Cardiac Rehabilitation for Breast Cancer Survivors at Risk for Cardiovascular Disease Secondary to Cardiotoxic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
Women with breast cancer treated using anthracyclines and/or trastuzumab are at an increased risk of cardiovascular disease (CVD) following treatment completion. Exercise is known to reduce CVD risk in healthy and several clinical populations, but, whether existing cardiac rehabilitation programs can be leveraged to reduce CVD risk in breast cancer survivors is unknown. This study aims to: i) understand the feasibility of virtual versus in-person cardiac rehabilitation in breast cancer survivors; and ii) compare the effect of virtual versus in-person cardiac rehabilitation on cardiovascular function and injury biomarkers, physical fitness, and psychosocial health. 50 breast cancer survivors with increased CVD risk will be recruited and randomized to either the in-person or virtual arm of the cardiac rehabilitation program at Women's College Hospital (WCH). Data will be collected at baseline, following program completion, and 6-months after program completion. The primary outcomes are measures of study feasibility. Other clinically relevant outcomes to be collected include: i) imaging and blood-based biomarkers of cardiovascular function; ii) physical fitness; iii) objective and self-reported physical activity levels; and iv) self-reported measures of psychosocial wellbeing. These findings will be used to inform the design of a larger-scale cardio-oncology trial and will facilitate development of more comprehensive CVD risk management strategies for breast cancer survivors at WCH.
详细描述
Rationale Our overarching goal is to support the development of innovative and scalable approaches to CVD prevention in early breast cancer (EBC) survivors. Cardiac rehabilitation (CR) is a cornerstone of both primary and secondary CVD risk management and may be similarly beneficial for survivors at risk of cancer-related CVD. However, it remains unknown if CR-based interventions can reduce CVD risk in those who have received cardiotoxic therapies. Further, the impact of exercise setting (i.e., in-person versus virtual) on intervention safety, adherence, and efficacy has also not been evaluated in this context. Lastly, whether psychosocial wellbeing affects program participation is also not well understood. Ultimately, our study will provide important pilot and feasibility data to inform future randomized trials in this area. It will also lay the foundation for a prospective cohort study that can evaluate the importance of biomarkers and clinical risk factors in predicting future CVD and will provide data that will help identify individuals who are most likely to benefit from aggressive CVD risk factor management.
Design The proposed study is a pragmatic randomized trial of in-person supervised versus virtually delivered CR in EBC survivors treated with anthracyclines and/or trastuzumab. The investigators will also study the evolution of cardiovascular risk markers in women with breast cancer after completion of potentially cardiotoxic chemotherapy.
Objectives and hypotheses
Our specific objectives and related hypotheses are:
- Primary objective: Assess the feasibility of conducting an adequately powered randomized trial of supervised versus virtual CR in older women (>50 years) with breast cancer who have been treated with anthracyclines and/or trastuzumab Hypothesis: The trial will demonstrate feasibility via the achievement of pre-determined thresholds for participant recruitment, retention, and intervention adherence to CR protocols.
- Secondary objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age > 50 years
- •previous receipt of anthracyclines and/or trastuzumab for breast cancer
- •ability to participate in in-person cardiac rehabilitation
排除标准
- •medical contraindications that preclude safe exercise participation17
- •unwillingness to comply with study protocols.
研究组 & 干预措施
In-person cardiac rehabilitation
Those randomized to in-person cardiac rehabilitation group
干预措施: In-person supervised cardiac rehabilitation (Behavioral)
Virtual cardiac rehabilitation
Those randomized to the virtual, home-based rehabilitation group
干预措施: Virtual cardiac rehabilitation (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: 1 week after study completion
Defined as number of patients who agree to participate relative to the number of patients approached.
Intervention safety
时间窗: 1 week post-intervention
Data on all intervention-related adverse events (as defined by the Common Terminology Criteria for Adverse Events \[CTCAE\]) will be collected and reported according to CTCAE-defined categories. Non-trial related adverse events during the intervention period will also be recorded given that they may significantly impact participation.
Reasons for drop-out
时间窗: 1 week post-intervention
Reasons for dropout and/or non-compliance to assessment protocols will also be collected.
Study retention
时间窗: 1 week post-intervention
Retention will be assessed by measuring attrition throughout the intervention period.
Intervention adherence
时间窗: 1 week post-intervention
Exercise adherence will be collected as relative dose intensity (RDI; exercise dose performed in each session relative to prescribed exercise dose).
Participant satisfaction
时间窗: 1 week post-intervention
Satisfaction with the intervention and participant experiences will be collected via an investigator-created survey.
次要结局
- Estimated aerobic fitness(2 weeks before starting cardiac rehabilitation and 1 week after completing cardiac rehabilitation)
- Work Limitations Questionnaire(2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation)
- Left ventricular ejection fraction (LVEF)(2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation)
- E/A ratio(2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation)
- Duke Activity Status Index(2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation)
- Godin Leisure Time Exercise Questionnaire(2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation)
- Global longitudinal strain (GLS)(2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation)
- Automated Self-Administered Dietary Assessment Tool (ASA24)(2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation)
- Objective assessment of physical activity levels(1 week after completing cardiac rehabilitation)
- Beck Depression Inventory(2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation)
- Short-form survey (SF-36)(2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation)
研究者
Husam Abdel-Qadir
Cardiologist
Women's College Hospital