Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001005549
Ethics application status
Approved
Date submitted
16/07/2024
Date registered
20/08/2024
Date last updated
20/08/2024
Date data sharing statement initially provided
20/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
IMplementation and Prospective evAluation of dedicated Cardio-oncology services for prevention, monitoring and Treatment of CardioVascular Diseases in patients living with, through and beyond CANCER (IMPACT-CVD in CANCER trial)
Scientific title
IMplementation and Prospective evAluation of dedicated Cardio-oncology services for prevention, monitoring and Treatment of CardioVascular Diseases in patients living with, through and beyond CANCER (IMPACT-CVD in CANCER trial)
Secondary ID [1] 312365 0
None
Universal Trial Number (UTN)
Trial acronym
IMPACT-CVD in CANCER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 334152 0
cardiovascular disease 334153 0
Condition category
Condition code
Cancer 330823 330823 0 0
Any cancer
Cardiovascular 330824 330824 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention and implementation strategies will be delivered sequentially at 3 sites at 3-monthly intervals, after a prospective pre-intervention period of 8 months at the first site. Repeated cross-sectional outcome data will be gathered across all three sites for the total study duration and data collection period of 30 months.

Following the baseline data collection (pre-intervention) period, each site will receive a systems-based intervention. A nurse-led, physician-supported cardio-oncology risk stratification clinic designed to meet the key evidence-based recommendations of the first international cardio-oncology guidelines will be implemented. The clinic, integrated with cancer services, will be focused on guideline-directed: a) baseline preventable cancer and cardiovascular risk assessment and management; and b) appropriate cancer and cardiovascular risk surveillance during and after cancer treatment. The components and frequency of ongoing surveillance will depend on the patient’s baseline risk assessment, as per guidelines. All follow-up visits will be conducted as per recommendations in the cardio-oncology guidelines. The following will be undertaken:

Referral to cardio-oncology clinic: Eligible patients will be identified utilising electronic health records by nurses based on the published guidelines. Patients will be pre-screened, and those identified as at medium or moderate cardiovascular toxicity risk will receive a referral letter to the cardio-oncology clinic. Patients are then provided with a clinic appointment (within 3-4 weeks of initial referral). At the first clinic appointment, the nurse will complete the following patient screening:
Baseline Cardiovascular Risk Assessment: Baseline cardiovascular risk assessment and management will consist of determining the risk of cardiovascular complications of anti-cancer therapy as per guidelines and allows appropriate surveillance planning. The HFA-ICOS risk assessment tool will be used to assess risk in patients with cancer scheduled to receive cardiotoxic anticancer therapy. A standardized approach for all patients will include a focus on the management of shared cancer and cardiovascular risk factors: hypertension, dyslipidaemia, hyperglycaemia, smoking, alcohol consumption, poor diet, and exercise; and the prescription of cardiovascular medications (by the supporting physician). The nurse-led cardio-oncology clinic focusses on cardiovascular risk stratification, management, education as well as lifestyle, pharmacological and non-pharmacological interventions This will include individualized, patient-centred assessments of risk factors for prevention and early the provision of education and support towards making positive lifestyle changes that reduce the risk of CVD in cancer patients longer term. Management of risk factors will be undertaken according to the European Society of Cardiology (ESC) guidelines on cardiovascular disease prevention in clinical practice. For example, it is recommended treatment goals for risk factors be achieved in a stepwise approach, with the first step being to achieve recommended goals for blood pressure and cholesterol levels through lifestyle recommendations and medication if needed. Blood pressure will be measured at each clinic appointment. All medication prescriptions will be protocol driven, derived from the current Australian cancer and cardiovascular guidelines. The supporting physician will assess patients either face-to-face or via telehealth if required. This involves a time estimation of 1 hour for baseline assessment, and 30 – 45 minutes follow-up appointment at 6 months and/or 12 months. The components and frequency of ongoing surveillance will depend on the baseline risk assessment, as per guidelines. All follow-up visits will be conducted as per recommendations in the cardio-oncology recommendations. For example, the international position statement on cardiovascular assessment for people with cancer, (from the the Heart Failure Association of the European Society of Cardiology Cardio-Oncology Study Group in collaboration with the International Cardio-Oncology Society) describes that the timing and nature of CV surveillance recommendations depends upon several factors including the cardiotoxicity profile of the cancer therapy, the risk factors contributing to the risk level calculation and patient preference. However, all patients are recommended a 6-month and/or 12-month follow-up clinic appointment. Their GP is also provided a summary of their care.

