Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Assessment of Patient Interest in Protocol
研究概览
简要总结
To provide critical participant enrollment data necessary to complete a larger definitive clinical trial in the future.
详细描述
This study is a 2-arm, parallel design, single-blind randomized controlled pilot study designed to compare the effects of a tailored multi-level physical activity intervention (PAI) vs healthy living intervention (HLI) on exercise capacity, cardiovascular and cognitive function, health-related quality of life (QOL), strength and fatigue among lymphoma and breast cancer patients undergoing active treatment with anthracycline based chemotherapy (anthra-bC).
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects age 18-85 years old
- •Stage I-IV Hodgkin's (HL) or Non-Hodgkin's Lymphoma (NHL) or I-III Breast Cancer patients who are receiving (within 6 weeks of initiation) or are scheduled to receive potentially cardiotoxic systemic therapies (e.g. chemotherapy regimens [anthracyclines, trastuzumab]), immuno-therapies (immune checkpoint inhibitors [ICI's]), hormonal therapies (aromatase inhibitors) or radiation (within 8 weeks of completion).
排除标准
- •Evidence of COVID19 within the last 60 days or recent (21 days) exposure to close personal contact who has tested positive for COVID
- •Uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg)
- •A recent history of alcohol or drug abuse
- •Inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion
- •Other exclusions include those with contraindications to MRI; unstable angina; inability to exercise on a treadmill or stationary cycle; significant ventricular arrhythmias (>20 PVCs/min due to gating difficulty); atrial fibrillation with uncontrolled ventricular response; acute myocardial infarction within 28 days; claustrophobia; pregnancy; those unable to provide informed consent (able to read and write English); or moving within 12 mos. of enrollment.
结局指标
主要结局
Assessment of Patient Interest in Protocol
时间窗: 6 Months
Feasibility for a larger study will be determined by the number of patients that agree to participate in the trial.
Assessment of Patient Compliance
时间窗: 6 Months
Data collected will determine how many patients complete all protocol activities to determine feasibility of the interventions.
Assessment of Patient Response to Interventions
时间窗: 6 Months
Examination of qualitative data to evaluate positive and negative influences on adherence and to refine the intervention for a future large scale utilizing recorded interviews with each of the accrued subjects.
次要结局
- Assessment of Oxygen Output(6 Months)
- Assessment of Cardiac Output(6 Months)
- Assessment of Health Related Quality of Life(6 Months)
- Assessment of Renal Function(6 Months)
- Assessment for Anemia(6 Months)
- Assessment of Fatigue(6 Months)
- Assessment of General Health(6 Months)