social Sci Med 17: 431–438CrossRefGoogle Scholar
  31. McCorkle R, Benoliel JQ, Donaldson G, Georgiadou F, Moinpour CM, Goodell B (1989) A randomized clinical trial of home nursing care for lung cancer patients. Cancer 64: 1375–1382PubMedCrossRefGoogle Scholar
  32. Moinpour CM, Feigl P, Metch B, Hayden KA, Meyskens FL, Crowley J (1989) Quality of life end points in cancer clinical trials: review and recommendations. J Natl Cancer Inst 81: 485–495PubMedCrossRefGoogle Scholar
  33. Moinpour CM, Savage M, Hayden KA, Sawyers J, Upchurch C (1993) Quality of life assessment in cancer clinical trials. In: Dimsdale JE, Baum A (eds) Quality of life in behavioral medicine research. Hillsdale NJ, Lawrence Erlbaum Associates, in pressGoogle Scholar
  34. National Cancer Institute, National Center for Nursing Research (1992). Quality of Life Assessment in Special Populations. RFA Number: CA/NR-92-27. In: Catalog of Federal Domestic Assistance No. 93.399, Cancer Control Research, and No. 93.361, Nursing Research, 1992Google Scholar
  35. National Institutes of Health Consensus Conference Statement: Treatment of Early-stage Breast Cancer. (June 18–21, 1990) Bethesda, MD: National Institutes of HealthGoogle Scholar
  36. Nayfield SG, Ganz PA, Moinpour CM, Cella DF, Hailey BJ (1992) Report from a National Cancer Institute (USA) workshop on quality of life assessment in cancer clinical trials. Quality Life Res 1: 203–210CrossRefGoogle Scholar
  37. Nyamathi A, Shuler P (1990) Focus group interview: A research technique for informed nursing practice. J Advanced Nurs 15: 1281–1288CrossRefGoogle Scholar
  38. Osoba D (ed) (1991) Effect of cancer on quality of life. Boca Raton, FL, CRC Press, Inc.Google Scholar
  39. Padilla AM (1980) The role of cultural awareness and ethnic loyalty in acculturation. In: Padilla AM (ed) Acculturation: Theory, models and some new findings. Boulder, CO. Westview Press, pp 47–84Google Scholar
  40. Padilla GV, Ferrell B, Grant MM, Rhiner M (1990) Defining the content domain of quality of life for cancer patients with pain. Cancer Nursing 13: 108–115PubMedCrossRefGoogle Scholar
  41. Patrick DL, Deyo RA (1989) Generic and disease-specific measures in assessing health status and quality of life. Med Care 27: S217-S232PubMedCrossRefGoogle Scholar
  42. Patrick DL, Erickson P (1988) What constitutes quality of life? Concepts and dimensions. Clin Nutrition 7: 53–63Google Scholar
  43. Ramirez AG, Cousins IH, Santos Y, Supik ID (1986) A media-based acculturation scale for Mexican Americans: application to public health education programs. Fam Community Health 9: 63–71Google Scholar
  44. Ramirez AG, MacKellar DA, Gallion K (1988) Reaching minority audiences: A major challenge in cancer reduction. Cancer Bull 40: 334–343Google Scholar
  45. Ramirez AG, McAlister AL (1988) Mass media campaign-A Su Salud. Preventive Med 17: 608–621CrossRefGoogle Scholar
  46. Schag CAC, Ganz PA, Heinrich RL (1991) CAncer Rehabilitation Evaluation System-Short Form (CARES-SF): A cancer specific rehabilitation and quality of life instrument. Cancer 68: 1406–1413PubMedCrossRefGoogle Scholar
  47. Selby PJ, Campbell JE, Chapman JA, Etazadi-Amoli J, Boyd NF (1984a) Measurement of the quality of life in patients with breast cancer. Rev Endocrine-Related Cancer 14 (Suppl): 235–247Google Scholar
  48. Selby PI, Chapman JAW, Etazadi-Amoli J, Dalley D, Boyd NF (1984b) The development of a method for assessing the quality of life of cancer patients. Brit J Cancer 50: 13–22PubMedCrossRefGoogle Scholar
  49. Shoemaker D, Burke G, Dorr A, Temple R, Friedman MA (1990) A regulatory perspective. In: Spilker B (ed) Quality of life assessment in clinical trials. New York, Raven Press, pp 193–201Google Scholar
  50. Southwest Oncology Group. Report of Studies (1993) Seattle, WA, Southwest Oncology Group Statistical Center, pp 5, 7Google Scholar
  51. Spilker B (ed) (1990) Quality of life assessments in clinical trials. New York, Raven PressGoogle Scholar
  52. Sprangers MAG, Aaronson NK (1992) The role of health care providers and significant others in evaluating the quality of life of patients with chronic disease: A review. J Clin Epidemiol 45: 743–760PubMedCrossRefGoogle Scholar
  53. Stewart AL, Hays RD, Ware JE Jr (1988) The MDS Short-form General Health Survey. Reliability and validity in a patient population. Med Care 26: 724–735PubMedCrossRefGoogle Scholar
  54. Stewart AL, Greenfield S, Hays RD, Wells K, Rogers WH, Berry DS, McGlynn EA, Ware JE Jr (1989) Functional status and well-being of patients with chronic conditions. Results from The Medical Outcomes Study. JAMA 262: 907–913PubMedCrossRefGoogle Scholar
  55. Stewart DW, Shamdasani PN (1990) Focus Groups. Theory and Practice. Applied Social Research Methods Series. Vol. 20. Newbury Park, CA, Sage PublicationsGoogle Scholar
  56. Stewart AL, Ware JE Jr (eds) (1992) Measuring functioning and well-being. The Medical Outcomes study approach. Durham and London, Duke University PressGoogle Scholar
  57. Tchekmedyian NS, Cella DF (eds) (1991) Quality of life in oncology practice and research. Williston Park, NJ, Dominus Pub.Google Scholar
  58. Trevino FM, Moyer E, Valdez RB, Stroup-Benham CA (1991) Health insurance coverage and utilization of health services by Mexican Americans, mainland Puerto Ricans, and Cuban Americans. JAMA 265: 233–237PubMedCrossRefGoogle Scholar
  59. U.S. Department of Health and Human services. Health Resources Administration. Bureau of Health Professions. Division of Disadvantaged Assistance (1985). Health Status of minorities and low income groups. DHHS Publication No. (HRSA) HRS-P-DV85-1. Washington, D.C., U.S. Government Printing OfficeGoogle Scholar
  60. Walker SN, Kerr MJ, Pender NJ, Sechrist KR (1990) A Spanish language version of the health-promoting lifestyle profile. Nursing Res 39: 268–273Google Scholar
  61. Ware JE Jr, Sherbourne CD (1992) The MOS 36-item Short-Form Health Survey (SF-36).I. Conceptual framework and item selection. Med Care 30: 473–483PubMedCrossRefGoogle Scholar
  62. Westberg J (1989) Patient education for Hispanic Americans. Patient Educ Counseling 13: 143–160CrossRefGoogle Scholar
  63. World Health Organization (1958) The first ten years of the World Health Organization. Geneva, World Health Organization, Annex 1, (Constitution of the World Health Organization), p 459Google Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 1994

Authors and Affiliations

  • C. M. Moinpour

There are no affiliations available

Personalised recommendations