A Prospective Study of Physical Function in Adults Who Receive Systemic Therapy for Stage I-III Gastroesophageal Cancer (FAST-GO)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in SPPB
研究概览
简要总结
This study evaluates how the treatment for gastroesophageal cancer affects physical function in patients who receive chemotherapy as part of their treatment for gastroesophageal cancer.
详细描述
PRIMARY OBJECTIVE:
I. To determine the change in physical function from baseline to 6 months of treatment, as measured by the short physical performance battery (SPPB).
OUTLINE: This is an observational study.
Patients undergo blood sample collection as well as complete surveys, physical function tests and may complete an interview on study.
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
- •* Adults ≥ 18 years old at the start of study treatment.
- •New diagnosis of early-stage (Stage I, II, III) esophageal, gastroesophageal junction, or gastric adenocarcinoma, squamous cell carcinoma, or poorly differentiated carcinoma.
- •Plan to start systemic therapy for resectable or potentially resectable disease.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •* Patients with stage I disease with plans to undergo endoscopic resection or surgery alone without perioperative systemic therapy.
- •Metastatic disease at the time of diagnosis.
- •Patients who are unable to provide informed consent.
- •Any condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.
- •Currently participating in another intervention research study seeking to improve functional status, alleviate frailty, increase muscle strength, or improve cognitive function.
结局指标
主要结局
Change in SPPB
时间窗: Through the end of cancer treatment, an average of 6 months
Will characterize the levels of function at each time point and longitudinal changes in function using descriptive statistics (means, SDs, change scores) in the overall patient sample and by pre-treatment/treatment variables. To assess the associations between pre-treatment/treatment variables and change in function, we will use linear regression models with SPPB change score from baseline to 6 months as the dependent variable and pre-treatment demographic, clinical, and geriatric assessment characteristics as the predictor variables, controlling for the patient's pre-treatment level of function. Potential predictors will be examined individually and in a parsimonious multivariable model. We will also fit linear mixed models for each outcome variable using measurements at all time points and examine differences in change over time by pre-treatment/treatment variables using interaction terms. Time will be treated as a categorical variable, using indicator variables of time.
次要结局
未报告次要终点