Funding patient-reported outcomes in cancer clinical trials

Journal of Clinical Oncology

Volumn 25, Issue 32, 2007, Pages 5100-5105

  Moinpour, Carol M ^a   Denicoff, Andrea M ^a   Bruner, Deborah Watkins ^a   Kornblith, Alice B ^a   Land, Stephanie R ^a   O'Mara, Ann ^a   Trimble, Edward ^a  

^a SOUTHWEST ONCOLOGY GROUP STATISTICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CANCER THERAPY; CLINICAL TRIAL; CONFERENCE PAPER; FUNDING; HEALTH SERVICE; HEALTH SURVEY; HUMAN; MEDICAL LITERATURE; NEOPLASM; PRIORITY JOURNAL; REIMBURSEMENT;

CLINICAL TRIALS AS TOPIC; HUMANS; NEOPLASMS; PATIENT SATISFACTION; QUALITY INDICATORS, HEALTH CARE; QUALITY OF LIFE; RESEARCH SUPPORT AS TOPIC; SICKNESS IMPACT PROFILE; TREATMENT OUTCOME;

EID: 36849061047     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2007.11.5329     Document Type: Conference Paper

References (32)

1. McCorkle R, Young K: Development of a symptom distress scale. Cancer Nurs 1:373-378, 1978
2. Spitzer WO, Dobson AJ, Hall J, et al: Measuring the quality of life of cancer patients: A concise QL-Index for use by physicians. J Chron Dis 34:585-597, 1981
3. Sugarbaker PH, Barofsky I, Rosenberg SA, et al: Quality of life assessment of patients in extremity sarcoma clinical trials. Surgery 91:17-23, 1982
4. Daut RL, Cleeland CS, Flannery R: Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain 17:197-210, 1983
5. Schipper H, Clinch J, McMurray A, et al: Measuring the quality of life of cancer patients: The Functional Living Index-Cancer - Development and validation. J Clin Oncol 2:472-483, 1984
6. Ferrans CE, Powers MJ: Quality of life index: Development and psychometric properties. ANS 8:15-24, 1985
7. Johnson JR, Temple R: Food and Drug Administration requirements for approval of new anticancer drugs. Cancer Treat Rep 69:1155-1159, 1985
8. de Haes JC, van Knippenberg FC: The quality of life of cancer patients: A review of literature. Soc Sci Med 20:809-817, 1985
9. Cella DF, Jacobsen PB, Orav EJ, et al: A brief POMS measure of distress for cancer patients. J Chronic Dis 40:939-942, 1987
10. Aaronson NK, Bullinger M, Ahmedzai S: A modular approach to quality-of-life assessment in cancer clinical trials. Recent Results Cancer Res 111:231-249, 1988
11. Ganz PA, Haskell CM, Figlin RA, et al: 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 61:849-856, 1988
12. Levine MN, Guyatt GH, Gent M, et al: Quality of life in stage II breast cancer: An instrument for clinical trials. J Clin Oncol 6:1798-1810, 1988
13. Maguire P, Selby P: Assessing the quality of life in cancer patients. Br J Cancer 60:437-440, 1989
14. 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
15. Donovan K, Sanson-Fisher RW, Redman S: Measuring quality of life in cancer patients. J Clin Oncol 7:959-968, 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. Furberg CD, Schuttinga JA: Quality of life assessment: Practice, problems, and promise, in Furberg C, Schuttinga JA (eds): NIH-sponsored Workshop on Quality of Life Assessment. Bethesda, MD, US Department of Health and Human Services, Public Health Service, National Institutes of Health, 1993, pp 1-90
18. Varricchio CG, McCabe MS, Trimble E, et al: Introduction: Quality of life in clinical cancer trials. Proceedings of a workshop held at the National Institutes of Health, Bethesda, MD, March 1-2, 1995. J Natl Cancer Inst Monogr 20, 1996, pp vii-viii
19. Lipscomb J, Gotay C, Snyder C: Outcomes Assessment in Cancer: Measures, Methods, and Applications. Cambridge, United Kingdom, Cambridge University Press, 2005
20. Patrick D, Erickson P: What constitutes quality of life? Concepts and dimensions. Clin Nutr 7:53-63, 1988
21. US Food and Drug Administration: Guidance for Industry: Patient-reported outcome measures - Use in medical product development to support labeling claims. http://www.fda.gov/cder/guidance/5460dft.pdf
22. Moinpour CM: Costs of quality-of-life research in Southwest Oncology Group trials. J Natl Cancer Institute Monogr 20:11-16, 1996
23. Watkins Bruner D, Bryan CJ, Aaronson N, et al: Issues and challenges with integrating patient-reported outcomes in clinical trials supported by NCI-sponsored clinical trials networks. J Clin Oncol 25:5051-5057, 2007
24. National Cancer Institute: Cancer Therapy Evaluation Program: Guidelines and tools for protocol development. http://ctep.cancer.gov/guidelines/
25. Emanuel EJ, Schnipper LE, Kamin DY, et al: The costs of conducting clinical research. J Clin Oncol 21:4145-4150, 2003
26. Roche K, Paul N, Smuck B, et al: Factors affecting workload of cancer clinical trials: Results of a multicenter study of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 20:545-556, 2002
27. Reference deleted.
28. Kornblith AB, Holland JC: Model for quality-of-life research from the Cancer and Leukemia Group B: The telephone interview, conceptual approach to measurement, and theoretical framework. J Natl Cancer Inst Monogr 20:55-62, 1996
29. Reeve BB: Special issues for building computerized-adaptive tests for measuring patient-reported outcomes: The NIH's investment in new technology. Med Care 44:S198-S204, 2006
30. Lipscomb J, Reeve B, Clauser S, et al: Patient-Reported Outcomes assessment in cancer trials: Taking stock, moving forward. J Clin Oncol 25:5133-5140, 2007
31. Ganz PA, Gotay CC. The use of Patient-Reported Outcomes in Phase III Cancer Treatment Trials: Lessons learned and future directions. J Clin Oncol 25:5063-5069, 2007
32. Sloan, JA, Berk L, Roscoe J, et al: Integrating Patient-Reported Outcomes into cancer symptom management clinical trials supported by the NCI-sponsored Clinical Trials Networks. J Clin Oncol 25:5070-5077, 2007