Implementation strategies
Evidence-based (Cochrane-EPOC) implementation strategies will provide support for implementation of the IMPACT-CVD in CANCER intervention at each site. These include:
1. Local clinical guidelines: Specific for cardio-oncology care outlining the steps to undertake the intervention will be provided to staff. This will be provided in the form of a manual that will be provided to all relevant staff. This will describe the required tasks, including assessment and referral of patients to clinics and the intervention care elements. This document will be provided to all relevant staff via email.
2. Staff education and training: A training package, including online and face-to-face training addressing referral to the clinic and the intervention care elements; case studies. The research team will provide training to all applicable staff (approximately 3 hours training) 2 weeks before the start of the intervention. This will incorporate a shared care model between cardiology and oncology with multidisciplinary case presentations, consistent updated cardio-oncology seminars given to oncology and hematology departments; executive support with implementation of clinic, and referral infrastructure is embedded in care processes. Clinician education materials and activities for clinical staff of oncology and haematology departments will include evidence of need (toxicities), cardiovascular treatment effectiveness, benefits of such treatment for continuation of cancer treatment and patient benefits (both cancer and cardiovascular); and implementation of feedback from cardiovascular clinic to treating cancer.
3. Systems support: Modification to existing clinical prompts/medical record/referral and discharge systems/processes to facilitate referral to the clinic and delivery of the intervention.
4. Audit and feedback: Clinic performance reports of care delivery and outcomes will be monitored in monthly clinic team meetings. Site-specific feedback reports will be emailed to the project advisory group, including the local relevant staff at each site (e.g. oncologist, nurses), each month, for the duration of the intervention. The regular feedback will serve as a reminder and the feedback report will also include education, with links to applicable sections of the relevant guidelines serving as reminders, and summaries of evidence for the baseline CV risk assessment.
5. Prompts/reminders: Will be used to provide point of care guidance to clinicians regarding model of care elements (e.g. prompt cards; ward flow, clinician communication).
6. Consumer resources package: Patients will also receive a package of existing resources including ESC Clinical Practice Guidelines for patients.
Intervention code [1] 328863 0
Early detection / Screening
Intervention code [2] 328864 0
Prevention
Comparator / control treatment
Prior to implementation of the intervention, all hospitals will receive standard cardio-oncology care in hospital. During this baseline period, current normal cardio-oncology care will continue at each site. Standard care will differ at each site depending on their current usual practice and may also differ by clinicians within sites.
Control group
Active

Outcomes
Primary outcome [1] 338686 0
Complete baseline CV risk assessment (primary implementation outcome)
Assessment method [1] 338686 0
Proportion of patients with cancer who receive complete baseline CV risk assessment and guideline-directed management, and guideline-directed surveillance. Assessed via review of medical records.
Timepoint [1] 338686 0
Electronic health records data to be extracted for each eligible patient during the study period - assessed monthly until the conclusion of the study. Study outcomes will be determined by comparing outcomes between the baseline (pre-intervention) and follow-up period.
Primary outcome [2] 338820 0
Proportion of patients who have their cancer therapy stopped, altered, or interrupted due to CV event, competing risk, cancer or CV risk, CV morbidity or other CV-related reason. (primary effectiveness outcome). This will be assessed as a composite outcome.
