Impact of quality of life on patient expectations regarding phase I clinical trials

Journal of Clinical Oncology

Volumn 18, Issue 2, 2000, Pages 421-428

  Cheng, Jonathan D ^a   Hitt, James ^a   Koczwara, Bogda ^a   Schulman, Kevin A ^a   Burnett, Caroline B ^a   Gaskin, Darrell J ^a   Rowland, Julia H ^a   Meropol, Neal J ^a  

^a GEORGETOWN UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT;

ADULT; AGED; ARTICLE; CANCER CHEMOTHERAPY; CANCER PATIENT; CLINICAL ARTICLE; CLINICAL TRIAL; DECISION MAKING; DRUG EFFECT; EXPECTATION; FEMALE; HUMAN; MALE; NURSE; PERCEPTION; PHASE 1 CLINICAL TRIAL; PHYSICIAN; PRIORITY JOURNAL; QUALITY OF LIFE; TOXICITY;

EID: 0033971036     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/jco.2000.18.2.421     Document Type: Article

References (45)

1. McNeil BJ, Pauker SG, Sox HC, et al: On the elicitation of preferences for alternative therapies. N Engl J Med 306:1259-1262, 1982
2. O'Connor AM: Effects of framing and level of probability on patients' preferences for cancer chemotherapy. J Clin Epidemiol 42:119-126, 1989
3. Yabroff KR, Rubenstein LE, Gold KF, et al: Information framing in physician description of treatment options for cancer patients. Med Decis Making 15:432a, 1995 (abstr)
4. Penman DT, Holland JC, Bahna GF, et al: Informed consent for investigational chemotherapy: Patients' and physicians' perceptions. J Clin Oncol 2:849-855, 1984
5. Daugherty C, Ratain MJ, Grochowski E, et al: Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 13:1062-1072, 1995
6. Sutherland HJ, Llewellyn-Thomas HA, Lockwood GA, et al: Cancer patients: Their desire for information and participation in treatment decisions. J R Soc Med 82:260-263, 1989
7. Cassidy J, Macfarlane DK: The role of the nurse in clinical cancer research. Cancer Nurs 14:124-131, 1991
8. Engelking C: Facilitating clinical trials: The expanding role of the nurse. Cancer 67:1793-1797, 1991
9. Hazelton J: The role of the nurse in phase I clinical trials. J Pediatr Oncol Nurs 8:43-45, 1991
10. Koczwara B, Pixley L, Meropol NJ: The nursing perspective on clinical research at a comprehensive cancer center. Proc Am Soc Clin Oncol 16:417a, 1997 (abstr 1491)
11. Nealon E, Blumberg B, Brown B: What do patients know about clinical trials? Am J Nurs 85:807-810, 1985
12. Weeks JC, Cook EF, O'Day SJ, et al: Relationship between cancer patients' predictions of prognosis and their treatment preferences. JAMA 279:1709-1714, 1998
13. Yellen SB, Cella DF, Leslie WT: Age and clinical decision making in oncology patients. J Natl Cancer Inst 86:1776-1770, 1994
14. Mackillop WJ, Stewart WE, Ginsburg AD, et al: Cancer patients' perceptions of their disease and its treatment. Br J Cancer 58:355-358, 1988
15. Yellen SB, Cella DF: Someone to live for: Social well-being, parenthood status, and decision-making in oncology. J Clin Oncol 13:1255-1264, 1995
16. Rodenhuis S, van den Heuvel WJ, Annyas AA, et al: Patient motivation and informed consent in a phase I study of an anticancer agent. Eur J Cancer Clin Oncol 20:457-462, 1984
17. Yoder LH, O'Rourke TJ, Etnyre A, et al: Expectations and experiences of patients with cancer participating in phase I clinical trials. Cancer Prev 24:891-896, 1997
18. National Institutes of Health, Office of the Director: Quality of Life Assessment: Practice, Problems, and Promise - Proceedings of a Workshop, October 15-17, 1990. Bethesda, MD, U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, 1993, pp 47-49
19. Burris HA III: Objective outcome measures of quality of life. Oncology 10:131-135, 1996
20. Tannock IF, Osoba D, Stockler MR, et al: Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: A Canadian trial with palliative end points. J Clin Oncol 14:1756-1764, 1996
21. Cella DF, Bonomi AE: Measuring quality of life: 1995 Update. Oncology 9:47-60, 1995
