Abstract
BackgroundOutpatient chemotherapy is a core treatment for haematological malignancies; however, its toxicities frequently lead to distressing/potentially life-threatening side-effects (neutropenia/infection, nausea/vomiting, mucositis, constipation/diarrhoea, fatigue). Early detection/management of side-effects is vital to improve patient outcomes, decrease morbidity and limit lengthy/costly hospital admissions. The ability to capture patient-reported health data in real-time, is regarded as the ‘gold-standard’ to allow rapid clinical decision-making/intervention. This paper presents the protocol for a Phase 3 multi-site randomised controlled trial evaluating a novel nurse-led Telehealth intervention for remote monitoring/management of chemotherapy side-effects in Australian haematological cancer patients.Methods/DesignTwo hundred and twenty-two patients will be recruited from two hospitals. Eligibility criteria include: diagnosis of chronic lymphocytic leukaemia/Hodgkin’s/non-Hodgkin’s lymphoma; aged ≥ 18 years; receiving ≥ 2 cycles chemotherapy. Patients will be randomised 1:1 to either the control or intervention arm with stratification by diagnosis, chemotherapy toxicity (high versus low), receipt of previous chemotherapy and hospital. Patients allocated to the control arm will receive ‘Usual Care’ whilst those allocated to the intervention will receive the intervention in addition to ‘Usual Care’. Intervention patients will be provided with a computer tablet and software prompting twice-daily completion of physical/emotional scales for up to four chemotherapy cycles. Should patient data exceed pre-determined limits an Email alert is delivered to the treatment team, prompting nurses to view patient data, and contact the patient to provide clinical intervention. In addition, six scheduled nursing interventions will be completed to educate/support patients in use of the software. Patient outcomes will be measured cyclically (midpoint and end of cycles) via pen-and-paper self-report alongside review of the patient medical record. The primary outcome is burden due to nausea, mucositis, constipation and fatigue. Secondary outcomes include: burden due to vomiting and diarrhoea; psychological distress; ability to self-manage health; level of cancer information/support needs and; utilisation of health services. Analyses will be intention-to-treat. A cost-effectiveness analysis is planned.DiscussionThis trial is the first in the world to test a remote monitoring/management intervention for adult haematological cancer patients receiving chemotherapy. Future use of such interventions have the potential to improve patient outcomes/safety and decrease health care costs by enabling early detection/clinical intervention.Trial registrationACTRN12614000516684.Date registered: 12 March 2014 (registered retrospectively).
Highlights
Outpatient chemotherapy is a core treatment for haematological malignancies; its toxicities frequently lead to distressing/potentially life-threatening side-effects
We have developed a dual intervention, the Patient Remote Intervention and Symptom Management System (PRISMS) which combines a remote monitoring system based on the Advanced Symptom Management System (ASyMS) system developed by the authors [36, 43] with an evidence-based nurse-led intervention to improve patient outcomes during chemotherapy
Given the aging of the Australian population and the consequent expected increase in people diagnosed with cancer, it is imperative to find cost-effective strategies to improve the quality and safety of cancer care in the community whilst improving patient outcomes
Summary
The proposed system combines cutting edge technology with systematic evidence-based, nursing consultation. It is the first system designed to monitor adult patients with haematological cancers undergoing chemotherapy It is the first randomised controlled trial of any Telehealth- mediated nurse-led intervention for cancer patients and builds from earlier ASyMS work and will, in tandem with the current large European (>1000 patients) ASyMS randomised controlled trial, add to our growing knowledge of the impact of these interventions on patient health outcomes and health system costs. Nursing interventions, combined with remote monitoring systems, such as those described in this protocol, are, likely to enable both more accurate symptom monitoring and management, combined with greater efficiency and effectiveness of nursing roles in haematology Trial status This trial is currently in the process of recruiting patients.
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