Profile of men randomized to the prostate cancer prevention trial: Baseline health-related quality of life, urinary and sexual functioning, and health behaviors

Journal of Clinical Oncology

Volumn 18, Issue 9, 2000, Pages 1942-1953

  Moinpour, Carol M ^a   Lovato, Laura C ^a   Thompson Jr , Ian M ^a   Ware Jr , John E ^a   Ganz, Patricia A ^a   Patrick, Donald L ^a   Shumaker, Sally A ^a   Donaldson, Gary W ^a   Ryan, Anne ^a   Coltman Jr , Charles A ^a  

^a TUFTS MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FINASTERIDE; PLACEBO;

ADULT; AGED; ARTICLE; CANCER PREVENTION; CAUCASIAN; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEPRESSION; DIABETES MELLITUS; DISEASE ASSOCIATION; DOUBLE BLIND PROCEDURE; HEALTH BEHAVIOR; HEALTH SURVEY; HUMAN; HYPERTENSION; LIFESTYLE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; PROSTATE CANCER; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SEXUAL DYSFUNCTION; SEXUAL FUNCTION; SMOKING; SOCIAL STATUS; TREATMENT OUTCOME; UNITED STATES; URINARY TRACT FUNCTION;

EID: 0034015673     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2000.18.9.1942     Document Type: Article

References (58)

