Exercise in All ChemoTherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Assess Feasibility
研究概览
简要总结
Exercise in all Chemotherapy (EnACT) is a study to assess safety, feasibility, and acceptability of an exercise program within chemotherapy. This will be a single group study to capture the effects of an exercise intervention on the average chemotherapy patient and the patients compliance to the study.
详细描述
Several national and international agencies recommend exercise participation for all persons following a cancer diagnosis. The current evidence suggests that exercise training is safe during primary adjuvant therapy and improves physical function and quality of life outcomes. Moderate exercise has been shown to improve fatigue (extreme tiredness), anxiety, and self-esteem. It also helps heart and blood vessel fitness, muscle strength, and body composition. However, despite guidance on implementing exercise recommendations for cancer patients, exercise counseling is still not standard of care in cancer centers across the U.S. Our goal is to collect data that will assist with translation of the evidence from randomized clinical trials into standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Males and females ≥18 years of age
- •Fluent in written and spoken English
- •Must be able to provide and understand informed consent
- •Must have an ECOG PS of ≤ 2
- •Diagnosed with a solid tumor malignancy
- •Cancer patients (stage 1-4)
- •Scheduled to receive chemotherapy at Penn State Cancer Institute
- •Absence of absolute contraindications for exercise according to the American Heart Association
- •Primary attending oncologist approval
排除标准
- •Receiving chemotherapy at a location other than Penn State Cancer Institute
- •Not fluent in written and spoken English
- •Hematological malignancy
- •Evidence in the medical record of an absolute contraindication for exercise
- •Cardiac exclusion criteria:
- •Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
- •History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty or stenting within the past 6 months prior to the start of chemotherapy
- •Uncontrolled arrhythmias; patients with rate controlled atrial fibrillation for >1 month prior to start of chemotherapy may be eligible
- •acute myocarditis, pericarditis, or endocarditis
- •acute pulmonary embolus or pulmonary infarction
- •thrombosis of lower extremities
- •suspected dissecting aneurysm
- •pulmonary edema
- •respiratory failure
- •acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
- •mental impairment leading to inability to cooperate
- •Non-English speaking
- •Pregnant women
- •Children (the protocol will only include individuals 18 and older)
研究组 & 干预措施
Intervention Group
Exercise intervention
干预措施: Exercise Intervention (Behavioral)
结局指标
主要结局
Assess Feasibility
时间窗: Feasibility will be assessed at the completion of the study for each patient (average of 5 months of chemotherapy).
Feasibility will be obtained if one third of chemotherapy patients actually do the exercise prescribed (one exercise session per week for four weeks).
次要结局
- Compare changes in pain, physical function, nausea, vomiting, arthralgias, chemotherapy alterations (dose delays and alterations).(Surveys will be given once the patient is consented and again at the completion of the study for each patient (average of 5 months per patient).)
- Assessing safety through number of patients with injuries related to the intervention(A standardized survey for assessing injuries will be used and administered at the end of the patients chemotherapy (average of 5 months)..)
- Qualitative assessments of clinician perspectives regarding the study. At the end of the study clinicians will be asked a series of qualitative questions to gain their insight into the study.(Surveys will be provided to clinicians at the completion of the study (up to 38 months))
- Assess Acceptability(Acceptability will be assessed at the completion of the study for each patient (average of 5 months of chemotherapy).)
研究者
Kathryn Schmitz
Professor, Public Health Science
Milton S. Hershey Medical Center