Background: Outpatient chemotherapy is a core treatment for haematological malignancies; however, its toxicities\nfrequently lead to distressing/potentially life-threatening side-effects (neutropenia/infection, nausea/vomiting, mucositis,\nconstipation/diarrhoea, fatigue). Early detection/management of side-effects is vital to improve patient outcomes,\ndecrease morbidity and limit lengthy/costly hospital admissions. The ability to capture patient-reported health data in\nreal-time, is regarded as the ââ?¬Ë?gold-standardââ?¬â?¢ to allow rapid clinical decision-making/intervention. This paper presents the\nprotocol for a Phase 3 multi-site randomised controlled trial evaluating a novel nurse-led Telehealth intervention for\nremote monitoring/management of chemotherapy side-effects in Australian haematological cancer patients.\nMethods/Design: Two hundred and twenty-two patients will be recruited from two hospitals. Eligibility criteria\ninclude: diagnosis of chronic lymphocytic leukaemia/Hodgkinââ?¬â?¢s/non-Hodgkinââ?¬â?¢s lymphoma; agedââ?°Â¥ 18 years; receiving\nââ?°Â¥ 2 cycles chemotherapy. Patients will be randomised 1:1 to either the control or intervention arm with stratification by\ndiagnosis, chemotherapy toxicity (high versus low), receipt of previous chemotherapy and hospital. Patients allocated\nto the control arm will receive ââ?¬Ë?Usual Careââ?¬â?¢ whilst those allocated to the intervention will receive the intervention in\naddition to ââ?¬Ë?Usual Careââ?¬â?¢. Intervention patients will be provided with a computer tablet and software prompting\ntwice-daily completion of physical/emotional scales for up to four chemotherapy cycles. Should patient data exceed\npre-determined limits an Email alert is delivered to the treatment team, prompting nurses to view patient data, and\ncontact the patient to provide clinical intervention. In addition, six scheduled nursing interventions will be completed\nto educate/support patients in use of the software. Patient outcomes will be measured cyclically (midpoint and end of\ncycles) via pen-and-paper self-report alongside review of the patient medical record. The primary outcome is burden\ndue to nausea, mucositis, constipation and fatigue. Secondary outcomes include: burden due to vomiting and\ndiarrhoea; psychological distress; ability to self-manage health; level of cancer information/support needs and;\nutilisation of health services. Analyses will be intention-to-treat. A cost-effectiveness analysis is planned.\nDiscussion: This trial is the first in the world to test a remote monitoring/management intervention for adult\nhaematological cancer patients receiving chemotherapy. Future use of such interventions have the potential to\nimprove patient outcomes/safety and decrease health care costs by enabling early detection/clinical intervention.
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