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Trial registered on ANZCTR


Registration number
ACTRN12620000439943p
Ethics application status
Submitted, not yet approved
Date submitted
23/02/2020
Date registered
6/04/2020
Date last updated
6/04/2020
Date data sharing statement initially provided
6/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing the risk of heart disease in people with breast cancer
Scientific title
A nurse-led clinical pathway to reduce the burden of cardiovascular disease in breast cancer patients and survivors: Phase 2 - Pilot Implementation Trial
Secondary ID [1] 300576 0
Nil
Universal Trial Number (UTN)
Not applicable
Trial acronym
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
breast cancer 316309 0
cardiovascular disease 316310 0
Condition category
Condition code
Cancer 314575 314575 0 0
Breast
Cardiovascular 314576 314576 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 316950 0
Treatment: Other
Comparator / control treatment
No control group (study is a single arm pilot implementation trial).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322907 0
Feasibility, measured as adherence to the pathway and care plan (appointment, review, adherence to recommended interventions and referrals).
Timepoint [1] 322907 0
3 months after initial assessment and initiation of the pathway.
Secondary outcome [1] 380214 0
Patient activation, measured using the revised Partners in Health scale.
Timepoint [1] 380214 0
3 months after initial assessment and initiation of the pathway.
Secondary outcome [2] 380415 0
Quality of life, measured using the Revised Edmonton Symptom Assessment Scale
Timepoint [2] 380415 0
3 months after initial assessment and initiation of the pathway.
Secondary outcome [3] 380416 0
Health Service Utilisation,measured using the Australian Bureau of Statistics Health Service Utilisation Questionnaire
Timepoint [3] 380416 0
3 months after initial assessment and initiation of the pathway.
Secondary outcome [4] 380417 0
Health literacy, Measured using the first two items of the revised Partners in Health scale (which assess knowledge of condition, knowledge of treatment of condition).
Timepoint [4] 380417 0
3 months after initial assessment and initiation of the pathway.
Secondary outcome [5] 380418 0
Diet, measured using the CSIRO healthy diet score
Timepoint [5] 380418 0
3 months after initial assessment and initiation of the pathway.
Secondary outcome [6] 380419 0
Cardiovascular disease risk, measure using the Australian absolute cardiovascular disease risk calculator (composite calculation which takes into account gender, age, blood pressure, smoking status, total and HDl cholesterol, diagnosis of diabetes, and ECG left ventricular hypertrophy, if known).
Timepoint [6] 380419 0
3 months after initial assessment and initiation of the pathway.
Secondary outcome [7] 380420 0
Number and severity of cardiac events, based on participant self-report and check of patient notes.
Timepoint [7] 380420 0
3 months after initial assessment and initiation of the pathway
Secondary outcome [8] 380421 0
Uptake (proportion of patients agreeing to take part in the intervention)
Timepoint [8] 380421 0
End of study
Secondary outcome [9] 380422 0
Acceptability of the intervention to patients and providers (measured via self-report survey), using a series of Likert-style items developed specifically for this study based on similar surveys used for our group's prior research.
Timepoint [9] 380422 0
3 months after initial assessment and initiation of the pathway (patients); end of study (providers)
Secondary outcome [10] 380423 0
Cost (costs of intervention and health care utilisation); assessed by recording costs of intervention and health care utilisation including staff time and pharmaceuticals. Micro-costing methods using a bottom-up approach will be used to estimate costs associated with implementation, delivery and evaluation of the intervention for the study duration from a health care perspective. Material costs will be identified and resource use for all time quantity estimates recorded in observational field notes as part of the process evaluation. Unit costs for each resource will be estimated using current Australian market values and South Australian public sector wage scales. The unit cost of each resource will then be multiplied by the recorded quantities and reported as trial costs and costs per patient. Total trial costs will be further disaggregated into total study trial costs and total intervention costs.
Timepoint [10] 380423 0
End of study (assessment of overall cost)
Secondary outcome [11] 381354 0
Smoking, measured using items from the Australian Bureau of Statistics. National Health Survey 2011–12.
Timepoint [11] 381354 0
3 months from initial assessment.
Secondary outcome [12] 381355 0
Physical activity, measured using the The Active Australia Survey (Australian Institute of Health and Welfare).
Timepoint [12] 381355 0
3 months from initial assessment
Secondary outcome [13] 381356 0
Body composition, assessed using the participant's body mass index, calculated from weight and height measurements taken by the research nurse. weight measurements will be assessed using digital scales, height measurement will be assessed using stadiometer.
Timepoint [13] 381356 0
3 months from initial assessment
Secondary outcome [14] 381357 0
Quality-adjusted life years; calculated by combining responses to the EQ-5D-5L with survival data.
Timepoint [14] 381357 0
3 months from initial assessment

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable - single arm trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable - single arm trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
single arm pilot implementation trial
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All statistical analysis will be conducted using Stata version 16.0. Study outcomes and their measurement will be expressed as median and inter quartile range (IQR) for continuous skewed data and proportions will be presented as percentages of the respective denominator. Wilcoxon signed -ranked test and standard McNemar test for paired proportion, where appropriate, will be used. Mean and Standard deviation will also be expressed for continuous non-skewed data with a standard paired t-test. Micro-costing methods using a bottom-up approach will be used to estimate costs associated with implementation, delivery and evaluation of the intervention for the study duration from a health care perspective. Material costs will be identified and resource use for all time quantity estimates recorded in observational field notes as part of the process evaluation

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2020
Actual
Date of last participant enrolment
Anticipated
26/02/2021
Actual
Date of last data collection
Anticipated
28/05/2021
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 15948 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 29432 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 304993 0
Charities/Societies/Foundations
Name [1] 304993 0
National Breast Cancer Foundation
Country [1] 304993 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100 Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 305411 0
None
Name [1] 305411 0
Address [1] 305411 0
Country [1] 305411 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305395 0
Southern Adelaide Clinical Human Resarch Ethcis Committee
Ethics committee address [1] 305395 0
Ethics committee country [1] 305395 0
Australia
Date submitted for ethics approval [1] 305395 0
17/03/2020
Approval date [1] 305395 0
Ethics approval number [1] 305395 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100230 0
Prof Bogda Koczwara
Address 100230 0
Level 4 Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country 100230 0
Australia
Phone 100230 0
+61 8 8204 8997
Fax 100230 0
Email 100230 0
bogda.koczwara@flinders.edu.au
Contact person for public queries
Name 100231 0
Emma Kemp
Address 100231 0
Level 4 Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country 100231 0
Australia
Phone 100231 0
+61 8 7421 9954
Fax 100231 0
Email 100231 0
emma.kemp@flinders.edu.au
Contact person for scientific queries
Name 100232 0
Emma Kemp
Address 100232 0
Level 4 Flinders Centre for Innovation in Cancer
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country 100232 0
Australia
Phone 100232 0
+61 8 7421 9954
Fax 100232 0
Email 100232 0
emma.kemp@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.