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Grant Abstract Automated Telephone
Monitoring for Symptom Management
To improve the management of symptoms, patients with cancer undergoing
chemotherapy are monitored using an automated telephone system to record
the severity of 7 prevalent symptoms for up to 8 consecutive weeks.
When symptom severity reaches a 2 or higher (10 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 multi-modal
Patient Assisted Management of Symptoms (PAMS) intervention or to a
Telephone Information and Monitoring of Symptoms (TIMS) approach (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 7 symptoms at each contact, 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 week15 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 controls for the method of delivering the intervention (telephone),
the intensity (8 weekly contacts), and the use of printed material in
the toolkit (SMT) and seeks to determine the value added by a patient-assisted
intervention individualized to patients’ needs for symptom management
(PAMS) plus an SMT when contrasted with symptom monitoring by telephone
(TIMS) and referral to an SMT alone. For this test, 350 patients will
be accrued. A 30% dropout 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 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. |