Assessment method [2] 338820 0
Change in the proportion of patients who have their cancer therapy stopped, altered, or interrupted due to CV event, competing risk, cancer or CV risk, CV morbidity or other CV-related reason. Assessed via review of medical records.
Timepoint [2] 338820 0
Electronic health records data to be extracted for each eligible patient during the study period assessed monthly until the conclusion of the study. Study outcomes will be determined by comparing outcomes between the baseline (pre-intervention) and follow-up period.
Primary outcome [3] 338821 0
Proportion of patients seen in the IMPACT-CVD in CANCER clinic who have their cancer therapy stopped, altered, or interrupted due to CV event, competing risk, Cancer or CV risk, CV morbidity or other CV-related reason. This will be assessed as a composite outcome.
Assessment method [3] 338821 0
Change in the proportion of patients seen in the IMPACT-CVD in CANCER clinic who have their cancer therapy stopped, altered, or interrupted due to CV event, competing risk, Cancer or CV risk, CV morbidity or other CV-related reason (ie not managed according to conventional Australian guidelines for prevention of cancer or CVD) (aligning with Domains 2 & 3 of the quality indicators). Assessed via review of medical records.
Timepoint [3] 338821 0
Electronic health records data to be extracted for each eligible patient during the study period assessed monthly until the conclusion of the study. Study outcomes will be determined by comparing outcomes between the baseline (pre-intervention) and follow-up period.
Secondary outcome [1] 437022 0
Quality of life
Assessment method [1] 437022 0
Quality of life will be assessed using the EQ-5D-5L.
Timepoint [1] 437022 0
Cross-sectional data collection. Repeated cross-sectional outcome data will be gathered across all three sites for the total study duration and data collection period of 30 months. Patients will be invited to complete surveys at their clinic appointment and via mailout at baseline and follow-up (6 months and 12 months post-enrolment). Study outcomes will be determined by comparing outcomes between the baseline (pre-intervention) and follow-up period.
Secondary outcome [2] 437023 0
Depression
Assessment method [2] 437023 0
14-item Hospital Anxiety and Depression Scale (HADS)
Timepoint [2] 437023 0
Cross-sectional data collection. Repeated cross-sectional outcome data will be gathered across all three sites for the total study duration and data collection period of 30 months. Patients will be invited to complete surveys at their clinic appointment and via mailout at baseline and follow-up (6 months and 12 months post-enrolment). Study outcomes will be determined by comparing outcomes between the baseline (pre-intervention) and follow-up period.
Secondary outcome [3] 437592 0
Health Status
Assessment method [3] 437592 0
The 23 item Kansas City Cardiomyopathy Questionnaire (KCCQ) will be used to measure symptoms, physical and social limitations, and quality of life
Timepoint [3] 437592 0
Cross-sectional data collection. Repeated cross-sectional outcome data will be gathered across all three sites for the total study duration and data collection period of 30 months. Patients will be invited to complete surveys at their clinic appointment and via mailout at baseline and follow-up (6 months and 12 months post-enrolment). Study outcomes will be determined by comparing outcomes between the baseline (pre-intervention) and follow-up period.
Secondary outcome [4] 437593 0
Cardiovascular admission/re-admission rate. This will be assessed as a composite outcome.
Assessment method [4] 437593 0
Proportion of patients who have a cardiovascular-related hospital admission or re-admission during the study period. Assessed via review of medical records.
Timepoint [4] 437593 0
Electronic health records data to be extracted for each eligible patient during the study period, assessed monthly until the conclusion of the study. Study outcomes will be determined by comparing outcomes between the baseline (pre-intervention) and follow-up period.
Secondary outcome [5] 437594 0
Cancer-associated mortality
Assessment method [5] 437594 0
Cancer-associated mortality rate during the study period. Assessed via review of medical records.
Timepoint [5] 437594 0
Continuous cross-sectional data collection. Electronic health records data to be extracted for each eligible patient during the study period, assessed monthly until the conclusion of the study. Repeated cross-sectional outcome data will be gathered across all three sites for the total study duration and data collection period of 30 months Study outcomes will be determined by comparing outcomes between the baseline (pre-intervention) and follow-up period.