1. Thompson IM, Coltman CA: Screening for prostate cancer: Opportunities for prevention. Semin Urol Oncol 14:4-11, 1996
2. Brawley OW, Ford LG, Thompson IM: 5-Alpha-reductase inhibition and prostate cancer prevention. Cancer Epidemiol Biomarkers Prev 86:177-182, 1994
3. Gormley GJ, Brawley O, Thompson IM: The potential application of finasteride for chemoprevention of prostate cancer. Ann N Y Acad Sci 768:163-169, 1995
4. Thompson I, Feigl P, Coltman C: Chemoprevention of prostate cancer with finasteride, in DeVita VT, Hellman S, Rosenberg J (eds): Important Advances in Oncology. Philadelphia, PA, Lippincott, 1995, pp 57-76
5. Patrick DL, Erickson P: Assessing health-related quality of life for clinical decision-making, in Walker S, Rosser R (eds): Quality of Life Assessment: Key Issues in the 1990s. Dordrecht, the Netherlands, Kluwer Academic, 1993, pp 11-64
6. Guyatt GH, Feeny DH, Patrick DL: Measuring health-related quality of life. Ann Intern Med 118:622-629, 1993
7. World Health Organization: The First Ten Years of the World Health Organization. Geneva, Switzerland, World Health Organization, 1958
8. Wenger NK, Mattson M, Furberg C, et al: Assessment of quality of life in clinical trials of cardiovascular therapies. New York, NY, Le Jacq Publishing Company, 1984
9. Schron EB, Shumaker SA: The integration of health quality of life in clinical research: Experiences from cardiovascular clinical trials. Prog Cardiovasc Nurs 7:21-28, 1992
10. Gorkin L, Norvell NK, Rosen RC, et al: Assessment of quality of life as observed from the baseline data of the Studies of Left Ventricular Dysfunction (SOLVD) trial quality-of-life substudy. Am J Cardiol 71:1069-1073, 1993
11. Rogers WJ, Johnstone DE, Yusuf S, et al: Quality of life among 5,025 patients with left ventricular dysfunction randomized between placebo and enalapril: The studies of left ventricular dysfunction. J Am Coll Cardiol 23:393-400, 1994
12. Wenger NK: Cardiovascular disorders, in Spilker B (ed): Quality of Life and Pharmacoeconomics in Clinical Trials (ed 2). Philadelphia, PA, Lippincott-Raven, 1996, pp 883-889
13. Wiklund I, Dimenä SE, Wahl M: Factors of importance when evaluating quality of life in clinical trials. Control Clin Trials 11:169-179, 1990
14. Fox NL, Czajkowski S, Dupuis GH, et al: Quality of life in POST CABG patients. Circulation 96:1-341, 1997 (abstr)
15. Moinpour CM, Feigl P, Metch B, et al: Quality of life end points in cancer clinical trials: Review and recommendations. J Natl Cancer Inst 81:485-495, 1989
16. Nayfield SG, Ganz PA, Moinpour CM, 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
17. Osoba D: Lessons learned from measuring health-related quality of life in oncology. J Clin Oncol 12:608-616, 1994
18. Varricchio CG, McCabe MS, Trimble E, et al. Quality of life in clinical cancer trials: Introduction. J Natl Cancer Inst Monogr 20:vii-viii, 1996
19. Nayfield SG: Roles of government agencies in support and application of quality of life research, in Spilker B (ed): Quality of Life and Pharmacoeconomics in Clinical Trials (ed 2). Philadelphia, PA, Lippincott-Raven, 1996, pp 779-783
20. The Writing Group for the PEPI Trial: Effects of estrogen or estrogen/progestin regimens on heart disease risk factors in postmenopausal women. JAMA 273:199-208, 1995
21. Espeland MA, Bush TL, Mebane-Sims I, et al: Rationale, design, and conduct of the PEPI trial. Control Clin Trials 16.1S-19S, 1995
22. Miller VT, Byington RL, Espeland MA, et al. Baseline characteristics of the PEPI participants. Control Clin Trials 16:54S-72S, 1995
23. Ganz PA, Day R, Ware JE Jr, et al. Base-line quality-of-life assessment in the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial. J Natl Cancer Inst 87:1372-1382, 1995
24. Day R, Ganz PA, Costantino JP, et al: Health-related quality of life and tamoxifen in breast cancer prevention: A report from the National Surgical Adjuvant Breast and Bowel Project P-1 study. J Clin Oncol 17:2659-2669, 1999
25. Matthews KA, Shumaker SA, Bowen DJ, et al: Women's health initiative: Why now? What is it? What's new? Am Psychol 52:101-116, 1997
26. Wilt TJ, Brawer MK: The Prostate Cancer Intervention Versus Observation Trial: A randomized trial comparing radical prostatectomy versus expectant management for the treatment of clinically localized prostate cancer. J Urol 152:1910-1914, 1994
27. Hartman TJ, Albanes D, Rautalahti M, et al: Physical activity and prostate cancer in the Alpha-Tocopherol, Beta-Carotene (ATBC) Cancer Prevention Trial (Finland). Cancer Causes Control 9:11-18, 1998
28. Ware JE Jr, Kosinski M, Keller SD: SF-36 Physical and Mental Health Summary Scales: A User's Manual. Boston, MA, The Health Institute, New England Medical Center, 1994
