The Patient Remote Intervention and Symptom Management System (PRISMS) – a Telehealth- mediated intervention enabling real-time monitoring of chemotherapy side-effects in patients with haematological malignancies: study protocol for a randomised controlled trial

摘要: Outpatient 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 vital improve patient outcomes, decrease morbidity and limit lengthy/costly hospital admissions. The ability capture patient-reported health data in real-time, regarded as the ‘gold-standard’ allow rapid clinical decision-making/intervention. This paper presents protocol Phase 3 multi-site randomised controlled trial evaluating novel nurse-led Telehealth intervention remote monitoring/management Australian cancer patients. Two hundred twenty-two patients will be recruited from two hospitals. Eligibility criteria include: diagnosis chronic lymphocytic leukaemia/Hodgkin’s/non-Hodgkin’s lymphoma; aged ≥ 18 years; receiving ≥ 2 cycles chemotherapy. Patients 1:1 either control or arm with stratification by diagnosis, toxicity (high versus low), receipt previous hospital. allocated receive ‘Usual Care’ whilst those addition Care’. Intervention provided computer tablet software prompting twice-daily completion physical/emotional scales up four cycles. Should exceed pre-determined limits an Email alert delivered team, nurses view data, contact provide intervention. In addition, six scheduled nursing interventions completed educate/support use software. Patient outcomes measured cyclically (midpoint end cycles) via pen-and-paper self-report alongside review medical record. primary outcome burden due nausea, constipation fatigue. Secondary vomiting diarrhoea; psychological distress; self-manage health; level information/support needs and; utilisation services. Analyses intention-to-treat. A cost-effectiveness analysis planned. first world test adult receiving Future such have potential outcomes/safety care costs enabling early detection/clinical ACTRN12614000516684 . Date registered: 12 March 2014 (registered retrospectively).