Changing Clinical Practice
The Kids Cancer Alliance has supported several implementation research projects that have led to changes in clinical practice:
2017 Electronic Medical Records
Project: The impact of electronic clinical systems on medication safety and workload in oncology
The project compares the clinical workload in paediatric oncology with other paediatric specialities after the implementation of electronic medication management at the Children’s Hospital Westmead.
The impact of electronic clinical systems on medication safety and workload in oncology.
Sydney Children’s Hospital Network (Sydney Children’s Hospital, Randwick and The Children’s Hospital, Westmead) is implementing an electronic medical record that is expected to extract efficiencies in workflows, reduce risks faced by patients, and improve the quality of patients’ experiences with the health care system. A fully integrated electronic medical record will promote and support compliance with oncology treatment protocols to deliver safer and more responsive care through reduction of risks and errors by standardising complex treatment protocols, particularly chemotherapy ordering and administration. The project will measure: (i) Quality – patient care through improved and promptly accessible clinical documentation and better coordination of care across different care settings and variations in treatment; (ii) Safety – reduction of adverse drug events by improved medical handover in hospital/community shared care teams; (iii) Efficiency – appropriate diagnostic and follow-up testing and reduction in length of stay; and (iv) Satisfaction – enhanced experience for patient and families and improved staff satisfaction. The results will inform evidence-based decisions about design and use of these systems to promote best practice in paediatric oncology across Australia.
2017 Childhood Cancer Survivorship
Improving the model of care for child cancer survivors at risk of late side-effects of successful anti-cancer therapy.
Improving the model of care for child cancer survivors (CCS) at risk of late side-effects of successful anti-cancer therapy
Earlier research by the Behavioural Sciences Unit (BSU) at the Kids Cancer Centre Randwick suggest many survivors have unmet information needs, report barriers to care, and are not engaged in any cancer-related follow-up care despite experiencing a large number of health issues.
While research on improving survival outcomes for children is important, with increased success of survivorship comes the need to reduce the late effects of cancer treatment that childhood cancer survivors are experiencing.
A study by the BSU of the feasibility of primary care (general practitioners/GPs) involvement in long-term follow-up of childhood cancer survivors suggests general practitioners lack confidence caring for childhood cancer survivors but are willing to become their primary carers with the right information and support from tertiary services.
To address long-term care the BSU developed and evaluated an e-healthcare platform with which survivors, specialists and GPs may manage coordinated survivorship care plans.
This e-tool will now be modified and tested in a randomised controlled trial of a new survivorship intervention entitled ‘Re-engage’ in an effort to maximise the quality of life of childhood cancer survivors.
2016 Precision Diagnostics and Personalised Medicine
Project: Improving therapeutic outcomes through precision diagnostics
KCA has funded pharmacokinetic measurement of asparaginase levels over the past 6 years for acute lymphoid leukaemia patients treated on iBFM Study 9. These values are used clinically to adjust the dose of therapeutic PEG-Asparaginase.
Monitoring Busulfan levels is now standard of care in children and adults receiving bone marrow transplant after KCA funded research into teleomere length and treatment outcomes.
Improving therapeutic outcomes through precision diagnostics
20% of children diagnosed with cancer will relapse, and most will die of their disease. Moreover, the chemotherapy toxicity in survivors is extreme in the growing child, resulting in significant late health effects. Better diagnostics are needed to predict relapse and treatment toxicity. KCA researchers have contributed major diagnostic discoveries in the fields of cancer biomarkers, pharmacokinetics and short telomere syndromes which have altered the model of child cancer care. These advances, coupled with new KCA-funded research in these areas, have led to an internationally unique precision medicine diagnostic platform for high risk child cancer patients.
KCA researchers have had a major impact in the development of novel diagnostics which have changed the way in which paediatric oncologic therapy is delivered (minimal residual disease testing, pharmacokinetics, Zero Childhood Cancer Program), and, in the minimisation of toxicities (pharmacokinetics, telomere testing). More than 60% of newly diagnosed child cancer patients go on to a clinical trial, thus “clinical care is research” in paediatric oncology. Ongoing KCA research is completely changing the paradigm for relapse therapy and side-effect minimisation.
