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25 - Bayesian adaptive design: a novel approach to test the effectiveness of symptom-reducing agents using patient-reported outcomes
- from Section 4 - Symptom Measurement
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- By Valen E. Johnson, The University of Texas M. D. Anderson Cancer Center, Tito R. Mendoza, The University of Texas M. D. Anderson Cancer Center
- Edited by Charles S. Cleeland, University of Texas, M. D. Anderson Cancer Center, Michael J. Fisch, University of Texas, M. D. Anderson Cancer Center, Adrian J. Dunn, University of Hawaii, Manoa
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- Book:
- Cancer Symptom Science
- Published online:
- 05 August 2011
- Print publication:
- 18 November 2010, pp 293-303
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- Chapter
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Summary
Better symptom management, in cancer as well as in other diseases, has been hampered by the lack of a strong clinical-trial evidence base for guiding symptom management practice. The 2001 Institute of Medicine report Improving Palliative Care for Cancer reviewed the paucity of clinical research that might present a basis for evidence-based symptom management. A 2003 NIH State of the Science review concluded that symptoms, especially pain, fatigue, and depression, were undermanaged in cancer care and recommended an increased effort to develop evidence that would support the rational use of both biological and behavioral interventions for symptom management.
Various barriers have hindered the development of evidence-based methods for controlling treatment-related symptom burden, despite the availability of adequate symptom measurement methods. For example, the control of treatment-related symptoms almost always involves the use of combined treatment modalities, which are difficult to evaluate using traditional randomized clinical trial methods, where single symptoms are typically managed with single agents (eg, pain controlled with a single analgesic). When clinicians do treat multiple symptoms, they are likely to prescribe multiple agents based on anecdotal experience or the patient's perceived needs, rather than on evidence-based research. Further, many of the agents that might be effective in the control of treatment-related symptom burden are generic or off-patent drugs that will never receive clinical research support from the pharmaceutical industry because there is no financial incentive to support clinical trials testing their effectiveness for symptom control.
23 - Symptom measurement by patient report
- from Section 4 - Symptom Measurement
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- By Charles S. Cleeland, The University of Texas M. D. Anderson Cancer Center, Tito R. Mendoza, The University of Texas M. D. Anderson Cancer Center
- Edited by Charles S. Cleeland, University of Texas, M. D. Anderson Cancer Center, Michael J. Fisch, University of Texas, M. D. Anderson Cancer Center, Adrian J. Dunn, University of Hawaii, Manoa
-
- Book:
- Cancer Symptom Science
- Published online:
- 05 August 2011
- Print publication:
- 18 November 2010, pp 268-284
-
- Chapter
- Export citation
-
Summary
The symptoms of both cancer and cancer treatment (eg, pain, fatigue, poor appetite, sleep disturbance, and cognitive impairment), like the symptoms of other chronic diseases, can significantly impair a patient's quality of life, comfort, and ability to function. The inability to tolerate treatment-related symptoms often preempts full and effective treatment, and residual symptoms of treatment may limit the functioning of those who are otherwise cured of the disease.
Reducing the severity and impact of symptoms is naturally an endpoint for clinical trials that include symptom-focused interventions. In contrast, symptom management during clinic visits requires planning that is based on the clinician's having the best possible information about the patient's symptom status. Because clinicians and patients commonly face choices among treatments that are similarly effective for tumor control and prolonging survival, differences in the patient's symptoms during the survival period have become critical variables in making individualized treatment choices and in developing new therapies. Thus, having the ability to compare treatment-related symptoms provides an additional benchmark for appraising various cancer treatments. Policy planning and quality assurance also depend on information about the extent and severity of symptoms. All of these objectives require symptom measurement, the focus of this chapter.
Although symptoms are based on complex biological and behavioral phenomena, as subjective experiences their measurement is typically restricted to self-report. This chapter presents a status report on characterizing and measuring cancer-related symptoms by asking the patient about them using single items, single-symptom multi-item measures, and multisymptom questionnaires.