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.
BACKGROUND
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 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
Two 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.


CONCLUSIONS
This 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.


BACKGROUND
ACTRN12614000516684 . Date registered: 12 March 2014 (registered retrospectively).
Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, East Melbourne, VIC, Australia. sibilah.breen@svha.org.au.|Department of Nursing, University of Melbourne, Melbourne, VIC, Australia. sibilah.breen@svha.org.au.|The Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia. sibilah.breen@svha.org.au.
Sibilah
S
Breen
The Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia. david.ritchie@mh.org.au.|Division of Haematology/Medical Oncology, Peter MacCallum Cancer Centre, East Melbourne, VIC, Australia. david.ritchie@mh.org.au.|Clinical Haematology & Bone Marrow Transplant Unit, The Royal Melbourne Hospital, Grattan Street, Parkville, VIC, Australia. david.ritchie@mh.org.au.|Department of Medicine, University of Melbourne, Melbourne, VIC, Australia. david.ritchie@mh.org.au.
David
D
Ritchie
Department of Nursing, University of Melbourne, Melbourne, VIC, Australia. penelope.schofield@petermac.org.|The Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia. penelope.schofield@petermac.org.|Department of Psychology, Swinburne University of Technology, Hawthorn, VIC, Australia. penelope.schofield@petermac.org.
Penelope
P
Schofield
Centre for Health Policy, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, VIC, Australia. ahsueh@unimelb.edu.au.
Ya-Seng
YS
Hsueh
Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, East Melbourne, VIC, Australia. karla.gough@petermac.org.
Karla
K
Gough
Department of Nursing, University of Melbourne, Melbourne, VIC, Australia. nick.santamaria@mh.org.au.|The Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia. nick.santamaria@mh.org.au.|Royal Melbourne Hospital, Grattan Street, Parkville, VIC, Australia. nick.santamaria@mh.org.au.
Nick
N
Santamaria
Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, East Melbourne, VIC, Australia. rose.kamateros@petermac.org.
Rose
R
Kamateros
School of Health Sciences, University of Surrey, Guildford, UK. r.maguire@surrey.ac.uk.
Roma
R
Maguire
School of Health Sciences, University of Surrey, Guildford, UK. n.kearney@surrey.ac.uk.
Nora
N
Kearney
Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, East Melbourne, VIC, Australia. sanchia.aranda@cancer.org.au.|Department of Nursing, University of Melbourne, Melbourne, VIC, Australia. sanchia.aranda@cancer.org.au.|Cancer Council Australia, New South Wales, Australia. sanchia.aranda@cancer.org.au.
Sanchia
S
Aranda
D000553:Ambulatory Care / Q000191:economics; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000191:economics; D001315:Australia; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D017048:Health Care Costs; D019337:Hematologic Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics / Q000451:nursing; D006801:Humans; D057194:Intention to Treat Analysis; D011237:Predictive Value of Tests; D019114:Remote Consultation / Q000191:economics / Q000379:methods*; D012107:Research Design; D055817:Telenursing / Q000191:economics; D013997:Time Factors; D016896:Treatment Outcome