Multidisciplinary Team IntervenTion in CArdio-ONcology
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- cardiac MRI
研究概览
简要总结
People with breast cancer often experience many short and long-term side effects as a result of both the cancer and the necessary treatments.
Receiving extra assessments and care from teams of multiple health professionals has been shown to be helpful for people with other health problems, such as heart disease. These 'multidisciplinary' teams may include nurses, doctors, pharmacists, dietitians, exercise therapists, counselors, and other specialists. Currently, the investigators do not know if receiving extra assessments from a multidisciplinary team is helpful for people receiving cancer treatment.
In this study, the investigators hope to learn the effect of extra assessments and early interventions from teams of health care professionals in people diagnosed with cancer, during and after the treatment period.
After initial assessments, participants will be randomized to multidisciplinary team intervention or usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed malignancy (breast or lymphoma);
- •scheduled to receive anthracycline and/or trastuzumab-based chemotherapy;
- •age ≥ 18 years;
- •willing to attend follow-up visits.
排除标准
- •physical disability preventing exercise testing or DEXA scan;
- •psychiatric disease or disorder precluding informed consent;
- •participation in other cardiotoxicity or exercise intervention study;
- •contraindication to anti-cancer therapy, including known heart failure, cardiomyopathy, or baseline LVEF < 50%;
- •previous anthracycline or trastuzumab-based therapy;
- •previous radiotherapy to thorax.
研究组 & 干预措施
multidisciplinary team intervention
Intervention arm receives regular assessments and treatments from cardiology team, clinical nutrition, pharmacist, exercise physiologist and physiotherapist
干预措施: Multidisciplinary team intervention (Behavioral)
Observational arm
Participants randomized to observational arm will receive usual care.
结局指标
主要结局
cardiac MRI
时间窗: change from baseline to 12 months
left ventricular ejection fraction (LVEF)
次要结局
- serum biomarkers(change from baseline to 12 months)