29. Cigarette smoking among adults: United States, 1995. MMWR Morb Mortal Wkly Rep 46:1217-1220, 1997
30. Grant BF, Peterson A, Dawson DA, et al: Source and Accuracy Statement for the National Longitudinal Alcohol Epidemiologic Survey: Wave 1. Rockville, MD, National Institute on Alcohol Abuse and Alcoholism, 1994
31. Block G, Clifford C, Naughton MD, et al. A brief dietary screen for high fat intake. J Nutr Educ 21:199-207, 1989
32. Stewart AL, Hays RD, Wells KB, et al. Development of Measures of Physical Activity/Exercise and Tests of Variations in Physical Activity Levels Within Chronic Disease Groups in the Medical Outcomes Study (report no. P-7781). Santa Monica, CA, RAND Corporation, 1993
33. Stewart AL, Hays RD, Wells KB, et al: Long-term functioning and well-being outcomes associated with physical activity and exercise in patients with chronic conditions in the medical outcomes study. J Clin Epidemiol 47:719-730, 1994
34. Barry MJ, Fowler F Jr, O'Leary MP, et al: The American Urological Association Symptom Index for benign prostatic hyperplasia. J Urol 148:1549-1557, 1992
35. Barry MJ, Fowler FJ Jr, O'Leary MP, et al: Measuring disease-specific health status in men with benign prostatic hyperplasia. Med Care 33:AS145-AS155, 1995
36. Sherbourne CD: Social functioning: Sexual problems measures, in Stewart AL, Ware JE Jr (eds): Measuring Functioning and Well-Being: The Medical Outcomes Study Approach. Durham, NC, Duke University Press, 1992, pp 194-204
37. Epstein RS, Deverka PA, Chute CG, et al: Validation of new quality of life questionnaire for benign prostatic hyperplasia. J Clin Epidemiol 45:1431-1445, 1992
38. Ware JE Jr, Sherbourne CD: The MOS 36-item Short-Form Health Survey (SF-36): 1. Conceptual framework and item selection. Med Care 30:473-483, 1992
39. McHorney C, Ware JE Jr, Raczek A: The MOS 36-item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care 31:247-263, 1993
40. Ware JE Jr, Snow KK, Kosinski MA, et al: SF-36 Health Survey: Manual and Interpretation Guide. Boston, MA, Nimrod Press, 1993
41. McHorney CA, Ware JE Jr, Lu RJF, et al: The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care 32:40-46, 1994
42. Ware JE Jr: The SF-36 Health Survey, in Spilker B (ed): Quality of Life and Pharmacoeconomics in Clinical Trials (ed 2). Philadelphia, PA, Lippincott-Raven, 1996, pp 337-345
43. Cronbach LJ: Coefficient alpha and the internal structure of tests. Psychometrika 16:297-334, 1951
44. Cohen J: Statistical power analysis for the behavioral sciences. Hillsdale, NJ, Lawrence Erlbaum Associates, 1988
45. SAS Institute Inc. SAS/STAT Software, Release 6:12. Cary, NC, SAS Institute, 1996
46. Nunnally J: Psychometric Theory. New York, NY, McGraw-Hill, 1978
47. Feldman HA, Goldstein I, Hatzichristou DG, et al: Impotence and its medical and psychosocial correlates: Results of the Massachusetts Male Aging Study. J Urol 151:54-61, 1994
48. Lipid Metabolism Branch, Division of Heart and Vascular Diseases, National Heart, Lung and Blood Institute, Department of Health and Human Services, US Public Health Service, National Institutes of Health: The Lipid Research Clinics Population Studies Data Book, Vol 1: The Prevalence Study - Aggregate Distributions of Lipids, Lipoproteins and Selected Variables in 11 North American Populations (NIH publication 80-1527). Washington, DC, United States Government Printing Office, 1980, pp 52, 76
49. Roberts WC: Preventing and arresting coronary atherosclerosis: Poor implementation of risk factor interventions. Am Heart J 130:580-600, 1995
50. Barry MJ: Epidemiology and natural history of benign prostatic hyperplasia. Urol Clin North Am 17:495-507, 1990
51. Guess HA: Benign prostatic hyperplasia: Antecedents and natural history. Epidemiol Rev 14:131-153, 1992
52. Gormley GJ, Stoner E, Bruskewithz RC, et al: The effect of finasteride in men with benign prostatic hyperplasia. N Engl J Med 327:1185-1191, 1992
53. Stoner E, Members of the Finasteride Study Group: Three-year safety and efficacy data on the use of finasteride in the treatment of benign prostatic hyperplasia. Urology 43:284-294, 1994
54. Drugs that cause sexual dysfunction: An update (review). Med Lett Drugs Ther 34:73-78, 1992
55. Coltman CA Jr, Thompson IM Jr, Feigl P: Prostate Cancer Prevention Trial (PCPT) update. Eur Urol 35:544-547, 1999
56. Wagner TH, Patrick DL, McKenna SP: Cross-cultural development of a quality of life measure for men with erection difficulties. Qual Life Res 5:443-449, 1996
57. Litwin MS, Nied RJ, Dhanani N: Health-related quality of life in men with erectile dysfunction. J Gen Intern Med 13:159-166, 1998
58. Moinpour CM, Atkinson J, Hill MS, et al: Prostate Cancer Prevention Trial Minority Recruitment Manual. Seattle, WA, Southwest Oncology Group Statistical Center, 1996