None listed
Conditions
Brief summary
The purpose of this study is to determine whether a smartphone-based cardiovascular risk reduction program can improve exercise capacity and heart health in patients who are undergoing treatment for breast cancer. Who is it for? You may be eligible for this study if you are an adult female who has been diagnosed with breast cancer and own a smartphone. Study details This study is a randomized controlled study recruiting consecutive patients with newly diagnosed breast cancer. This type of study is designed to make sure the researchers interpret the results in a fair and appropriate way and avoids study doctors or participants jumping to conclusion. Patients over the age of 18 with a new diagnosis of breast cancer will be eligible for inclusion. The other major inclusion criteria will be personal ownership of a smartphone. Exclusion criteria includes patients with a prognosis of less than 6 months as determined by their treating oncologist. Half of the people recruited for the trial will download the SmartPhone app. This app will then be used by participants to monitor heart health, exercise and dietary habits for 12 months. Participants will also have access to feedback from researchers in regards to their heart health as well as support from researchers. The other half will have the stand treatment for their breast cancer which doesn't include any cardiovascular input. They will have access to the treatment centre's health and wellness program which has an exercise program available. It is hoped that this research will help determine if this smartphone application is beneficial in monitoring heart health for those with breast cancer.
Interventions
All patients will receive standard of care treatment for their breast cancer. This includes inpatient and outpatient oncology review as required, planning and prescription of chemotherapy, radiotherapy, targeted therapy or hormone therapy as appropriate and promotion of self-care with access to the Breast Cancer Network Australia resources during cancer treatment.
Eligible patients will be randomized in a 1:1 fashion to a smartphone-based cardiovascular risk reduction program or usual care alon
All patients will receive standard of care treatment for their breast cancer. This includes inpatient and outpatient oncology review as required, planning and prescription of chemotherapy, radiotherapy, targeted therapy or hormone therapy as appropriate and promotion of self-care with access to the Breast Cancer Network Australia resources during cancer treatment. Eligible patients will be randomized in a 1:1 fashion to a smartphone-based cardiovascular risk reduction program or usual care alone. Randomization will be stratified by study site and will be overseen by the Centre of Cardiovascular Research and Education in Therapeutics; an independent research body within the School of Public Health and Preventive Medicine at Monash University (Melbourne, Australia). Assessors of the primary outcomes are blind to treatment allocation; however, participants are not blinded. The smartphone-based cardiovascular risk reduction program will be delivered over 12 months, starting at the beginning of cancer treatment through a smartphone app. Participants in the smartphone intervention cohort will download the intervention app into their smartphone. They will then receive education on how to use the app. The program is a multi-faceted intervention with particular emphasis on physical activity. The app provides a platform for comprehensive assessment of cardiovascular risk factors and utilizes a ‘traffic light’ system to represent target achievement. ‘High Risk’ parameters are displayed in red, ‘Suboptimal’ parameters are displayed in yellow and ‘On Target’ parameters are displayed in green. Participants will receive a notification if a risk factor parameter is not on target. Non-pharmacological and pharmacological treatment of risk factors will be prescribed according to the National Heart Foundation Secondary Prevention Guidelines[18] with up titration of medications until target parameters have been achieved. The different components are discussed in detail below: Dynamic tracking of cardiovascular risk factors - Patients will have an interactive personal dashboard highlighting the status of their cardiovascular risk factors. They will be graded depending whether they are at recommended target levels. Exercise Prescription - Patients will have access to real-time feedback of their activity levels through the app’s activity tracker which links to the iphone’s accelerometer feature. Patients will be able to monitor the number of steps taken and the distance walked. Feedback will be provided through messaging services. Dietary Habits - Dietary habits will be tracked through the app via access to the phone’s inbuilt camera. Participants will be encouraged to take photos of the food they are eating to keep record of their diet. They will have capabilities to rate and comment on the food. Interactive and Personalized Feedback - Patients will receive personalized messages via the app messaging service providing feedback on risk factor control and physical activity. Support - The messaging service also allows the patient to initiate contact if they have any questions regarding their cardiac condition. Replies will be made within one working day. Participants will be evaluated at baseline and at 12 months. Baseline assessment will include the following measurements: height, weight, waist circumference, resting heart rate and blood pressure, smoking status, fasting cholesterol and glucose levels.
Sponsors
Cardiology Department - Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients over the age of 18 with a diagnosis of breast cancer treated with any modality. The other major inclusion criteria will be personal ownership of a smartphone.
Exclusion criteria
Patients with metastatic disease and patients with a prognosis of less than 6 months as determined by their treating oncologist at the time of diagnosis. Patients who are unable to give informed consent, cannot communicate in written English will also be excluded.
Outcome results
None listed