Innovative Research Methods: Prevention and Management of Symptoms in Chronic Illness (R01)

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This funding opportunity seeks to update the randomized control trial (RCT) design using novel research methods that are practical, innovative, and hold promise for producing more effective outcomes. Novel clinical research designs, applied to symptom management trials, may identify those treatment strategies that best alter the course of symptom burden in chronic illness by addressing the issues of varied treatment responses across patients, subject retention, and adherence to treatment regimens. For example, sequential multiple assignment randomization trials (SMART) design have been used successfully to develop dynamic treatment regimens for alcohol, depression and HIV infection but are not widely used in symptom management trials. The approach is pragmatic in that it mimics clinical practice by allowing a re-evaluation of treatment options based on an individuals progress towards treatment goals. The levels or inclusion of intervention components are tailored in response to individual characteristics or progress toward a treatment goal. Subjects may be randomly assigned several times to varying amounts and types of intervention components based on predetermined decision rules.

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