None listed
Conditions
Brief summary
The purpose of this study is to trial a new program, led by nurses, for management of heart (cardiovascular) disease in people being treated for breast cancer. Who is it for? You may be eligible for this study if you are aged 18 or over and have been diagnosed with breast cancer in the last 6 months. Study details All participants in this study will receive the intervention, which is a clinical pathway lead by nurses. As part of this pathway, participant will be assessed by a nurse for their level of heart disease risk. Depending on their level of risk, they will then receive either information resources (if low risk) or a care plan including referrals to appropriate health professionals to manage their risk factors (if intermediate or high risk). The nurse will then follow up every six weeks (if possible, by telephone) to monitor how each participant is going managing/reducing their level of heart disease risk and make any adjustments to their care plan, including additional referrals, as needed. Finally, the nurse will provide each participant with a plan for ongoing management of heart disease risk at the end of participation in the study. As part of this trial, participants will complete some questionnaires, surveys and have some additional routine health tests like weighing and blood pressure. If required, the nurse may recommend for additional tests such as blood tests to be performed, so that information such as cholesterol levels can be used to calculate participant's risk of heart disease. It is hoped this research will demonstrate that this program is feasible to maintain, and acceptable to patients.
Interventions
Participants will take part in a nurse-led clinical pathway (implemented by a research nurse employed specifically for this purpose), according to an individually tailored care plan for reducing risk of/managing cardiovascular disease, including but not limited to cardiotoxicity. To implement the pathway, the nurse will lead and coordinate the participant’s care and engage necessary interdisciplinary skills of the wider clinical team (cancer specialists, cardiology specialists, primary care support) as required. The pathway will consist of the following steps: 1. Initial screening for CVD risk factors and risk stratification for all participants. Each participant will receive an initial screening assessment by the research nurse, leading to development of a care plan. The initial screening assessment will review (a) risk factors: (i) assessment of cardiovascular disease risk using the Heart Foundation’s Australian absolute cardiovascular disease risk calculator (includes age, gender, systolic blood pressure, smoking status, total cholesterol, HDL cholesterol, diabetes, and ECG-diagnosed left ventricular hypertrophy, if known); (ii) elevated risk of cardiovascular disease due to exposure to cardiotoxic anti-cancer treatment; and (iii) general health assessment, including assessment of previous history of cardiovascular disease, body mass index, and lifestyle behaviours (smoking, diet, exercise), (b) medications; (c) self-management ability/use of self-management strategies; and (d) patients’ needs and preferences for care. Following risk assessment, participants will be stratified as being at low, intermediate, or high risk of cardiovascular disease, in order to facilitate a stratified approach to risk management. Duration of this assessment will be 30 minutes; it will occur within 2 weeks of referral/consent to participate and will be a face to face, one on one assessment. 2. Development of a care plan and appropriate referrals. Participants will receive a care plan consistent with their risk stratification. Participants identified as being at LOW risk of cardiovascular disease (i.e. no risk factors other than cancer treatment) will receive printed resources aiming to provide information on cardiovascular disease risk prevention and reduction. These will include a purpose-developed print resource "Breast cancer and heart disease" which has been developed based on information from the Heart Foundation and National Comprehensive Cancer Network, along with print resources from Cancer Council Australia ("Exercise for people living with cancer", and "Nutrition and cancer". Participants identified as being at INTERMEDIATE risk of cardiovascular disease will receive a more detailed care plan including nurse-led surveillance of cardiovascular health (delivered using phone, or telemedicine approaches where possible), prevention and management strategies (pharmacological and non-pharmacological including self-management strategies), and strategies for seeking help, if needed. Interventions will focus on the modification of existing risk factors according to accepted guidelines for the general population including: smoking cessation, management of obesity, elevated blood pressure, lipids and impaired glucose tolerance through lifestyle and/or pharmacologic interventions. Participants identified as being at HIGH risk of cardiovascular disease (i.e. existing comorbid cardiovascular disease) will receive a detailed care plan as above, in addition to referral to a cardiologist for further management. For all participants, the care plan will be integrated with the patient’s cancer care and overall care, including primary care. Duration of this step will be 60 minutes; it will occur within two weeks of referral/consent to participate in the pathway, and will occur face to face, one on one with the research nurse. 3. Regular review of care plan, clinical outcomes and modification of plan to address goals and problems. All participants will attend/receive follow-up reviews every six weeks, including review of quality of life, lifestyle behaviours (diet, exercise, smoking), body mass index, blood pressure, cholesterol levels, lipids (if appropriate), currently used medications, and any cardiac events or other adverse events over the intervening period. Whenever possible reviews will be performed via telephone. Care plans will be adjusted as needed in response to review. Reviews will occur every six weeks and will be 30 minutes duration; they will occur either via telephone (preferred where possible to minimise disruption to participants) or face to face. 4. Initiation of separate pathway if cardiac toxicity develops. Any participants who develop cardiotoxicity in response to their cancer treatment will be responded to through implementation of a separate clinical pathway, including an assessment and management plan incorporating input from oncology, cardiology, and other relevant providers. This step (relevant only if cardiotoxicity develops) will be between 30 and 60 minutes duration and will occur face to face, one on one with the research nurse. 5. Transition of care to primary care when acute phase of care is completed. When the participant’s acute anti-cancer treatment has been completed, their long-term care/management of cardiovascular disease will be integrated into the overall survivorship care plan. This will include engagement with primary care providers and with community supports (e.g. Flinders Centre for Innovation in Cancer survivorship clinic and Flinders Cancer Wellness Program, Cancer Council and Heart Foundation resources for healthy living) to facilitate long-term care. Development of this transition plan will be of 30-60 minutes duration and will occur one on one with the research nurse, either either face to face or via telephone (as preferred by the participant). The overall duration of the intervention (per participant) will be three months from initial enrollment/assessment to final assessment and development of the transition plan.
Sponsors
Study design
Eligibility
Inclusion criteria
Key inclusion criteria are: (a) adults (aged over 18 years) (b) have sufficient English language ability to provide informed consent (assessed via approaching clinician upon approach) (c) newly diagnosed with breast cancer or diagnosed within the past 6 months (d) life expectancy of one year or more (according to the treating oncologist’s estimate)
Exclusion criteria
Patients will be excluded if they are assessed by the approaching clinician to have: (a) clinically significant/elevated distress, or (b) significant cognitive impairment that may impact ability to give informed consent or participate effectively, or (c) to be too unwell to comfortably participate (e.g. end stage disease). No other exclusion criteria will apply.