Improving the management of chemotherapy toxicities in haematological cancer patients:a phase II randomised controlled trial of the Patient Remote Intervention and Symptom Management System (PRISMS)

Background: Patients with haematological malignancies are at increased risk of serious/life-threatening chemotherapy toxicities. We have previously developed a highly acceptable system to remotely monitor/manage chemotherapy toxicities of haematological cancer patients in the community setting. This phase II trial combines the remote monitoring system with a novel nurse-led intervention (PRISMS).Aims: To pilot the intervention to: estimate potential effect sizes/coefficients of variation to form the basis of power calculations; calculate patient recruitment/retention rates; assess intervention compliance rates.Methods/Design: Thirty patients are being recruited from two Melbourne hospitals. Eligibility criteria include: diagnosis of Chronic Lymphocytic leukaemia/Hodgkin’s/Non-Hodgkin’s lymphoma; aged ?18 years. Patients are randomized 1:1 to either the control or intervention arm. Patients allocated to the control arm receive ‘Usual Care’ whilst those allocated to the intervention will receive the PRISMS intervention in addition to ‘Usual Care’. Randomization is stratified by site/diagnosis/Chemotherapy toxicity.. Intervention patients will be provided with a computer tablet and software prompting twice-daily completion of physical/emotional indicators (eg temperature/depression/distress) and side-effects (eg vomiting) for four treatment cycles. Should patient data exceed pre-determined limits an email alert is delivered to the treatment team with nurses logging-in to view historical data/provide clinical intervention. In addition 6 scheduled nursing interventions support patients in device usage/self care. Trial outcomes assess: symptom severity, psychological distress/anxiety/depression, quality-of-life (pen-and-paper questionnaires); health service useage/costs (medical record audit/interview); intervention compliance (system logs).Discussion: This trial is the first in the world to both develop a remote monitoring system for haematological cancer patients receiving chemotherapy and to combine the system with a nurse-led intervention. Findings from this trial are essential so that a future phase III trial is not undermined by poor compliance, recruitment/retention rates and smaller than expected effect sizes. The future use of such monitoring systems have the potential to improve patient outcomes and reduce health care costs