To improve the management of symptoms, patients with cancer undergoing chemotherapy are monitored using an automated telephone system to record the severity of seven prevalent symptoms for eight consecutive weeks. When symptom severity reaches two or higher (on a 11 point scale), for one or more symptoms that patient is enrolled into a trial, receives a baseline interview, and is randomized to either an individualized multimodal Patient Assisted Management of Symptoms (PAMS) intervention or to a Telephone Information and Monitoring of Symptoms (TIMS) approach (i.e., enhanced usual care). Both arms of the trial receive a Symptom Management Toolkit (SMT). Patients in the PAMS arm receive 8 weekly calls from a specially trained nurse who will assess all seven symptoms at each contact, and provide individualized interventions using a problem solving approach guided by a computer assisted protocol. Patients in the TIMS arm will receive 8 weekly-automated telephone calls with instructions to refer to specific pages of the SMT and are reminded to call their oncology clinic if symptoms are urgent. At weeks 9 and 15, patients will receive outcome interviews. Following the week 15 interview, patients' medical records will be audited; treatment, cost and charge data collected. Outcomes include: significant reduction in symptom severity and improvement in health states. This research study controls for the method of delivering the intervention (telephone), the intensity (8 weekly contacts), and the use of printed materials in the toolkit (SMT) and seeks to determine the value added by a patient-assisted intervention individualized to meet patients' needs for symptom management (PAMS) plus a SMT when contrasted with symptom monitoring by telephone (TIMS) and referral to a SMT alone. For this study, 350 patients will be accrued. A 30% drop out rate is expected with 122 patients surviving through the 15-week observation in each arm. Special recruitment strategies are presented for accruing and retaining women and minorities. Analysis strategies address reduction among the seven targeted symptoms, the primary outcome, as well as secondary outcomes. Strategies for collection, exploratory analysis, and comparison of utilization and costs between the two arms are presented.
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