Assessing Performance Status in Cancer Patients Using Cardiopulmonary Exercise Testing and Wearable Data Generation: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Proportion of patients being approached that agree to participate in the study
研究概览
简要总结
The primary objective of this study is to establish the feasibility and value of physical fitness assessment within patients receiving cytotoxic chemotherapy. If successful, this project will establish the groundwork for physical function assessment in larger cancer clinical trials to assist patient selection and evaluation of toxicity and/or response among trial participants.
详细描述
Physical fitness, whether measured by performance capacity or daily activity, can predict risk of toxicity while helping to evaluate toxicity itself in the course of cancer chemotherapy. Cytotoxic chemotherapy causes premature aging and frailty in many cancer patients, so measuring and improving physical function may also limit late morbidity and mortality. Clinician-rated performance status (cPS; e.g., ECOG or Karnofsky PS) with or without concomitant organ function testing is the usual gold standard for risk prognostication and patient selection in most cancer settings, but cPS is subjective, unreliable, and relatively sensitive only for patients with significant functional compromise. Objective evaluations of physical function have the potential to augment or even replace cPS in the cancer treatment setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients receiving cytotoxic chemotherapy with at least a 3 week cycle (either adjuvant/curative or palliative)
- •Age ≥ 18, prioritizing patients ≥ 60 years
- •At least 6 weeks out from surgical resection
- •Presence of working email address
- •Access to internet at home and either access to wireless internet or cellular data reception
- •Ability to read and understand English
- •Ability to understand and comply with study procedures
排除标准
- •Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent
- •Contraindication to CPET per standard American Thoracic Society (ATS) guidelines
结局指标
主要结局
Proportion of patients being approached that agree to participate in the study
时间窗: 12 months
Measure 1 for study feasibility
Proportion of patients who wear HealthPatch and have data captured successfully for at least 75% of the time
时间窗: 12 months
Measure 3 for study feasibility
Patients who wear Philips Actiwatch and have data captured successfully for at least 75% of the time
时间窗: 12 months
Measure 4 for study feasibility
Proportion of patients who complete both baseline and follow up CPET tests without significant testing-related adverse events
时间窗: 12 months
Measure 2 for study feasibility
Proportion of patients for whom all data is successfully recorded within the database
时间窗: 12 months
Measure 5 for study feasibility
次要结局
- VO2max measured both pre- and post-chemotherapy(12 months)
- 6 Minute Walk Distance (6MWD)(12 months)
- Clinician-rated performance status(12 months)
- Patient activity/steps per day(12 months)
- Heart rate(12 months)
- Sleep duration(12 months)
- Patient-reported sympotomatic toxicity and quality of life(12 months)
- Incidence and number of falls(12 months)