Secondary outcome [6] 437595 0
Health service utilization
Assessment method [6] 437595 0
The implementation costs and within-clinic resource use will be micro-costed. Downstream health service utilisation will be founded on a combination of patient survey data (via 6 and or 12-month follow-up surveys) and administrative records from medical records. These events will be valued using national price determinations.
Timepoint [6] 437595 0
Continuous cross-sectional data collection. Electronic health records data to be extracted for each eligible patient during the study period. Patients will be invited to complete surveys at their clinic appointment (baseline) and via mailout (at 6 and 12 months post-enrolment). Repeated cross-sectional outcome data from medical records will be gathered across all three sites for the total study duration and data collection period of 30 months. Study outcomes will be determined by comparing outcomes between the baseline (pre-intervention) and follow-up period.
Secondary outcome [7] 437596 0
Patient empowerment
Assessment method [7] 437596 0
Measured by the 13-item Patient Activation Measurement (PAM) assessing knowledge, skill, and confidence for managing health and healthcare.
Timepoint [7] 437596 0
Cross-sectional data collection. Repeated cross-sectional outcome data will be gathered across all three sites for the total study duration and data collection period of 30 months. Patients will be invited to complete surveys at their clinic appointment (baseline) and via mailout (at 6 and 12 months post-enrolment). Study outcomes will be determined by comparing outcomes between the baseline (pre-intervention) and follow-up period.
Secondary outcome [8] 437597 0
Patient experience
Assessment method [8] 437597 0
Patient Assessment of Care for Chronic Conditions (PACIC). This validated tool includes 20 items and measures specific actions or qualities of care, congruent with the Chronic Care Model, that patients report they have experienced in the delivery system.
Timepoint [8] 437597 0
Cross-sectional data collection. Repeated cross-sectional outcome data will be gathered across all three sites for the total study duration and data collection period of 30 months. Patients will be invited to complete surveys at their clinic appointment (baseline) and via mailout (at 6 and 12 months post-enrolment). Study outcomes will be determined by comparing outcomes between the baseline (pre-intervention) and follow-up period.
Secondary outcome [9] 437598 0
Modifiable behavioural risk factors. This will be assessed as a composite outcome.
Assessment method [9] 437598 0
Validated tools and items will examine modifiable health risk factors. These include smoking status (smoker [daily, weekly, other], ex-smoker and never smoked), alcohol consumption (using the 3-item consumption short form of the Alcohol Use Disorders Identification Test [AUDIT-C]), diet (average serves of fruit and vegetables per day, with diet risk: <7 serves per day),) and physical activity level (duration of vigorous and moderate physical activity each week)); and height and weight for BMI calculation to determine overweight and obesity. This will be assessed as a composite outcome, with total number of risk factors determined.
Timepoint [9] 437598 0
Cross-sectional data collection. Repeated cross-sectional outcome data will be gathered across all three sites for the total study duration and data collection period of 30 months. Patients will be invited to complete surveys at their clinic appointment (baseline) and via mailout (6 and 12 months post-enrolment). Study outcomes will be determined by comparing outcomes between the baseline (pre-intervention) and follow-up period.
Secondary outcome [10] 437601 0
Barriers and facilitators to implementation and sustainability of the clinic. This will be assessed as a composite outcome.
Assessment method [10] 437601 0
The fidelity of what was implemented will be examined through the following. (i) Reach and adoption. The extent to which the target audience (patients with cancer receives the intervention will be examined by the documented number of patients who 1) are referred to the cardio-oncology clinic and 2) attend the cardio-oncology clinic. Cardiologist, oncologist, and nurse views about the implementation and sustainability of the intervention will be assessed at each site via a qualitative telephone interview/survey to explore their thoughts on the intervention.
Timepoint [10] 437601 0
Final month of the intervention phase/study (30 months post study commencement).