Minimal residual disease testing is now standard of care for children in NSW diagnosed with acute lymphoid leukaemia. Children with acute lymphoid leukaemia are enrolled on a clinical trial as the routine model of care. The minimal residual disease test designed by KCA researchers is used to stratify children with slow early minimal residual disease responses to high risk therapies, such as allogeneic bone marrow transplant. From 2002-2011 the acute lymphoid leukaemia Study 8 trial (Leukaemia 2013) increased the cure rate for minimal residual disease high-risk acute lymphoid leukaemia patients from 35% to 70% with intensified therapy (Level B). Indeed, the current international AEOIP-iBFM acute lymphoid leukaemia 2009 trial used in NSW for acute lymphoid leukaemia was built around the use of minimal residual disease testing. Minimal residual disease testing is also used in children with relapsed acute lymphoid leukaemia to identify children who need an allogeneic bone marrow transplant in second remission, and, before bone marrow transplant to distinguish those children who will fail bone marrow transplant without further induction therapy (Level B). KCA has funded pharmacokinetic measurement of asparaginase levels over the past 6 years for acute lymphoid leukaemia patients treated on iBFM Study 9. These values are used clinically to adjust the dose of therapeutic PEG-Asparaginase (Level A).
The discovery by KCA researchers of telomerase and ALT as mechanisms for lengthening telomeres has been applied in NSW with the recent development of a telomere length assay which is used to identify individuals with dyskeratosis congenita who might present with progressive marrow failure and need a bone marrow transplant (Level B). These patients suffer severe side-effects if administered conventional bone marrow transplant conditioning. It is essential that patients with short telomeres receive a reduced intensity conditioning (Level B). Recent KCA research has defined a new risk group of children with acute lymphoid leukaemia with short telomeres, without dyskeratosis congenita, but who are at high risk of treatment toxicity, extending the paradigm of toxicity prevention to the commonest childhood malignancy, acute lymphoid leukaemia.
Monitoring Busulfan levels is now standard of care in children and adults receiving bone marrow transplant. Moreover, recent studies by the KCA pharmacokinetics group confirmed that this strategy not only reduces toxicity, but also increases efficacy of the drug in the bone marrow transplant setting, and, has led to measurement of other bone marrow transplant conditioning agents, such as Treosulfan (Level A).
Finally, the diagnostic platform used in the national Zero Childhood Cancer trial for high risk child cancer will enrol 100 children each year in an effort to improve cure rates by better matching drug to target. This individualised treatment project arose directly from the KCA-funded molecular profiling project (Level A) and our prior minimal residual disease work.
2015 Fertility Preservation
Project: Implementation research on fertility preservation models of care.
Competencies for health care services and health care providers in onco-fertility preservation are being developed to ensure that providers develop knowledge, skills and processes to deliver services of a high standard and this includes suitable models of care and referral pathways. A number of applications have been submitted to the Australian Government’s Medicare to have fertility preservation items added to the Medicare Benefits Schedule and improve access to these services for adolescents and young adults with cancer.
Models of Care – Fertility Preservation
Despite international evidence about the benefits of fertility preservation and current national and international guidelines there are several barriers that have prevented the implementation of equitable fertility preservation practice around the world. These barriers include a lack of referral pathways and models of care for oncofertility services, the need for more collaborations between cancer and fertility doctors, inequitable access based on cost and a lack of oncofertility training. There is also no consensus about the best way to deliver oncofertility information to patients. Dr Antoinette Anazodo and her group are currently developing competencies for health care services and health care providers to ensure that they develop knowledge, skills and processes to deliver services of a high standard and this includes suitable models of care and referral pathways.
A series of comprehensive literature searches were performed in April 2017.
Evidence from the literature review was converted into two questionnaires – one for health care professionals and one for patient representatives. The questionnaire contains sections related to positive strategies identified in the research relating to each of the domains.
