Abstract
The purpose of this study is to improve the management of symptoms in patients with cancer who are undergoing chemotherapy. Patients are monitored for up to 8 consecutive weeks to determine their reported level of severity on each of 7 prevalent symptoms. When symptom severity reaches a 2 or higher {on a 10 point scale), then that patient is enrolled into the symptom management trial, receives a baseline interview and is then randomized to either a multi-modal Patient Assisted Management of Symptoms (PAMS) intervention individualized for patients or to a Telephone Information and Monitoring of Symptoms (TIMS) approach (enhanced usual care). Both arms of the trial receive printed material, a Symptom Management Toolkit (SMT). Patients in the PAMS arm will receive 8 weekly calls from a specially trained nurse who will assess all 7 symptoms at each contact, individualize 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 Symptom Management Toolkit (SMT) for assistance with managing each symptom and will be reminded to call their oncology clinic if symptoms are urgent. At weeks 9 and 15 patients will receive outcome interviews. Following the 15-week interview patients' medical records will be audited, and costs and charge data collected. Outcomes at 9 and 15 weeks include; significant reduction in symptom severity and improvement in health states. This proposed application seeks to determine if a nurse delivered intervention individualized to patients' needs for symptom management delivered entirely by telephone and involving a symptom management toolkit results in a significant reduction in symptom severity compared to when symptoms are monitored by telephone with reference to the symptom management toolkit. This research controls for the method of delivering the intervention (telephone), the intensity (8 contacts), and the use of printed material (symptom management toolkit) and seeks to determine the value added b a nurse delivered intervention referral to a symptom management toolkit alone. To test this intervention 350 patients will be accrued, a 30% dropout rate is expected with 122 patients surviving through the 15-week observation. Special recruitment strategies are presented for accruing and retaining women and minorities. Analysis strategies are presented to address reduction in severity among the 7 target symptoms, the primary outcome, as well as secondary outcome. Strategies for collection, exploratory analysis, and comparison of utilization and costs between the two arms are presented.
|
|
Principal Investigator
Charles Given
Co-Investigator
Ruth McCorkle
|
|
|