Secondary outcome [11] 438530 0
Cardiovascular mortality rate
Assessment method [11] 438530 0
Proportion of patients who have a cardiovascular-related death during the study period. Assessed via review of medical records.
Timepoint [11] 438530 0
Electronic health records data to be extracted for each eligible patient during the study period, assessed monthly until the conclusion of the study. Study outcomes will be determined by comparing outcomes between the baseline (pre-intervention) and follow-up period.

Eligibility
Key inclusion criteria
1. Patients aged 18 years or over, and diagnosed with cancer; and
2. Planned for anti-cancer therapy, known to cause cardiovascular toxicity
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who already have an active follow-up with a cardiologist.
2. Life expectancy <12 months: Oncologic (or other) life expectancy <12 months or any other medical condition (including pregnancy) that results in the belief (deemed by the Chief Investigators) that it is not appropriate for the patient to participate in this trial.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Stepped wedge-controlled trial with a hybrid II design. The intervention and implementation strategies will be delivered sequentially at 3 sites at 3-monthly intervals, after a prospective pre-intervention period of 8 months at the first site, with a total study duration and data collection period of 30 months.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All dichotomous outcomes in this three-site, stepped wedge trial will be analysed using fixed effects logistic regression models (as appropriate with a small number of sites), controlling for site and period (pre vs post). The estimated coefficients for period will be presented as odds ratios, and (two-tailed) hypothesis tests will be performed to test the null hypothesis that the period odds ratio is equal to 1.0. Interrupted timeseries analyses will be performed within each site using a segmented regression model (fixed effects for time pre, time post, and period), with the coefficient of time post reflecting any change in the outcome trends beyond any trend in the pre intervention period.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
1/09/2026
Actual
Date of last data collection
Anticipated
1/09/2027
Actual
Sample size
Target
2100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26799 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 26802 0
Maitland Hospital - Maitland
Recruitment hospital [3] 26803 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment postcode(s) [1] 42850 0
2298 - Waratah
Recruitment postcode(s) [2] 42853 0
5573 - Maitland
Recruitment postcode(s) [3] 42854 0
2340 - Tamworth

Funding & Sponsors
Funding source category [1] 316773 0
Government body
Name [1] 316773 0
Cancer Institute NSW
Country [1] 316773 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Country
Australia
Secondary sponsor category [1] 318989 0
None
Name [1] 318989 0
Country [1] 318989 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315541 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 315541 0
Ethics committee country [1] 315541 0
Australia
Date submitted for ethics approval [1] 315541 0
30/04/2024
Approval date [1] 315541 0
14/05/2024
Ethics approval number [1] 315541 0
Ethics committee name [2] 315723 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 315723 0
Ethics committee country [2] 315723 0
Australia
Date submitted for ethics approval [2] 315723 0
Approval date [2] 315723 0
Ethics approval number [2] 315723 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 135022 0
Prof Aaron Sverdlov
Address 135022 0
University of Newcastle, University Drive, Callaghan NSW 2308
Country 135022 0
Australia
Phone 135022 0
+61 2 4042 0725
Email 135022 0
aaron.sverdlov@newcastle.edu.au
Contact person for public queries
Name 135023 0
Aaron Sverdlov
Address 135023 0
University of Newcastle, University Drive, Callaghan NSW 2308
Country 135023 0
Australia
Phone 135023 0
+61 2 4042 0725
Email 135023 0
aaron.sverdlov@newcastle.edu.au
Contact person for scientific queries
Name 135024 0
Aaron Sverdlov
Address 135024 0
University of Newcastle, University Drive, Callaghan NSW 2308
Country 135024 0
Australia
Phone 135024 0
+61 2 4042 0725
Email 135024 0
aaron.sverdlov@newcastle.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Data from this study are not publicly available because of ethical restrictions on data sharing due to the need to protect patient confidentiality. Under the terms of our approval, it is required that access to data is restricted to study personnel only.



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.