Dr. Anazodo has collaborated with partners from around the world on this study – UK, German, Portugal, USA, Japan, India, China, New Zealand and the South American Oncofertility Consortium. The questionnaire is available in 9 languages – Arabic, French, German, Hindi, Japanese, Mandarin, Spanish and Portuguese for Portugal and South America. Consensus was considered to be achieved if 90% or participants agree with a questionnaire statement.
On the basis of the responses received, a second questionnaire will be developed, which will be sent electronically back to the same group of participating health care professionals. Our intention is to reach an agreement of 90% and a third questionnaire will be developed if required to meet consensus.
The results will be used to develop an international competency framework document that will be translated into the 9 languages involved in this study.
Implementation research on fertility preservation service models:
Dr Anazodo has successfully advocated for cancer patients (adult and child) to the federal government to ensure universal availability of fertility preservation technology. This work is aimed at dramatically reducing costs for all NSW and Australian cancer patients and improving access to fertility preservation services.
The following are reports submitted to support Medicare subsidised fertility preservation.
Department of Health Reports
- Protocol Advisory Subcommittee Report 35750– Ovarian Repositioning. March 2016. New Medicare Benefits Schedule (MBS) Items 35730: Ovarian Repositioning started 1st May 2017.
- Protocol Advisory Subcommittee Report 1434 – Anti-Müllerian Hormone (AMH) MBS listing for female patients who will or have received gonadotoxic treatment. Recommended for approval 15th January 2018.
- Protocol Advisory Subcommittee Report 1435a– Protocol to guide the assessment of processing and cryopreservation of male gonadal tissue and gametes prior to gonadotoxic treatment to preserve fertility for the future. Accepted by ESC November 2017 and awaiting Minister Hunt’s approval in the next budget.
- Protocol Advisory Subcommittee Report 1435b– Protocol to guide the assessment of processing and cryopreservation of female gonadal tissue and gametes prior to gonadotoxic treatment to preserve fertility for the future. Recommended for approval 15th January 2018.
- Protocol Advisory Subcommittee Report 1436– Protocol to guide the development of Oncofertility Psychological Health Treatment Plan for assessment and support of fertility related psychological distress in cancer patients at diagnosis and following cancer treatment. Review currently ongoing.
2013 Rural Cancer Patients – Fever and Neutropenia
Project: Improving Supportive Care for Rural Cancer Patients
To improve the timing of administration of antibiotics to a febrile child with cancer, particularly in rural areas, an intervention plan is being developed and will include education and issue of a ‘port pack’ to parents/carers of patients on first discharge.
Improving supportive care of infection in child cancer patients treated at rural hospitals.
The project aims to identify barriers preventing timely administration of antibiotics to child cancer patients with fever in tertiary or regional care centres. This project is a collaboration between paediatric oncology services in NSW and Queensland. Queensland data collection was completed at both metropolitan and regional sites for nearly 400 patients, and found 61% had a time to antibiotics of less than 1hour at the Lady Cilento Hospital and 50% for regional patients. In NSW, a total of 520 admissions have been collected prospectively as per ethics guidelines at both Sydney Children’s Hospital and The Children’s Hospital at Westmead. Of this total, 258 were Oncology/bone marrow transplant presentations at Children’s Hospital Westmead Emergency Department or Oncology Treatment Centre. The remaining 262 were seen at Sydney Children’s Hospital Emergency Department. 118 patients were neutropenic and 144 non-neutropenic at Sydney Children’s Hospital. 107 patients were neutropenic and 151 non- neutropenic at Children’s Hospital Westmead. The focus currently remains on increasing rural data and also data input for analysis.
An interventions plan is being developed including: videoconferencing, education sessions, improving access delays, utilisation of the Oncology Family App, education of parents and staff on a clinical pathway, topical anaesthetic, regional tick sheet, phone advice, consistent discharge advice, and development of a regional ‘port pack’ for patients on first discharge – port needle, drug dose and schedule, contacts, pathway.