22. Ganz PA: Quality of life measures in cancer chemotherapy: Methodology and implications. Pharmacoeconomics 5:376-388, 1994
23. Coates A, Gebski V, Bishop JF, et al: Improving the quality of life during chemotherapy for advanced breast cancer. N Engl J Med 317:1490-1495, 1987
24. Ganz PA, Schag CAC, Lee JJ, et al: Breast conservation versus mastectomy: Is there a difference in psychological adjustment or quality of life in the year after surgery? Cancer 69:1729-1738, 1992
25. Fowler FJ Jr, Wennberg JE, Timothy RP, et al: Symptom status and quality of life following prostatectomy. JAMA 259:3018-3022, 1988
26. Croog SH, Levine S, Testa MA, et al: The effects of antihypertensive therapy on the quality of life. N Engl J Med 314:1657-1664, 1986
27. McClellan WM, Anson C, Birkeli K, et al: Functional status and quality of life: Predictors of early mortality among patients entering treatment for end stage renal disease. J Clin Epidemiol 44:83-89, 1991
28. Ganz PA, Lee JJ, Siau J: Quality of life assessment: An independent prognostic variable for survival in lung cancer. Cancer 67:3131-3135, 1991
29. Melink TJ, Von Hoff DD, Clark GM, et al: Impact of phase I clinical trials on the quality of life and survival of cancer patients. Proc Am Soc Clin Oncol 4:251a, 1985 (abstr C-980)
30. Gaskin DJ, Kong J, Meropol NJ, et al: Treatment choices by seriously ill patients: The health stock risk adjustment model. Med Decis Making 18:84-94, 1998
31. Cella DF, Tulsky DS, Gray G, et al: The Functional Assessment of Cancer Therapy scale: Development and validation of the generalmeasure. J Clin Oncol 11:570-579, 1993
32. Ware JE Jr, Sherbourne CD: The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Med Care 30:473-483, 1992
33. Schag CA, Heinrich RL: Development of a comprehensive quality of life measurement tool: CARES. Oncology 4:135-138, 1990
34. Smith TL, Lee JJ, Kantarjian HM, et al: Design and results of phase I cancer clinical trials: Three-year experience at MD Anderson Cancer Center. J Clin Oncol 14:287-295, 1996
35. Estey E, Hoth D, Simon R, et al: Therapeutic response in phase I trials of antineoplastic agents. Cancer Treat Rep 70:1105-1115, 1986
36. Decoster G, Stein G, Holdner EE: Responses and toxic deaths in phase I clinical trials. Ann Oncol 1:175-181, 1990
37. Penta JS, Rosner GL, Trump DL: Choice of starting dose and escalation for phase I studies of antitumor agents. Cancer Chemother Pharmacol 31:247-250, 1992
38. Siminoff LA, Fetting JH, Abeloff MD: Doctor-patient communication about breast cancer adjuvant therapy. J Clin Oncol 7:1192-1200, 1989
39. Daugherty C, Lyman K, Mick R, et al: Differences in perception of goals, expectations and level of informed consent between oncologists (ones) and patients (pts) involved in phase I clinical trials. Proc Am Soc Clin Oncol 15:530a, 1996 (abstr 1713)
40. Fowler FJ Jr, Cleary PD, Massagli MP, et al: The role of reluctance to give up life in the measurement of the values of health states. Med Decis Making 15:195-200, 1995
41. Daugherty CK: Empirical research on the ethics of informed consent and phase I cancer trials. Forum Trends Exp Clin Med 7:266-274, 1997
42. Osoba D, Zee B: Completion rates in health-related quality-of-life assessment: Approach of the National Cancer Institute of Canada clinical trial group. Stat Med 17:603-612, 1998
43. Ganz PA, Day R, Costantino J: Compliance with quality of life data collection in the National Surgical Adjuvant Breast and Bowel Project (NSABP) breast cancer prevention trial. Stat Med 17:613-622, 1998
44. Hahn EA, Webster KA, Cella DF, et al: Missing data in quality of life research in Eastern Cooperative Oncology Group (ECOG) clinical trials: Problems and solutions. Stat Med 17:547-559, 1998
45. Bernhard J, Cella DF, Coates AS, et al: Missing quality of life data in cancer clinical trials: Serious problems and challenges. Stat Med 17:517-532, 1998